Before CCRPS Maria Lopez was an experienced physician with a background in medical devices, looking to expand her role within clinical research. After CCRPS Maria ascended to the role of Chief Medical Officer at a CRO in Columbia, specializing in medical devices, significantly enhancing her expertise in clinical research operations.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Maria's insights provide a profound view of the impact that the CCRPS certification program has had on her professional capabilities and her organization's services.

Key Takeaways

● Maria appreciated how the course was structured, which allowed her to develop a deep understanding of clinical research administration, particularly in the context of medical devices.

● The inclusion of templates and structured guidance within the course enabled Maria to streamline her workflow and implement standardized procedures at her CRO.

● The focus on quality and safety in the course resonated with Maria’s values as a physician, empowering her to uphold high standards in her organization's research practices.

Recommendations to Colleagues:

● Maria strongly recommends the CCRPS course to her peers, emphasizing its comprehensive coverage of clinical trials, its practical utility, and the continuous access to updated content, ensuring that learners stay informed of the latest industry standards and regulations.

Career Advancement:

● The CCRPS certification was pivotal in Maria’s promotion to Chief Medical Officer, where she now plays a crucial role in expanding her company’s services to include clinical research for medical devices, demonstrating the direct career benefits of the program.

Insights for Future Improvement:

● Maria suggested enhancements to the course, including more interactive teaching methods beyond slide reading and better follow-up on participant inquiries to strengthen the learning experience.

@0:00 Courtney Fulkerson: "All right. First of all, thank you for meeting with me today and we're pretty much just going to kind of go through some questions and get your feedback on the program and things that you like about it, things you didn't and pretty much just to tailor the program from here on out like any feedback."

@1:15 Maria Lopez: "It was really important for me, the part where we're at it. I mean, you usually know the basics of the history of political research, but it was like a really wide and long, it gave me a lot of information about it in a timeline. It was many things I didn't know. And now I have a wider structure about it. It was really from the beginning was like, wow, they usually go really fast through ethics, but it was really important."

@2:30 Maria Lopez: "The other thing that I loved is you gave us a lot of templates and for example, letter structures, then you can start using them that when you now have a file of papers that I don't have to have a changed name, the log. Oh, I've got a little bit more of my devices, but not only the knowledge, but now have a lot of papers that are always ready to start going on. So that is that was amazing. That is the, this is the only course I ever done that I really find that those many times and stuff."

@3:45 Courtney Fulkerson: "Yeah, it's good to hear just any really point of view. And I feel like as long as it was useful and you're able to kind of talk about like the way you've been able to use it, which I know you have a little bit, but we're grateful for any feedback."

@4:50 Maria Lopez: "I was really interested in quality that is like the main thing we are really into it. So quality was when I read what I went over the course, me and my boss, we were ready. It was like, OK, we need this to be like really into quality. Because our CRO, we all of us, I mean, our doctors, we're all physicians, basically, we're physicians. So all everything around quality and safety, it's really important."

@6:10 Courtney Fulkerson: "Right, that's very, I mean, it's important. It's important in anything. But I mean, that's not too good that you found that within our course."

@7:22 Maria Lopez: "You know, me as a non, I mean, I speak my native language Spanish and Sometimes you get into those programs and you have many accents that are so hard, but you didn't. That was really good. I understood like everyone."

@8:55 Courtney Fulkerson: "Good."

@9:10 Maria Lopez: "I'm definitely coming back. I didn't download everything. And I just got it there. And the topics that I feel like not very strong, I've listened to them. Not like starting for the exam, but like listening to it. we were a podcast, listening to them and really getting into them."

Before CCRPS: Hannah Fischer Was A Grant Manager Struggling with Clinical Trial Coordination. After CCRPS She Elevated to Clinical Trial Leader at UCSF, Excelling in Trial Management and Grant Applications, Thanks to Our Clinical Trials Training.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Hannah Fischer’s feedback underscores the significant positive impact of the CCRPS certification program on her professional life. Her experience highlights the program’s effectiveness in enhancing participants' understanding of clinical trials, improving job performance, and facilitating career advancement. This testimonial serves as a strong endorsement of the program’s value to professionals in the clinical trials industry.

Key Takeaways

● Hannah had a very positive experience with the self-paced online format, which she found accommodating to her busy schedule.

● The content was comprehensive and directly applicable to her current role in managing clinical trials, significantly aiding her daily responsibilities and strategic approach.

● Successfully leveraged course content and certification to secure a promotion at work, underscoring the practical benefits and career enhancement potential of the program.

● Enthusiastically recommended the course to colleagues due to its thorough coverage of clinical trials from start to finish.

Career Advancement:

● The certification and the knowledge gained from the course played a crucial role in Hannah securing a promotion at work, illustrating the career enhancement potential of the program.

Course Structure and Content:

● She appreciated the self-paced online format, which was perfectly suited to her busy schedule, allowing her to integrate learning seamlessly with her professional responsibilities.

● The course provided a solid foundation in understanding clinical trials from start to finish, making complex processes understandable and manageable.

@0:00 - Courtney Fulkerson: "Congrats on successfully completing your CCRPS program, and thank you also for taking time to meet with me today. We're pretty much just going to go through some questions and answers just to have a conversation about basically how we can improve the program and then your experience with it and kind of where you're at right now in your professional career. Alright, and if you're ready, we'll go ahead and get started with some questions. Okay, could you share some of your favorite moments from the course that enriched your learning experience?"

@0:48 - Hannah Fischer: "I think that's very beneficial. It would be fun to think about, you know, what is needed in the workplace. It helped me. I worked in grants, so I'm the grant program manager for our department, and we are starting a clinical trial for one of our products. I didn't necessarily have a strong engagement and understanding of how everything works together. I have little pieces; I've done this before, but being on the grant side, having this understanding really helped me put together our new grant, our OC2 grant together, and also trying to help implement this trial with some of the events."

@1:35 - Courtney Fulkerson: "Right, well that's really good to hear. What sort of program were you looking for when you chose CCRPS and were you pleased with the content of the course once you got started?"

@2:12 - Hannah Fischer: "I was looking for something that fit my schedule, had a very busy schedule with us, so when I was looking I was looking for something that was self-paced, but also something that had a good foundation, so it explains everything from start to finish about what all is involved in clinical trials, so that it's not too overwhelming."

@4:12 - Courtney Fulkerson: "Would you consider revisiting the course for a refresher, and is there any specific information that you'd want to see within a refresher course?"

@4:25 - Hannah Fischer: "Yes, I can see how that could help with my job in clinical research. Integrating real-world scenarios would be helpful, just because it's nice to see how this knowledge is applied in the workplace."

@4:50 - Courtney Fulkerson: "And if someone from our program were to ask for recommendations for future editions, such as the 2025 edition coming up, would you be open to sharing a list of recommendations and potentially being featured as a course contributor on a future edition of the course?"

@5:05 - Hannah Fischer: "Absolutely. I'm all for continuing education and helping others. If I can help anyone, please let me help."

@5:19 - Courtney Fulkerson: "Can you share what factors motivated you to choose this course and how it stood out from other options that you might have considered?"

@5:41 - Hannah Fischer: "I was looking for something that was self-paced because of my busy schedule. I needed something that provided a thorough foundation, explaining clinical trials from start to finish, so it matched my needs well. CCRPS offered that, and it was easier to fit it into my schedule."

@6:02 - Courtney Fulkerson: "Great, it checked all your boxes then. Now, can you share about your professional journey prior to embarking on this course and how you envision the course contributing to your career growth?"

@6:26 - Hannah Fischer: "Yes. Before taking this course, I was involved in clinical trials administration and coordination but needed a deeper understanding to write clinical trial grants successfully. The comprehensive nature of this course really helped me improve my understanding, which is crucial for my work in managing grants and coordinating trials."

@7:01 - Courtney Fulkerson: "How long did it take you to complete the course and do you feel like the duration was adequate for your learning?"

@7:14 - Hannah Fischer: "I worked on it periodically over 2-3 months. It could be completed in 1 month if someone focused fully on it. The pace was good — the content was clearly explained and I didn't feel rushed."

@7:45 - Courtney Fulkerson: "After completing the course, how did you update your resume and enhance your professional profile?"

@8:06 - Hannah Fischer: "I added the CCRPS certification to my resume and LinkedIn profile. It gave me credibility and deeper knowledge that set me apart in my field. It's definitely helped in job interviews and discussions within my professional network."

@8:36 - Courtney Fulkerson: "How would you describe your experience with our learning platform? Did it facilitate a smooth and engaging learning process?"

@8:48 - Hannah Fischer: "The platform was easy to navigate and use. The content was accessible, and I could go back to review material as needed, which was very helpful for reinforcing knowledge."

@9:35 - Courtney Fulkerson: "And finally, what part of the course did you find most engaging and beneficial to your professional development?"

@9:48 - Hannah Fischer: "The quizzes were particularly helpful for reinforcing the material. The final exam was also very beneficial as it forced a comprehensive review of everything covered, which solidified my understanding and confidence in the subject matter."

@10:23 - Courtney Fulkerson: "What are some reasons you would recommend this course to others based on your experience?"

@10:30 - Hannah Fischer: "It covers clinical trials thoroughly from start to finish and is helpful for anyone involved in clinical trials. I've recommended it to colleagues because it provides a solid foundation and understanding of the clinical trial process, which is essential for anyone in this field."

@10:44 - Courtney Fulkerson: "And lastly, could you share how your career has advanced since completing the course?"

@10:58 - Hannah Fischer: "Since completing the course, I've been promoted at work. The knowledge I gained through the CCRPS program directly helped me secure a higher position where I now manage more critical aspects of clinical trials. It's been a significant boost to my career."

Scott Boyle's Professional Advancement with CCRPS GCP Certification: From Intern at a CRO to Regulatory Affairs Specialist at UPenn

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Scott Boyle’s feedback underscoring the effectiveness of the GCP certification program in providing essential knowledge and skills for professionals transitioning into or advancing within regulatory affairs. His suggestions for bundling courses and adding detailed workflows indicate areas for potential enhancement that could benefit future learners. Overall, Scott’s experience with the course was highly positive, significantly impacting his professional development and career progression.

Key Takeaways

● Scott found the course straightforward to navigate and access, appreciating the professionalism of the website and the reasonable pricing.

● The self-paced nature of the course was beneficial, allowing Scott to fit the learning into his schedule effectively.

● The course content, especially the Code of Federal Regulations section, was directly applicable to Scott’s job in regulatory affairs, enhancing his confidence and competence.

● Completing the course helped Scott secure a job in regulatory affairs, attributing his success in part to the confidence gained from being GCP certified.

Content Satisfaction:

● The course covered essential GCP elements that were crucial for Scott’s role, particularly the detailed information on regulatory requirements which he found most engaging.

Learning Platform:

● Scott praised the learning platform for its user-friendliness and the ability to revisit the content anytime, which he found helpful for continuous learning.

@1:00 - Courtney Fulkerson:
"You're looking to get a certification or like what made you choose this specific one?"

@1:05 - Scott Boyle:
"It was exactly GCP. It was a great refresher learning course. It wasn't required as part of my current job now. They made me redo my GCP. But overall, I think it was a great refresher and it did help me prepare for my current job now."

@1:37 - Scott Boyle:
"I think maybe if there was like a bundle, like I could do like a GCP and a CRA kind of thing."

@1:48 - Scott Boyle:
"Combining two courses, yeah, because I would say some of them can definitely go hand in hand and others could definitely, I mean, all together work out pretty good."

@2:07 - Scott Boyle:
"So I currently work in regulatory affairs at UPenn. Maybe if there is a regulatory aspect of it, I'm a regulatory affairs specialist. Yeah. could be like a like a workflow process kind of thing like this is how every day is going to work for generalized regulatory affairs specialists. And then once you go to a company, it can vary depending on company policies."

@3:20 - Scott Boyle:
"And is there anything that you would like to see within that if you were to? I already have. I already went on the website recently, and I was just reading through it again about processes. again, the CRF, Title 21, overall, I'd say it was good taking class and what I like most about it is in my account. I can still go back or refer to it whenever I want. I like how it's a one-time thing, and there's not blocked by a bunch of different day walls."

@5:05 - Scott Boyle:
"Yes, I would."

@5:41 - Scott Boyle:
"Um, I would say the website looked the most professional out of all. And the GCP course was reasonably priced at very easy to access. I mean, I think it was like two Google searches and I got right there."

@6:02 - Scott Boyle:
"I do do others, but I think overall it was easy to use. It was very open with what you offered. And I think it was pretty fairly priced at $50."

@6:26 - Scott Boyle:
"So before I took this, I did an internship at a CRO company. And they were talking all about GCP and ICH. And it encouraged me to go out and get the certification. I just didn't know where to go. And going back to the same thing, as I said before, it was very easy to go to Google found this organization right away. And they gave me a pretty informational course and a certification to go along with it. that was very helpful."

@7:27 - Scott Boyle:
"Yeah, I loved that with self paste."

@7:45 - Scott Boyle:
"And then how has it enhanced your professional profile? I would say is it has helped me get my current job now. GCP certified on my resume, and then I even put it on my LinkedIn. And I have I noticed more people requesting to follow me in clinical research because they see some of my credentials."

@8:17 - Scott Boyle:
"I would say it overall was very good because like you said again, it was self-paced and there was an option to, if people wanted to, can like read faster, you could have the person reading speed it up to like times two or times five. That was a good process."

@9:35 - Courtney Fulkerson:
"Good. I'm glad that that made you feel confident and I feel like that is one of the biggest parts of clinical research so it's always good to know."

@10:30 - Scott Boyle:
"The top reasons I'd say is easy to navigate, you make your account, you pay a one-time fee, and then you can always go back to it, which I think is very, very good."

Justin Scott Brathwaite's Career Growth Through the CCRPS Coordinator Course Justin Scott Brathwaite advanced from a Startup Associate to a Senior Startup Specialist after completing the Clinical Research Coordinator course offered by CCRPS.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Justin Scott Brathwaite’s feedback emphasizing the course's strengths in providing comprehensive, relevant content at an affordable price. His career advancement post-course completion serves as a testament to the program's effectiveness in equipping participants with the necessary skills and knowledge for professional growth in clinical research.

Key Takeaways

● The broad knowledge gained from the course has bolstered Justin's confidence, particularly in his ability to understand and manage different roles within clinical research. This is pivotal as he aims to move into a project management role, indicating his readiness to handle more complex tasks and leadership duties.

● Since completing the course, Justin has advanced from a Startup Associate to a Senior Startup Specialist, and he is now taking on responsibilities related to project management. This progression demonstrates the tangible impact of the course on his career trajectory.

● Justin's willingness to recommend the course to others, especially due to its comprehensive content and affordability, underscores his positive evaluation of the program's value. This recommendation reflects his belief in the course's ability to provide foundational knowledge essential for newcomers to the field or those seeking a cost-effective way to enhance their skills.

● Justin's participation in the CRC course significantly improved his grasp of critical aspects such as regulatory standards, ICH guidelines, GCP, and SIV. This comprehensive understanding is crucial for his role in study start-up and aids in his professional efficacy.

Course Value and Effectiveness:

● Justin praised the course for being comprehensive and cost-effective. He found the focus on site perspectives particularly enlightening as it aligned with his work in Startup Associate to Senior Startup Specialist..

Content Relevance:

● The sections on regulatory standards, International Council for Harmonisation (ICH) guidelines, Good Clinical Practice (GCP), and Site Initiation Visits (SIV) were highlighted as the most relevant and beneficial, directly aiding his professional duties.

@0:00 - Justin Scott Brathwaite: "Hey Courtney, how are you?"

@0:27 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "That's perfect. I'm just going to start recording on Zoom as well."

@0:39 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "How are you today?"

@0:40 - Justin Scott Brathwaite: "Doing well."

@1:42 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Could you share some of your favorite moments from the course that enriched your learning experience?"

@1:49 - Justin Scott Brathwaite: "Yeah, I took the clinical research coordinator course. I work in study startup and it was really helpful to understand the coordinator's role since I do a lot of work with sites. I found the SIV, ICH, and GCP sections particularly helpful."

@2:45 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "So it was pretty comprehensive. Good. So you feel like it kind of covered a lot of bases and it was able to translate into what you’re doing now."

@3:10 - Justin Scott Brathwaite: "I was looking for something that was relatively cost-effective and also up to date to expose me to the material. I needed something comprehensive. That's kind of why I chose the program."

@3:59 - Justin Scott Brathwaite: "The content was really good. It was just that sometimes the narration was a bit rushed."

@7:13 - Justin Scott Brathwaite: "I would consider revisiting the course. I think I would do a refresher. I'm thinking about doing the PM one because I just saw there was a project manager course."

@11:00 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "It gave you a little bit of background on the site side of things, I think."

@14:52 - Justin Scott Brathwaite: "The regulatory, ICH, GCP, SIV sections were the most relevant because I deal with a lot of regulatory in this position so it's kind of helped me to leverage that to work with sites."

@16:13 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "And what are some reasons that you would recommend this course to others based on your experience?"

@16:28 - Justin Scott Brathwaite: "I think it's a pretty comprehensive course. The content is there. I think it's especially good for people on a budget."

@17:37 - Justin Scott Brathwaite: "No problem. Thank you, Courtney. Thanks for having me."

Unber Mahmood's case study interview about her experience with the Clinical Research Coordinator (CRC) certification program February 2024 Graduate

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Unber Mahmood's case study reflecting a highly positive experience with the CCRPS's Clinical Research Coordinator program, which not only met her educational needs but also supported her professional growth in the clinical research field. Her feedback provides valuable insights that can help in refining the program further, particularly in enhancing the visual and interactive components of the course.

Key Takeaways

● Unber particularly appreciated the self-paced aspect of the course, which allowed her to balance her responsibilities as a mother and a professional without feeling overwhelmed.

● The course provided all the necessary basics and details needed for a thorough understanding of clinical research, comparable to on-the-job training.

● The availability of instructors for queries and the interactive nature of the platform were crucial in assisting her whenever she encountered difficulties, contributing to a positive learning experience.

● Her motivation to enroll stemmed from a need for a flexible, affordable, and detailed-oriented course that could provide her with the specific knowledge required for a career in clinical research.

Positive Experience with Course Format:

● Unber emphasized the self-paced nature of the course as her favorite aspect, which significantly reduced her stress by allowing her to manage her learning schedule alongside her responsibilities as a mother and a medical professional.

Course Content and Accessibility:

● Unber appreciated the comprehensive and detailed content that did not skip essential parts despite the course's short duration. The platform offered a variety of courses, making it a one-stop resource for various certifications related to clinical research.

@0:32 Courtney Fulkerson: "How are you? Good. So thank you so much for tuning into this call and first of all, congrats on completing this CCRPS program. We're pretty much just going to take some time to go through some questions and kind of hear your feedback on the program and things that you liked about it, things you didn’t and kind of help us tailor the program from here on now. So once you're ready."

@1:00 Unber Mahmood: "Experience. So when I started this course, the most important and the most my favorite thing is that the course was self-paced."

@1:11 Unber Mahmood: "Yes, that was the best part because as a mom and as already working in the job, when I started this course, I did not feel any kind of pressure doing that course that I had to meet the deadlines or I had to do my questionnaires or I actually enjoyed the course only because it was not giving me any kind of pressure. It was self-paced. It was it gives me a time to read it properly and so this was the main part I really enjoyed doing it."

@1:48 Courtney Fulkerson: "Yeah, we get a lot of good feedback on the self-paced portion of it so it definitely helps."

@1:55 Unber Mahmood: "I was in a program where you're looking for when you chose CCRPS and where you pleased the content once you got started. Actually, when I started, I was already working in over-hospital, actually I'm a foreign medical doctor, and I'm already working in a Fairfax hospital. But I always have an interest in clinical research, and because when I was in my university also, I participated in one of the researches with my senior doctors."

@4:00 Courtney Fulkerson: "And looking back, is there any aspect of the course that you feel could have been enhanced to make the learning experience even more rewarding?"

@4:12 Unber Mahmood: "Actually, at some point, I didn't think that it should be, but most of the part was okay, but I think if there was more of a, you know, the drawings part, you can say?"

@4:30 Unber Mahmood: "Because for me, I don't know for other people, like for me, if I'm reading something and it's with the drawings and it's with the charts or it's with the, it becomes more interesting to read to just, to just like prevent that, oh, it's boring just to read the same, just to read the lines. But overall, but it, I don't feel like more often, but yeah, that you could enhance, but if you don't do it also, it's okay."

@6:05 Courtney Fulkerson: "It was the actually the whole website to navigate is very easy."

@6:10 Unber Mahmood: "Like, this is the actually that's the first step. Anybody could actually get attracted to CCRPS because the website itself is very easy to understand. As soon as you open the website, even still, I think I’ve done my course like a little bit in the past. But even still, if I wanted to repeat something, if I wanted to remind something in my in my course, I just sign in, I just go back to my course and just read it again, you know, just to make it understand. So the website itself is very easy. It's just you just see it on the first front page too. It's very easy to navigate to sign in to make your username, password and everything. So it's very easy."

@7:39 Courtney Fulkerson: "Would you ever consider revisiting the course for a refresher? And is there anything specific you want to see within a refresher course?"

@7:47 Unber Mahmood: "In the, um, the refresher course, just keep it self-based."

Celina Moon took the Clinical Research Coordinator (CRC) certification course provided by CCRPS, with a focus on ICH GCP to support her career transition into clinical research.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Celina Moon's feedback provides valuable insights into the strengths and areas for improvement within the ICH GCP course. Her suggestions for more interactive and engaging content delivery, along with the inclusion of practical examples, could enhance the learning experience for future participants, especially those new to the field. Her positive assessment and the constructive criticism will be instrumental in refining the course to better meet learner needs and expectations.A graduate case study interview from Celina, a recent graduate of our ICH GCP course program.

Key Takeaways

● Celina found visual aids such as graphs, tables, and bullet points extremely helpful for her learning style, emphasizing the importance of visual elements in grasping complex information.

● She appreciated the ability to download course materials for future reference, suggesting it added significant value to her learning experience. However, she recommended including real-world documents like informed consent forms to better anchor the theoretical knowledge within practical contexts.

● The course notably boosted Celina’s confidence, reaffirming her decision to transition into clinical research. She found the adverse event/safety reporting section particularly valuable, highlighting the ethical treatment of human subjects, which resonated with her professional values and goals.

Favorite Moments:

● Celina appreciated the course's use of visual aids and the right-hand community feedback section, which helped preview and reinforce key points, aiding in her understanding and retention of course material.

Course Content:

● She was looking for an ICH GCP course to support her career change and found the course's depth and detail both adequate and informative.

Impact on Professional Confidence:

● Completing the course significantly boosted Celina's confidence in her ability to transition into and succeed in the field of clinical research. The course reassured her about her career change and enhanced her understanding of the ethical treatment of human subjects, which was crucial for her professional identity and values.

@2:15 - Celina Moon: "Yes. So what I really actually enjoyed is the parts on the slide that were set up in graphs and tables and bullet points. It just makes a lot more sense to my brain."

@4:39 - Courtney Fulkerson: "That's actually the first time I've heard such good feedback about that part."

@3:17 - Celina Moon: "And I also really liked that on the right-hand side... there was an opportunity where as a learner, I could have put my feedback and some other students kind of did a similar thing, kind of like a cliff notes version."

@3:57 - Courtney Fulkerson: "Those are a couple of features that I thought were really, really neat."

@4:07 - Celina Moon: "The way my brain works is it's very much how the pieces are sitting into the puzzle... And then as I heard all these details, I knew what part of the puzzle was fitting into with that."

@10:06 - Celina Moon: "Yes. So I am very passionate and working very hard for a career pivot... My mom has worked in the field for 25 years and she was one that recommended this course."

@5:59 - Courtney Fulkerson: "And so you got in, you liked the content and just you felt like it was adequate to what you were trying to learn?"

@6:32 - Celina Moon: "It was more. It wasn't more than I expected, but... it helped me gain a better grasp of what I'm getting into."

@31:25 - Celina Moon: "I would definitely revisit it. Like I said, as I already found it, like I was excited, I downloaded the information."

@16:33 - Courtney Fulkerson: "So I'm glad you had a good experience."

@30:24 - Celina Moon: "Oh, I would definitely choose to take it again."

@22:25 - Celina Moon: "Yes, it actually did boost my confidence because at first... And then, you know, I took a deep breath and I started over and, you know, maximum attention, I was like, no, I do get it."

@33:42 - Courtney Fulkerson: "And any input is good input, like I said earlier, so it will help us just refine the course for the future and just meet your graphic. I really appreciate you and I wish you the best of luck."

@33:46 - Celina Moon: "Oh, thank you. I appreciate you too."

Stephanie completed the ICH GCP certification course offered by CCRPS, aiming to build a solid foundation in Good Clinical Practice as she pursued a career in clinical research.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Stephanie’s feedback underscores the effectiveness of the ICH GCP course in providing a solid educational foundation in Good Clinical Practice. Her suggestions for technical improvements point to areas where the course could be enhanced to ensure clarity and engagement for future participants. Overall, her positive experience and the tangible impact on her career trajectory demonstrate the value of the course in preparing graduates for professional roles in clinical research.

Key Takeaways

● Stephanie found the course content comprehensive, providing a good foundational knowledge of ICH GCP, which is crucial for anyone entering clinical research. The video format was highlighted as particularly effective for following along and understanding complex topics.

● The end-of-video exercises were highly beneficial for applying theoretical knowledge to practical situations, enhancing the learning experience by tying concepts to real-world clinical research scenarios.

● Completing the course significantly boosted Stephanie’s confidence, particularly in job interviews, and was instrumental in her securing a role as a research assistant. She specifically found the informed consent section thoroughly beneficial, which directly contributed to her professional capabilities.

Overall Impressions:

● Stephanie appreciated the structured breakdown of the course into distinct topics and categories, which made the content accessible and easy to digest.

Course Format and Accessibility:

● The course’s pacing and structure (divided into 30-60 minute video segments) were well-received, making it manageable within a busy schedule.

Impact on Professional Development:

● The certification added significant value to Stephanie’s resume, enhancing her credibility in the field of clinical research and aiding in her career advancement.

@0:00 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "This meeting is being recorded. Thanks for being here today and sharing your experience with the program. Congrats on finishing it!"

@1:00 - Stephanie: "We didn’t have a course specifically for ICHGCP, and it was really good to get an introduction to how it works and procedures. I liked that it was in video form, which was easier to follow along than just slides or articles."

@1:52 - Stephanie: "At the end, they had those little exercises that you could do. It helped me apply the knowledge that I was learning in a more practical sense and get a sense of how this could be used in the clinical setting."

@2:25 - Stephanie: "I was looking specifically for ICHGCP and something that could help me get certified. I felt that it covered every aspect of GCP and was up to date."

@8:30 - Stephanie: "I added it as a certification in my resume, and I feel it enhanced my profile. It helped make me more credible as someone going into the clinical research field."

@9:17 - Stephanie: "I found the platform was very easy to follow. It was straightforward, and everything was in order, which helps you know exactly where to go and what to do."

@10:14 - Courtney Fulkerson: "What part of the course did you find most engaging and beneficial to your professional development?"

@10:24 - Stephanie: "I really liked learning about informed consent because they went into a lot more detail than I expected."

@11:10 - Stephanie: "I would recommend it because it's self-paced, accessible, and the content is straightforward. It's really good for beginners or even just people who are trying to refresh their memory."

@12:57 - Stephanie: "Thank you. It was really nice speaking to you."

@12:59 - Stephanie: "Thank you. Bye-bye."

Marta Marszalek completed the CCRPS certification course, seeking to deepen her theoretical knowledge and practical skills in clinical research to complement her monitoring activities and comply with industry standards.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Marta Marszalek's feedback underscores the strengths of the CCRPS certification course in the self-paced learning and its adaptability to individual needs. Her constructive suggestions for enhancing lecture delivery and incorporating practical examples provide actionable insights for course developers. Overall, her positive experience and the tangible benefits she derived in terms of career advancement highlight the course's effectiveness in equipping professionals with the necessary skills for clinical research roles.

Key Takeaways

● Marta appreciated the self-paced nature of the course, which allowed her to organize her learning schedule to fit her personal and professional commitments.

● The course significantly boosted Marta’s confidence and prepared her for career advancement, leading to more job offers and enhanced professional credibility.

● The minimalist and visually engaging platform was noted for facilitating a smooth learning process, aligning well with her preference for a straightforward and distraction-free interface.

Overall Impressions:

● Marta found the course well-structured and accessible, particularly valuing the ability to learn independently while having access to external support.

Learning Enhancements:

● Marta appreciated the self-assessment opportunities, which helped identify areas that needed review, although she highlighted the monotonous delivery of some lectures as a point for improvement.

Course Format and Accessibility:

● Open to contributing as a course advisor, Marta is willing to provide recommendations to enhance future editions of the course, reflecting her vested interest in the continuous improvement of the curriculum.

Impact on Professional Development:

● Adding the certification to her CV and LinkedIn profile significantly increased her marketability and helped secure new job opportunities, affirming the practical benefits of the course.

@3:24 - Marta Marszalek: "Probably when I finished, when I started the test, and it was all positive. But actually, I also like the moments when I was not passing this self-evaluation test. And then I knew which part I have to go back, which part I have to go back and learn again. But actually, now I have to say that the most exciting was the beginning, because you know, you are starting with something new."

@4:22 - Marta Marszalek: "Well, it was actually exactly what I was looking for. So because I wanted to find the course that I could learn by myself, but with some external help. So for me, it was important to see the presentations and to find the speakers going through the presentations. So that was what I was looking for. And of course, the certificate gates were important."

@5:00 - Marta Marszalek: "The learning experience, even more rewarding? Like one thing I would consider as a possibility to improvement would be like the lectures but the lectures that were reading the slides. So first it would be better if they just don’t read everything."

@6:26 - Marta Marszalek: "No, I think it was covered pretty much well with theoretical parts. Maybe some like cases would be nice to include. I always like to see with the tests or like evaluations. So you can see like the case and you can evaluate what’s what’s wrong with this one, where’s the mistake or something like that."

@7:26 - Marta Marszalek: "Yes, I think the courses is prepared very well. It’s not very expensive, so it’s very good. I think it can be even more expensive if you can offer more things because people So I think with some improvements I think it could be more expensive but also so, um, the marketing of your, uh, the course is like, it’s, um, it’s not very well, uh, shown. Like, yeah, I think you can show more from the, uh, what you can get from the course."

@8:33 - Marta Marszalek: "If I want to do a refresher course. Yeah. Yeah, definitely."

@10:36 - Marta Marszalek: "So in my case, I needed the certificates to obtain the certificate in very fast, in very fast way. so lots of courses, they would tell you how many hours you can do per week or they are already organized. But in this case, I knew that I would sit. a few days, 10 hours straight, and I can do it. for me, with the flexibility to organize your learning time and schedule, that was very important and the easiness to do this course."

@11:57 - Marta Marszalek: "So I was already working in clinical training. class when I, in the first one, that was, I was not doing, like, strictly monitoring activities, but I was collaborating also for monitoring visits, and for the compliance reasons, I needed the certificate, and I wanted to learn more because I knew the practical parts, and some theory as well, but it’s different when you have to refresh everything and you have to do, it’s like master and with any kind of studies that we’re doing, so in my case it was necessary. I can say I’m not sure if this is because of the certificate or different reasons, but I do receive a lot of offers, job offers, including, for example, yeah, and I’m sure it’s a great value to add to your CV."

@14:00 - Marta Marszalek: "Definitely very easy. That was also one of the reasons that I chose because I was playing with platforms and I’m very like visual person so I need to see that it was simple. It was not like very distracting. I don’t like it but to my images colors and it was very easy. I’m a minimalist person so it’s easy to open it to get there and it was also nice that when you were entering the platform it was you were going to when you left it."

@15:13 - Marta Marszalek: "Basically, what I just said, I think it’s very good for people that they are self-discipline. They like learning new things or they like refreshing things. I think people who are also like challenges, so that’s why you are doing courses when you get some certificate games, it’s always like... Engaging you more in learning something new. Okay. Yeah."

Katie Decker completed the CCRPS certification course, aiming to bolster her extensive practical experience in clinical research with formal training. This certification enhanced her professional profile by validating her knowledge and skills, aligning with industry standards, and preparing her for advanced roles in clinical research.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Katie Decker's feedback from the CCRPS certification program highlights the effectiveness of the course in reinforcing and expanding her knowledge in clinical research. Her suggestions for incorporating more interactive elements and enhancing the marketing of the course's flexibility are valuable insights that could help improve the learning experience for future participants. Overall, her positive review and the tangible benefits she has experienced in her career underscore the value of the CCRPS program in professional development.

Key Takeaways

● Katie appreciated the self-paced online format, which allowed her to manage her learning alongside work commitments efficiently.

● The certification significantly boosted Katie's confidence and enhanced her resume, making it more compelling to potential employers.

Course Experience and Content:

● Katie enjoyed the accomplishment of completing the course and obtaining her certification. She valued the course as a good refresher on research basics and appreciated learning new aspects of clinical research.

Motivation and Outcomes:

● Choosing the course for its self-paced format, Katie needed a certification that could be completed alongside her job without requiring a degree. The course fulfilled these requirements and prepared her for career advancement.

Engaging and Beneficial Course Aspects:

● Taking exams and realizing the depth of her knowledge was particularly satisfying for Katie, reaffirming her competence in her field.

@0:00 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "This meeting is being recorded. Sorry, let me make sure everything. Okay. I think we're good to go. All right. Well, first of all, thank you so much for meeting with me and congrats on completing the CCRPS program."

@0:41 - Katie Decker: "Definitely completing the course, obviously. I worked in research for like seven years now. So it was kind of cool to have like a refresher on the basics and also kind of learning a couple new things here and there. But definitely just completing the course is very accomplishing."

@1:04 - Katie Decker: "Um, so I actually my employer signed me up for the class and everything. Um, originally I worked for a different employer and they were going to have me... I don't know the name of the program, but it was where I actually had to sit for an in-person exam... Um, so this wasn't what I was expecting when I first started the classes and I loved that it was online and kind of self-paced. So, um, it was super like user friendly and very easy and convenient with my work schedule to do."

@3:54 - Katie Decker: "Yeah, definitely. It was nice because I could do it at work and like in between patients kind of hop on and do a couple pages."

@4:10 - Katie Decker: "Definitely. I think for a refresher course, it's always good to kind of refresh on documenting AEs and SAEs and the informed consent process."

@8:19 - Katie Decker: "So I did add the certification on to my personal resume, and then I have a LinkedIn profile and also Indeed. So I have like a picture of like the actual certification with a little serial number and everything on there."

@8:44 - Katie Decker: "And yeah, definitely. And it's nice to when you can, like, if your computer locks or whatever, when you log in, it just brings you right back to where you are, which was really convenient."

@9:00 - Katie Decker: "since ankle and a core research. I just think overall it's just nice to have any kind of extra certification or like a document under your belt... So like for me, like they just called me a coordinator, which I know it's still the same thing. But now I have like the ACRC like my signature and all my name tag, which is nice. So it kind of, you know, always a confidence boost."

@9:32 - Katie Decker: "And this might sound weird, but I guess kind of just taking the exam was kind of just nice like, Oh, I know that. It's easy. the answer to that's so easy. So it kind of just makes me like realize what, wow, I actually do kind of know more of what I'm doing."

@11:03 - Katie Decker: "I think it kind of helps me like be more motivated to go back to school. Eventually, I do want to be a CRA. So I think it's just kind of nice just with already being coordinated for so long. Just having that kind of like title now, like credit it, kind of versus coordinator. It kind of just helps boost my career. It kind of like just makes my resume a little more beefy or two and helps boost my knowledge."

@11:44 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Thank you. I'll send you an email or go get email with your gift card for doing this with me and it should just come through email. But if you have any problems, just definitely reach out to me."

@11:58 - Katie Decker: "Have a good day. You too."

Aishwarya Sukumar completed the CCRPS certification course to enhance her understanding of FDA regulations and adapt to the clinical trials industry in the United States after relocating from abroad. This certification broadened her professional scope, solidified her theoretical foundations, and equipped her for higher positions within clinical research, transitioning from a Clinical Research Coordinator to a Clinical Research Associate role.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Aishwarya Sukumar's feedback underscoring the CCRPS certification program's effectiveness in accommodating diverse learning needs while suggesting areas for enhancement such as increased practical engagement and better support systems. Her progression in her career illustrates the tangible benefits of the course, advocating for its value in professional development within clinical research.

Key Takeaways

● Aishwarya appreciated the self-paced online format which provided the flexibility needed to balance her studies with personal responsibilities.

● The course significantly boosted her confidence, enhanced her resume, and equipped her with the knowledge necessary to progress in her career from a CRC role to a CRA position.

Course Format and Learning Experience:

● The self-paced nature and extended timeline allowed Aishwarya to effectively manage her study schedule without compromising her responsibilities as a new mother.

Motivation for Course Selection:

● Chose the CCRPS program for its affordability and flexibility, crucial as she was adjusting to new motherhood and transitioning careers in a new country.

Professional Growth:

● The course facilitated a smooth transition into the clinical research field in the U.S., providing her with necessary certifications and boosting her credibility in job interviews.

@0:03 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
"This meeting is being recorded."

@2:36 - Aishwarya’s iPhone:
"Sure, please go ahead."

@2:38 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
"Could you share some of your favorite moments from the course that enriched your learning experience?"

@2:45 - Aishwarya’s iPhone:
"So the one thing which I would do is the self-paced thing, which is like much easier for homemakers but to choose my own time and I get to study when I... like my energy is full on so I can go ahead and study and focus more so that’s a good part and the other thing is also they though they give you a time frame of three months you can still go ahead and refresh back to your previous texts or other previous chapters in case you have any questions there you can go ahead and check back and then look back to the newest chapter if you can correlate between those two things yeah so that one was an amazing feature and you may take enough time so they say even those three months you can go up to four months and take your own time and understanding each concepts yeah that was a good part there yeah and I feel like you can just make it fit your schedule and your learning style right yeah right..."

@5:09 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
"Okay, good. And looking back, is there any aspect of the course that you feel could have been enhanced to make the learning experience more rewarding for you?"

@5:23 - Aishwarya’s iPhone:
"Yes, I did feel that at one point because I was stuck with a question because I’ve been going through the programs and I was towards the end of the program."

@6:25 - Aishwarya’s iPhone:
"But in a way that I would say that if this could be a support for job or just like even reaching out to a contacts or somebody who can lead on what path you can take next, that would be a great benefit to the program."

@7:53 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
"So no complaints there And when you were considering enrolling was there any specific information? information on our website that could have better highlighted the benefits of the course?"

@10:11 - Aishwarya’s iPhone:
"So, okay. Yeah, I mean, it’s been a while since I’ve been in the course. have to provide that."

@12:37 - Aishwarya’s iPhone:
"So that is always great to hear. Right."

@14:07 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
"Yeah, that’s, that’s always good. And how long did it take you to complete the course?"

@15:09 - Aishwarya’s iPhone:
"So I started updating my resume with all the information which I learned and I also put my certification as in here because I mean I did receive the certification so I did that."

@15:33 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
"And how would you describe your experience with our learning platform? Did it facilitate a smooth and engaging learning process?"

@16:12 - Aishwarya’s iPhone:
"Yeah, in terms of boosting my confidence because I was like in the New Year in the headlights, I didn’t know many things when I started in here and when I learned the course, kind of learned the new terminologies are the acronyms I would say."

@18:57 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
"And now I’m a CRA as well there. It’s awesome, yeah, so I feel like your career definitely has advanced since you completed the course and Apply what you learned from that into Yeah, I mean, yeah, if time permits everyone that one then I can go ahead and check back like just to refresh my memory Yes, well that completes our interview.

Renata Noronha completed the CCRPS certification to transition from pharmacovigilance to clinical research. This certification enriched her understanding of international PV requirements and helped her secure a job at a clinical research organization, advancing her from an associate to a lead safety associate.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Renata Noronha’s feedback providing valuable insights into the strengths and areas for improvement of the CCRPS certification program. Her positive experience and constructive suggestions will be instrumental in enhancing the course structure, content, and delivery, ultimately enriching the learning experience for future participants aiming to advance their careers in clinical research.

Key Takeaways

● Renata appreciated the clear, structured format of the course, highlighting its ease of follow-through which enhanced her learning experience.

● Enjoyed the global perspective on pharmacovigilance (PV) requirements which added valuable insights applicable to her career in clinical research.

● The certification was pivotal in securing her new role at a clinical research organization, aiding her transition from an associate to a lead safety associate.

● Benefited from the self-paced nature of the course, which allowed her to expedite her learning to align with career opportunities.

Learning Experience:

● Found the course modules well-organized and straightforward, aiding her comprehension and retention of information.

Motivation and Background:

● Chose the CCRPS program to facilitate a career shift from pharmacovigilance to clinical research, driven by the course’s specialized focus and comprehensive coverage of necessary skills and knowledge.

@0:59 Courtney Fulkerson: "Okay. Perfect. Great. Could you share some of your favorite moments from the course that enriched your learning experience?"

@1:05 Renata: "Okay, so I think I found that like easy to follow. I liked it was structured. It was easy to follow. And um, I had previous experience in pharmacovigilance. So it was a bit hard for me to understand Like where like what things are there were a few things that were new to me, especially the reporting with uh, different countries."

@2:33 Renata: "So, I was recently let go from my company. They weren't doing well during COVID, and so it was a natural whole product company, so I did pharmacovigilance for them. When I was looking at jobs in my field, clinical trials were one of them. So, I wanted to get more experience regarding pharmacovigilance first, and then I found this program through one of my friends in clinical research."

@2:33 Courtney Fulkerson: "That sounds like it was a really good fit for what you were looking for. It's great to hear it worked out pretty well for you."

@10:16 Renata: "It is certification. yeah. That’s everything."

@10:18 Courtney Fulkerson: "Okay, so that's good. It sounds like the certification was a significant achievement for you."

@11:04 Renata: "Yeah, I think, like, I think I would."

@12:05 Renata: "So I know that what stood out for me was first, it was clinical research and it was a field that I was interested in getting into, it's specialized. That's important to me."

@12:38 Courtney Fulkerson: "Right, it's always crucial to find a course that not only provides knowledge but also aligns with your career goals."

@15:13 Renata: "Yeah, I had to fast track myself because I got a job, so I had to really buckle down. I helped to have a deadline. So I think I started in November, October and I finished in December. I didn't have a Christmas break, I had to finish the course because my interview was at the end of December."

@16:00 Courtney Fulkerson: "That's quite a commitment! It's impressive that you managed to complete it so quickly."

@16:27 Renata: "Yes, so it's good. I finished it because once I started my job, all the clients we have sponsors they all want your resume. Having that on your resume really helps develop rapport with the sponsors."

@21:29 Renata: "Since I've completed the course, I got a job at a clinical research organization."

@21:35 Courtney Fulkerson: "So that's great. It sounds like the course really helped bridge the gap to your new role."

Dr. Vrushali Borawake transitioned from medicine in India to clinical research in Germany after completing the CCRPS certification. This program enhanced her job interview confidence and provided her with key industry knowledge, enabling her to secure roles as a CRC, CRA, and now a project manager. Dr. Borawake recommends this course to international medical professionals seeking careers in clinical research.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Dr. Vrushali Borawake's feedback underscores the CCRPS program's significant impact on her career transition and advancement. Her suggestions for incorporating more interactive learning tools and her endorsement of the program's applicability across different regulatory environments provide valuable insights for future course enhancements. These improvements could further enrich the program's effectiveness in preparing professionals for successful careers in clinical research.

Key Takeaways

● Dr. Borawake successfully transitioned from medicine in India to clinical research in Germany, attributing significant career advancements to the CCRPS courses.

● She secured positions as a Clinical Research Coordinator (CRC) and Clinical Research Associate (CRA), and has recently advanced to a Project Manager role.

● The courses provided her with essential knowledge and confidence, particularly in job interviews, by familiarizing her with industry-specific terminology and documentation.

● Dr. Borawake highlighted the course's effectiveness for international medical professionals seeking to enter the clinical research field in Germany, noting its comprehensive coverage of relevant regulations and practical applications.

Learning Experience:

● Appreciated the structured approach that covered clinical research from start to finish, which was instrumental in her understanding of the field.
● Found the mix of PDFs, videos, and real-document examples particularly beneficial in preparing for real-world applications.

Application of Knowledge:

● The course content directly influenced her ability to perform effectively in her roles, especially with tasks like site suitability forms and other CRC/CRA responsibilities.

@0:01 Courtney Fulkerson: "Okay. Okay. All right. Well, like I said, we're just going to go through some questions. So whenever you're ready, we're going to get started."

@0:13 Vrushali Borawake: "Yeah."

@0:18 Vrushali Borawake: "Sure, basically it has helped me so much that I've got two courses. So initially when I shifted from India, it was, I was a medical practitioner of an alternative medicine. And then when I shifted to Germany, I was getting calls for a partner job, but not for an associate CRA job. So I did the first course for CRA and then a second course for project management and clinical research."

@0:47 Courtney Fulkerson: "That’s awesome. To come back and decide to do another program."

@0:52 Vrushali Borawake: "So that’s really good. Yeah. Definitely. So the first offer I got was from the first course as a CRA and that was an associate. So the second office they were saying we can offer a project manager position as well so that you can learn hands-on while working. And then I thought okay, I start on the post of me. So I thought before I start, I'll just buy again from CCRPS because this course has always helped. So right now I feel I’m fully prepared for the post of me."

@1:24 Courtney Fulkerson: "That’s awesome, yeah. Well hopefully it all works out and hopefully you’re able to use what you learned from the course into your job."

@1:33 Vrushali Borawake: "So that’s really good. Sure, sure, definitely. So coming to your question from the first course, what I liked about what I found very interesting about CRA course that it was from initially into end of the study and not just like considering that you’re already a coordinator and then you’re shifting to associate side. So the first few slides were differentiation between CRC and CRA and I’m not Because everybody knows that. So while working, there is a difference we monitor in coordinator, but it was very well structured."

@2:38 Courtney Fulkerson: "Good. And so you feel like you were able to kind of put that into practice really as soon as you got into the role."

@2:58 Vrushali Borawake: "Yeah, yeah, immediately. Yeah."

@3:01 Courtney Fulkerson: "Good. Okay. And could you share some of your favorite moments from the course that enrich your learning experience?"

@3:07 Vrushali Borawake: "Oh wait. That’s when I just asked you. so sorry."

@3:09 Courtney Fulkerson: "What sort of program are you looking for when you chose CCRPS and were you pleased with the content of the course once you got started?"

@3:18 Vrushali Borawake: "So I would like you to explain a bit to the question."

@3:23 Courtney Fulkerson: "So what kind of program, whenever you were looking to start a program, kind of what were you looking for and how did our program stand out amongst the other ones and kind of like what aspects were you looking to meet your certain criteria?"

@3:38 Vrushali Borawake: "Sure. when I was searching, I was searching for a coordinated course or something. But to be honest, I went, I always go into chat GPT, I went into chat GPT, but what are the best courses for to land a job as a CRE or CRC and CCRPS definitely comes into first fight. So you have the first two I saw were not online so I had to be in the United States to do that, that is not possible and I think the others I don’t remember but the most suitable was CCAT is because of the online schedule, immediate payment and I think it was also a very reasonable amount, it was around 500 euros, $5.20 or something like that and then I decided for that because of online it was self-paced so I could do at home, initially they had given a timeline that if you follow the schedule you can do it in one month or something but I had like seven days to start my job so I took care of this too, it was very interesting the things that I knew I could skip, that’s a good part but not entire course I could skip that is also good part for people who just want to have a certificate it makes us sure that you attend it and The quiz at the end was also good so I finished the course in three to four days but for the quiz I went through the documents once again just to be sure that I pass it. The best and the most important part was the certificate was generated very easily."

Rabiea transitioned from a physician and pharmacologist in India to a confident drug safety physician after completing her CCRPS certification in pharmacovigilance.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Rabiea's feedback highlights the CCRPS program’s effectiveness in delivering comprehensive and accessible pharmacovigilance training. Her suggestions for interactive enhancements and internship opportunities offer valuable pathways for program improvement, potentially increasing the practical applicability of the course for future learners.

Key Takeaways

● Rabiea appreciated the course's comprehensive nature, noting its gradual build-up from basic concepts to more complex topics in pharmacovigilance.

● The ability to re-listen to video modules and access material from any location was highly valued, enhancing her learning flexibility.

● Detailed modules on regulations and the ARGUS safety database provided her with practical skills and confidence, making her feel job-ready.

Program Structure:

● The curriculum's structured approach in covering pharmacovigilance from fundamentals to advanced topics was effective.

Learning Tools:

● Video modules were particularly useful for revisiting complex concepts, ensuring thorough understanding.

@0:00 - Courtney Fulkerson:
"Hello, how are you?"

@0:02 - Rabiea:
"This meeting is being recorded."

@0:04 - Courtney Fulkerson:
"I'm good. I am just going to start recording on Zoom as well."

@0:12 - Rabiea:
"All right."

@0:14 - Courtney Fulkerson:
"Well, thank you first of all for meeting with me and just taking time to share your experiences with our program and really the plan is just to go through a few question and answer, pretty much just a conversation of your experience with the program and maybe where things can get better, where you, things that you enjoyed and kind of where you are right now in your career. So once you're ready, we'll go ahead and get started."

@0:36 - Rabiea:
"All right."

@0:37 - Courtney Fulkerson:
"I'm good to go. Perfect. Okay. Could you share some of your favorite moments from the course that enriched your learning experience?"

@0:44 - Rabiea:
"First of all, thank you very much for having me here and giving me this platform to share my feelings and experiences about this amazing course. So I would just briefly. I'd like to introduce myself to you for it. I'm a physician and also a pharmacologist. Being a physician and a pharmacologist gives me a strong foundation in health care and pharmaceuticals. I just recognize the importance of enhancing my skill sets through knowledge of pharmacovigilance because I believe that it plays an utmost important role in enhancing the public health and specifically the patient's safety. And I believe that it is critically important for the physicians to understand the importance of reporting and monitoring the side effects of the drug. So this was probably one of the main driving forces at why I chose this sport, so I wanted to be a part of it. And secondly, yes, I wanted to pursue my career as a drug safety physician. And I think when I scrolling down to various forces, I found this course has very comprehensive, you know, course with a very, very complete and comprehensive curriculum. You know, I think the best thing about this certification course was that, you know, it slowly and gradually it builds your knowledge starting from the very, very basics of, you know, the key terminology is a pharmacovigilance. Like what is pharmacovigilance and how can one differentiate between an adverse event and an adverse drug reaction. And then, you know, introduces with the concept of signal detection and risk management. And, you know, so it slowly and gradually it builds your knowledge and starting from the very basics. It, it takes you deeper down into the subject."

@4:27 - Courtney Fulkerson:
"Yeah, it seems like it gave you a good foundation and you were able to kind of see where it fits in where you want to go or maybe where you're able to use it right now as well."

@4:38 - Rabiea:
"Yeah, and I would also like to add about the portion on the ARGIS safety database, so I think it's so good that, you know, those videos, they give you a feeling, you know, after going through all those videos it gives you a feeling that you're actually working on it. And you know, I'm so much confident, you know, Although I'm not a part of any industry right now, but I have a feeling that as soon as I get a job and I get to work on that ARGA safety database, I think it will not be something new to me. I'm so familiar with that now. And everything has been explained so nicely and deeply in depth that you feel like a part of it. And it gives you a very good familiarity with this. I think hats off to the program and I'm who it is. It's a wonderful thing."

@5:30 - Courtney Fulkerson:
"Right, that's really good feedback. I feel like just knowing that you would feel comfortable once you get into a time where you'd be able to use it. And that's great for sure. My next question was what sort of program were you looking for when you chose CCRPS and were you pleased with the content? I know you kind of touched on that already, but just maybe an overview of what exactly you were looking for, whenever you decided you were going to start looking for a program."

@5:56 - Rabiea:
"All right, so yes, as I told you earlier that I was actually looking for a program that could enhance my understanding on drug safety and being a physician and a pharmacologist as well. As I said earlier, I think it's the most important thing to be aware of the fact or to understand this critical point that public health and specifically individual patient safety is very important. And the reporting and monitoring the adverse events or the side effects, it's crucial for any physician, I suppose. So it's not just that the program is I think not only for those who want to pursue their careers at drug safety position, but it's also very important for anyone who's in health care health system. Because it starts from very basic and digs down deeper. So I think for anyone who wants to have information to a certain level, I think this program is the best platform to, know, learn all of those experiences through it, yeah."

@7:05 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Good, and then is there anything that you would change or that you feel like could have been enhanced to make it a more rewarding learning experience for you?"

@7:15 - Rabiea: "Yeah, all I think that the program is very comprehensive and all the materials are already there. But, you know, I would just suggest that maybe, you know, if there is some place for interaction, something like an interactive session. Okay. Yeah, you know, something that can also help you in terms of job placements, although there is a portion that covers about the job placement program as well, like what roles one can play after completing this course or something. So, but still I would say that a few more interactive webinars or sessions to solve your queries there and then or to have more fruitful discussions. I think that can add more flavor to the program."

@8:04 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah. And we've actually, I've heard that from a few other people, just having like an interactive element so that you're able to maybe put what you've got into action, I guess."

@8:14 - Rabiea: "Yeah, because you know, when you're actually going through the program, you're reading stuff like that, there are few things, you know, that keep on popping in your mind and you want to discuss them and, you know, at certain points. I think that's one thing."

@8:28 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "That would be useful. Okay. Perfect. And well, any feedback is good feedback. So I'm sure that they would love to take that and just for any future learners or if they ever did like a refresher or something for you, then that would be a good additional element to add in there."

@8:55 - Rabiea: "Actually, I'm also doing a certification program at McMaster University for clinical research. I think the good thing about this program was that I was also able to, you know, merge my knowledge between the two courses. And you know, I think if you also include the safety portions of the study protocols, or like the safety sections of investigators brochure, you know, could discuss more on that, I think that will also help, you know, practical experience when you're actually working in the industry, because there are multiple roles that you have to do when you're actually working. So I think maybe that can be a little more initiative program."

@9:49 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah. Okay. That's great. When you were considering enrolling, was there any specific information on our website that could have better highlighted the benefits of the course?"

@10:00 - Rabiea: "Sorry, I didn't get that."

@10:02 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Whenever you were considering enrolling, was there any specific information on our website that maybe could have better highlighted the benefits of the course?"

@10:12 - Rabiea: "No, I think it was pretty much sufficient. And yeah, it was eye-catching. When I opened the website, there was sufficient information over there."

@10:25 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "I could immediately figure out, yes, this is the thing that I'm actually looking for."

@10:30 - Rabiea: "So it was easy to navigate and just... It's easy to navigate, yes. Okay, good."

Olajumoke transitioned from plant biology to clinical research, boosted by a CCRP course that enhanced her job readiness and career progression in clinical research recruitment.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Olajumoke Owati's feedback underscores the effectiveness of the CCRP certification course in providing a solid foundation in clinical research. Her suggestions for including PDF content highlight an opportunity to enhance the course's accessibility and utility. Her positive experience and subsequent career success exemplify the course's potential to significantly impact professional development in clinical research.

Key Takeaways

● Olajumoke appreciated the comprehensive introduction to clinical research provided by the course. The curriculum covered essential topics such as clinical trials, informed consent, patient safety, adverse event reporting, and ethics, which she found fundamental for beginners.

● The video format of the course was engaging and facilitated easy understanding of complex topics.

● The course significantly boosted her confidence, enabling her to secure a job in clinical research. She felt well-prepared to discuss clinical research topics knowledgeably during job interviews.

● Olajumoke highly recommends the course for individuals starting a career in clinical research, citing its affordability, comprehensive content, and engaging delivery.

Program Structure:

● Learning about subject recruitment was particularly enlightening for her, providing practical knowledge that directly applied to her job in clinical research recruitment.

Learning Tools:

● The course's affordability and comprehensive beginner-level content were decisive factors in her choice. Olajumoke was transitioning from a background in plant biology to healthcare and was drawn to the structured learning path offered by CCRP.

@0:01 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Well, sorry about the technology issues, but I'm glad that I have you here and congrats on successfully completing your CCRPS program. And of course, thank you for taking time to meet with me. We're pretty much just going to go through a quick question and answer style conversation. And then once you're ready, we'll just go ahead and start going through this."

@0:24 - Olajumoke Owati (iPhone): "All right. That's why you're welcome and I'm happy to connect with you too."

@0:29 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Perfect. All right. Could you share some of your favorite moments from the course that enriched your learning experience?"

@0:36 - Olajumoke Owati (iPhone): "Oh, thank you. I learned about fundamental clinical research, clinical trials and responsibilities, informed consent and patient safety, adverse events reporting and responsibilities. I have to learn about ethical research in vulnerable populations, management, data handling, record retention, subject retention, compliance. What's my favorite moment is learning about recruiting subjects in clinical research."

@1:12 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Awesome. What sort of program were you looking for when you decided to choose CCRPS, and were you pleased with the content of the course once you got started in the program?"

@1:22 - Olajumoke Owati (iPhone): "I was looking for a beginner course in clinical research, and I was pleased with the content immediately. Expected, because when I was in my master's of public health, clinical research stood out to me, and I was so happy to learn more about clinical research after reading about the TOS-KIGI experiment, which was unethical then. And I was like, okay, I would like to concentrate in clinical research, then I went online to look at the cost. I can do the certification I can do and I came across the Advanced clinical trial course at CCRP has and I looked at the content and I saw that that was exactly what I was looking for. Yeah, I'm glad that that fit for you and hopefully you enjoyed your experience. I'm looking back."

@2:22 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Is there any aspect of the course that you feel could have been enhanced to make the learning experience even more rewarding?"

@2:29 - Olajumoke Owati (iPhone): "Yeah, all the aspects of the course honestly because it's self-paced is video. You can play back here again. I am just wondering if the video content can be available to us as a PDF document. Because some learners love to read too instead of watching the videos only. This can be available at an additional cost if possible or should be provided after obtaining the certificates. So, maybe after completing the program, if you want to have the PDF for the whole content as the reference material, that can be made up of legal."

@3:12 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Okay, that's good feedback and I'm sure that they will take that back and that would definitely benefit any graduate of the course for sure, just that they would have that reference."

@3:30 - Olajumoke Owati (iPhone): "None then, because I was looking for a beginner course in clinical trial and that all the elements I need as a beginner has been included in the course. So as a beginner, the course is very sufficient."

@3:45 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "That's really good to hear. When you were considering enrolling, was there any specific information on our website that could have better highlighted the benefits of the course?"

@3:56 - Olajumoke Owati (iPhone): "Okay, when I was considering enrolling. Honestly, immediately I did the intro because I know there was an introduction that you can sample the course to see if it fits for you. I was chilled and everything works well for me then and that was why I enrolled."

@4:18 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Okay. That makes sense. I'm glad it fit for you. Would you consider revisiting the course for a refresher?"

@4:27 - Olajumoke Owati (iPhone): "And is there any specific information that you'd want to see within a refresher course? Yes. I always revisit the course when I started my career in clinical research to better understand how to consent participant in clinical research."

@4:44 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Okay. Perfect. And if someone from our program were to ask you for recommendations for future editions such as the 2025 edition coming up, would you be open to sharing a list of recommendations and potentially being featured as a course contributor for that edition?"

@5:00 - Olajumoke Owati (iPhone): "Yes, I will."

@5:01 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Okay. If someone would be in touch about that, I don't know when, but somebody at some point will be in touch with you. Just because recommendations are good and obviously if they use them, then they would want to give you that credit."

@5:17 - Olajumoke Owati (iPhone): "Could you share what factors motivated you to choose this course and how it stood out from other options that you might have considered?"

@5:52 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "And did you explore other offerings whenever you were deciding you'd look to other ones?"

@6:00 - Olajumoke Owati (iPhone): "Yes, yes, I was like three to four. So when I was comparing the prices, the costs rather, the cost was cheaper, was the cheapest. Yeah. the content was all I needed, and very affordable and comprehensive, so."

@6:20 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Okay, perfect. And can you share about your professional journey prior to embarking on this course and how you envisioned the course would contribute to your career growth?"

@6:31 - Olajumoke Owati (iPhone): "Thank you for that question, that's a very comprehensive question. I used to be a plant science biologist back in Nigeria before looking into the United States of America. And I've always wanted a career in human health care profession, and I saw this opportunity as a new beginning because I've always been in plants and I want to transition to human science. So I decided to take some anatomy if you feel like. and medical technology courses at the Montana State University, where I got a certificate in medical assistance. And after graduating from the school, my quest for knowledge and eagerness to contribute to research in human and making impact made me enrolled for a master's program in public health at the Concordia University of Nebraska. even already had master's of science in plant pathology back in Nigeria. So part of the course if I took where Hall was about clinical research, like because Piggy, I stayed here home and I did about statistics, which talk about patients retention, and how to calculate the statistical analysis and clinical research. And I got interested in the field. So before completing my NPH, they're in high-class and looking for a certification course soon. and my knowledge and launched me into the industry and I came across the advanced clinical trial system certification course which enhanced my knowledge and I started applying for jobs in clinical research even before I completed my masters of public health so I already had the certification after I came across that I did the certification within three weeks and I added that to my resume. Fortunately for me I got the job at a legal health research as the patient engagement associate and that is all about clinical research recruitment where I recruit the right subjects for different studies so that was how I started my career in clinical research and the first question I was asked was do you have a study so that I added the certification from your complaint and I was asked to talk"

@9:00 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "for them about it."

@9:01 - Olajumoke Owati (iPhone): "So I was able to tell the interviewer everything about the little child in a realistic way and she was very impressed by my education too. I got the job."

@9:15 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah, that's amazing that it got you to the position that you're in now and it seems like you're liking your career so far. So I'm glad to do that in some way. And you said it took you three weeks to complete the course."

@9:29 - Olajumoke Owati (iPhone): "Yes, yes, it took me to get some intensive study. Yes, the character was so determined to finish the certification on time and started career before I completed my master's of public health so that by the time I completed my master's of public health I will have a job in clinical research then I can grow in my career."

@9:55 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Okay, yeah, that's awesome. And then after master's How did you update your resume to reflect the skills and knowledge that it gave you and how did it enhance your professional profile?"

@10:08 - Olajumoke Owati (iPhone): "Yeah, I included all the information I acquired, coupled with the experience I have in healthcare and the certification enhance my chances of getting a job because interview about my knowledge of the cost. all I did was I have some specifications before Six Sigma quality management, certification, too. I just added the advanced clinical trial, assistant certification, and that was number one because I was looking for a clinical research job, so that was number one and I added skills and also the confidence I learned in the cost."

@10:49 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Good. I'm glad that it made you confident and it definitely made you stand out as a candidate. I'm sure for recruiters and getting that next job. How would you describe your experience with our learning platform and did it facilitate a smooth and engaging learning process?"

@11:06 - Olajumoke Owati (iPhone): "Yeah, the experience is very fantastic because like I said earlier home, it's video and you can always pause playback to know to hear again and assimilate the information. The whole thing I would like them to have is the PDF format because sometimes you may not just be in the mood to listen to videos but I know that the video is very engaging you have to sit down, listen, write and also there were case studies so the learning experience was fantastic for me and it was smooth and the platform too is there were no glitches so that's a smooth layer."

@11:50 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "That's good to know. Can you share how the course boosted your confidence and prepared you for your job interview or career-advancing clinical research?"

@12:00 - Olajumoke Owati (iPhone): "Yeah, so because we said my confidence because like I said, Helia Horne online, it's just like a comprehensive course to bring everything together. So the course I said from introduction to clinical research, clinical trial management, data collection and form consensus, patient recruitment, the history of clinical research. So I was able to see everything as a story, like it's storytelling. So I was confident when I started interviewing, I was being asked some questions and there were case studies during the course. So I could apply the case studies and also the ones I learned during my masters of public health. So I think that was what got to my interviewer."

@12:56 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah."

@12:58 - Olajumoke Owati (iPhone): "Yeah."

@13:00 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Good. And what part did you find most engaging and beneficial to your professional development?"

@13:05 - Olajumoke Owati (iPhone): "And the part I love most is the clinical research recruitment because I said, okay, so it is not just HR, EMR resources and recruits. recruiting, I was kind of confused in the first place that how we hire them both. After doing the course, I realized that, no, we are not hiring them, but we are recruiting volunteers. so that was what stood out to me because I was initially confused that way. Fine, we are paying them, we are not paying them for what they do, we are just competing, fitting them for their time and their willingness to add to research. So that was what stood out to me and also I was like, okay, if I am into recruiting, I will be engaging with people, talking to different type of people. I love."

@14:00 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "So that was what it's And then that's what you are okay now so that it worked out perfect. What are some reasons that you would recommend this course to others based on your experience?"

@14:12 - Olajumoke Owati (iPhone): "I'm going to recommend this course to others if you want to start your career in clinical research this is a very good course for you number one it's affordable number two it's self-explanatory and it's engaging so and it has everything you need to part your career in clinical research and the course has really helped me and I can make reference to the course if I was to remember one or two things I can always go back to the course and course it's accessible for a lifetime so it's a good investment yeah I think that that part is important just if you ever need to go back it's there for you."

@15:01 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "And last question, can you share how your career has advanced since you completed the course?"

@15:06 - Olajumoke Owati (iPhone): "Yeah. Thank you. started as a patient engagement, how to sit at, illegal health research, and over time I started, and this is 24, started in I still work there, but I have another opportunity here at San Maron CPC, so the illegal health research was a remote position, I still work at the PRR now, so because I changed my place of work, I got another place, which is San Maron CPC that is an onsite position, because after completing the course I started a remote position, but I wanted to come onsite to see those like source documents, screening laws, engage with participants, do the trial additional now informed consent, not just the calling participants. I engage now in telehealth. I do other things in recruitment and it advanced my career. I came on site. started as an outpatient service coordinator where I do the administrative part of recruitment and house. The clinical aspect like taking vital signs, doing EKGs, accusing, and now I am implemented as a clinical recruitment administrative coordinator whereby I package all the advertising materials for higher distribution, which I think it's a big one because before any studies that I already have the information, I package the advertising material by our distribution after that. I design the posters, the flyers, the key to practice the plan and also I do the clinical aspect so it's like a promotion within two years my career has advanced under which is a good one."

@17:13 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah that's amazing and best of luck to you in your promotion and I know you'll be perfect for the job and it seems like you're really passionate about the whole research so I think that they'll be lucky to have you there for sure. That's the end of our interview and I thank you for your time and just sharing your experience with our platform and your input will definitely be beneficial to future learners that are going to take this course so I really appreciate you and like I said I wish you the best of luck you'll get an email from me or from it's from giftagram is where you'll send your gift card here in a bit but that completes our interview."

@17:57 - Olajumoke Owati (iPhone): "Thank you so much."

@17:59 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "All right. Have a great rest of your day. And you too. Bye. Bye-bye. Yeah."

Vinil Transitioned From Overseas PV Roles To North American Market Success After Gaining Crucial Regulatory Knowledge Through The CCRP Course.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Vinil's feedback highlights the CCRP certification program's effectiveness in providing comprehensive education in pharmacovigilance and clinical research, tailored to the needs of professionals transitioning to the North American healthcare sector. His successful application of course learnings in securing employment underscores the practical value of the program. Vinil's suggestions for including more regulatory comparison could help further tailor the course for international professionals.

Key Takeaways

● Vinil appreciated the broad understanding of pharmacovigilance (PV) and clinical research that the course provided. It helped him connect his previous truncated job roles into a coherent whole.

● The course content was instrumental in helping Vinil transition to the North American job market, particularly with knowledge about PV processes in North America.

● The course content directly contributed to Vinil securing his current role, allowing him to effectively discuss industry standards and processes during job interviews.

● Vinil valued the self-paced, online format of the course, which was crucial for managing his schedule as a newcomer to Canada.

● Vinil would recommend the course to others, especially those new to North America or transitioning roles, due to the course’s comprehensive content and flexible format.

Favorite Course Elements:

● Learning the end-to-end PV process was particularly enlightening for Vinil. He enjoyed how the course detailed each step of the process, which enhanced his understanding of his role in the broader industry context.

Content Satisfaction:

● The course met Vinil’s needs perfectly by providing detailed guidelines and regulations for FDA and Health Canada submissions, which were crucial for his career transition in North America.

Website and Support:

● The website was user-friendly and informative. Vinil utilized the chat feature to get immediate answers to his questions, enhancing his enrollment experience.

@0:00 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Meeting is being recorded. Once again, thank you for meeting with me today, and it's a delight to have you here. Congrats on completing the CCRPS program, and I'm pretty much just going to go through question and answer a soft conversation, just to hear your feedback and your experience with the program. So, once you're ready, get into it."

@0:20 - Vinil: "Yeah, sure."

@0:22 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Perfect. Could you share some of your favorite moments from the course that enrich your learning experience?"

@0:28 - Vinil: "Yeah. So, I did work at a PV level, you know, at my previous organization, but then it was always truncated. The information given to us was always limited to the job at hand. So, I was initially in triage. I was a researcher first, and then I was in triage, and then I was in with the ICSRs and individual case safety processing. But the course really helped broaden my view on all that was going on. Yeah, I got to find out what happens, you know, after a case is processed, you know, how it helps in signal detection and how it, you know, participates in generating a signal and the safety limits and how it goes on into the PSERs and PADERs. Because this information was always, you know, it was always on the need to know basis, you know, when you work within a team, when you work with other doctors and whatever it's always also this happens there and this goes on this way. But then with the course, everything was so structured. So I got to see, you know, where my role comes in as a PV professional, as somebody dealing with whatever adverse event and it gave me a very nice perspective start to finish on what happens. I was very thrilled with that."

@1:42 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah, good. So it gave you a more, I guess, broad and full circle of how everything is working together. That's good to hear. What sort of program were you looking for when you chose CCRPS and were you pleased with the content of the course once you got started?"

@2:00 - Vinil: "So, the CCRPS was exactly what I was looking for because I moved countries recently, and previously I was back home in my home country of India, where things work a little differently over there. When I first came, I moved to Canada two years ago. I wanted to have an idea of how the North American markets work, what they look like, what they expect from an interviewee. So, the program with the CCRPS really gave me an idea, especially with regards to submission guidelines, what submission timelines are with regards to Health Canada, it is with regards to the FDA, so this is exactly what I was looking for. I was looking to find my footing in sort of the PV scope in this part of the world, and it was exactly what I wanted. It gave me a very nice understanding of how things are done, and I was very informed once the course was done."

@2:58 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah, that's a really good thing. Is there any aspect of the course that you feel could have enhanced the learning experience to be more rewarding?"

@3:07 - Vinil: "I don't know if I can honestly answer that question because, again, coming from a research background, I had an idea of most of the things, but then I never knew where it fit on the grand scale of things. Because, again, when you work with a corporation, your role is always truncated, and your role is always directed towards what you're doing, whatever task is assigned on your hand, that's what you focus on. So the course really opened things up, so I don't know if there's anything more that I would have wanted from the course itself."

@3:41 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "I don't know if that's the answer you're looking for. No, I think anything that you're Yeah, because I got a very broad perspective on, so because there were lot of case studies as well."

@3:52 - Vinil: "Remember, towards the end, know, they had case studies, it was very informative, so I don't know what I would want more. Yeah, I don't think I can answer that question up because I don't allow out of it. So I don't know about my question too. And so that maybe in a few years to come, I should be able to answer that."

@4:09 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah, well, good. I feel like even if, I mean, if you were saying that you had everything that you needed, then I feel like that's still good feedback. Absolutely. Or if they're looking to add anything, maybe it's already where it should be. So, always good. Were there any additional topics or elements that you wish were included that could have further elevated your understanding?"

@4:33 - Vinil: "So, the course was very, you know, very uniquely structured and that it started with the history of pharmacovigilance and it went into what kind of jobs we can look at and what roles are and, you know, and what are the median lines for what we ought to do. So it was very well structured that way. I think, and again, I wasn't professional. I just that I wasn't aware of how it occurred, just part of the world. I guess. maybe some sort of some sort of a bridging program where they helped you know just especially from participants who are coming from different countries because we we have different supervision guidelines in different countries like so if it could maybe bridge the gap between what we I know it's kind of a you know broad range just to zoom okay these are the kind of students we're going to have but if something if it could bridge between you know the FDA and and have Canada and whatever we did you know probably make the process a lot more I guess streamline in that sense as in so I would know okay with regards to the Indian submission this is what I did and this is what you know I have to do with regards to the FDA submission these are the reporting timelines these are the reporting failures so maybe that alone I guess okay so more of like a global um yeah you know because I mean at least from most of the reviews when I read I mean a lot of them were were agents who had previously worked in you know out of APOC So it definitely will suit, you know, once you target it towards a global audience, I think it definitely would help, yeah."

@6:09 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Okay, perfect. And when you were considering enrolling, was there any specific information on the website that could have better highlighted the benefits of the course?"

@6:21 - Vinil: "No, I think, I mean, I just read a lot of the testimonials, I read a lot of the And yeah, I was really happy because I was looking at a few other programs. was looking at a few universities where they did the exact, you know, I mean, that's what they said that they would do. And no, I got, I got all the information from the website. And I was able to speak to somebody, you know, on the, on the chat. And I was, I got a few questions. wanted to know how they would go about doing this. And yeah, I was, I had all my, all my questions answered. So no, I found the website very, very convenient to use and very informative. I was able to make a decision. And I think, I think the Third day after I looked up on the website, I joined."

@7:03 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "was like, okay, no, I'm game. Yeah, that's great. Would you consider revisiting the course for a refresher? And is there anything that you would want to see within a refresher course?"

@7:16 - Vinil: "Yeah, that is interesting. Yes, I would consider revisiting the course. I already have some of the PDFs was originally offered as well, but especially with regards to progressing and moving forward, moving from just your individual case, if you're processing to moving towards different roles to help with working and offering payders or PSURs, if anything is available on that sort, yeah, would definitely want to revisit the course again, if I can get a little more information on that. Because what I did as well, you know, when I was interviewing and once I was done with CCRPS, This is what I said on my interviews is that, you know, though I have not been technically trained on these things, I'm aware of these things because of the second program I got to CCIP, yes. I did mention it on every interview. So and I'm also, I think my last interview, the hiring manager said, okay, I'm glad that you know these things. So it's going to be easier when you hit the ground running."

@8:21 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "So in that sense, yeah. Good, good. I feel like it did give you a good broad, I guess understanding of everything. then you'll be able to apply that to wherever. Okay, if someone from our program were to ask you for recommendations for future editions, such as the 2025 one that is upcoming, would you be open to sharing a list of recommendations?"

@8:48 - Vinil: "Yes, yeah, absolutely."

@8:51 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Okay, someone would be in touch about that. And then that would, if they were to use it, then you would be considered like a contributor to that edition set. It's not as sure comfortable with that, perfect. Could you share what factors motivated you to choose this course and how it set out from other options that you might have considered?"

@9:10 - Vinil: "Yeah, sure. So the first thing, I think, as opposed to any other regular university, like a physical address, I was very glad that CZF was available for me to do online, offline, not to demanding because I was, like I said, I was a newcomer, so I was between jobs and between interviews and just handling things on the domestic level, and I was a newcomer to the country as well, right? So, so many things. I was just happy that the program was accessible, I got all the source material, I got the individual quizzes that I had to do, I was given a deadline for that, and I had enough time to prepare to study up and to, you know, to make myself sure that, okay, these are the things that I know. This is what I'm going to do. It was very accessible that way. So for somebody who is busy and for somebody who wants to upscale and he was busy working and wants to learn more, this is the perfect course because when I looked at many other universities, local colleges as well, it was too much of an ordeal. Like it was okay, you have to be seven hours, you have to be here, you have to go talk to this person and do that. So the fact that it made everything approachable was definitely a huge feather and it was a huge benefit. that the structure was very, very reasonable as opposed to a lot of the local colleges, even university, local colleges over here. That was another thing that I was very grateful for. just charged it to my card and did like I think a four-month installment."

@10:51 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "was really happy. Yeah."

@10:52 - Vinil: "It just meets all the criteria."

@10:54 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "it's all of your boxes and that's perfect. That's perfect. Could you share about your professional journey prior to embarking on the course and how you envisioned the course would contribute to your career prep?"

@11:08 - Vinil: "Yeah, so like I said before, I was completely unaware from a North American, from how PV was being directed and how it was working. So I'm so glad that once I was done with the course, I was able to apply for, because the course also towards the end starts giving you ideas and what kind of roles you can apply for and what kind of qualifications you need and gives you an idea of how to use those words. So I did use lot of those words, I did use a lot of those terminologies. And so when I was just applying, it was not just willing, I was not just applying to anything I could find. I was looking for specific roles, coordinator roles or roles that involved analyzing and processing information. So that was very beneficial that I got out of the information that was given towards the end of the course. So that was a big help and what. What it also gave me was so when when I was interviewing with a lot of the managers when I this is what I said the verbatim Well, I have not worked You know with regards to health Canada submissions or the FDA submissions. This is what I gather. These are the this is the information that I've gathered This is what I know of what happens Yeah, these are the kind of these are your submission protocols These are these are the submission timelines and I've gathered this because of the course that I did so It worked, you know on a two-prong level in the fact that I knew these things and In the in the interim, you know, as I said mood or whatever. I was not just sitting, you know sitting idly I was doing certification So that really helped and I got called back by the same manager for two different interviews because of that Okay, yeah about 30 people who interviewed but because of that I was called back for the second time I don't you know, my the hiring manager remember me and said I remember you You know, you mentioned on the first interview and then can you speak more to that now? I did. And yeah, that's the job that I'm working on right now."

@13:03 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "So that's really good to hear."

@13:05 - Vinil: "Yeah, absolutely."

@13:06 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah, you were able to apply it and it got you the job, it sounds like."

@13:10 - Vinil: "So that's that's awesome. Yeah, it was a wait, but, you know, for the same manager to have called me back like two months later and to interview me again was, you know, something had to stand out. And the fact that I said, you know, as much as I'm a newcomer and I've never worked, you know, this front, this is my knowledge of of such and certain that I got this from the court and certification that I did."

@13:32 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "So yeah, weapons using. Yeah. About how long did it take you to complete the course to absorb the knowledge? And then do you feel like the duration was adequate for your learning?"

@13:45 - Vinil: "Yeah, that's a good question. So because I am from, you know, research in a PV background, I had, you know, idea of most of the things. So I think I spend a total of, I guess, 10 days, okay, just me studying and going through it. I mean, if you're really going to be taking your time, it should probably be two to three weeks or maybe a month, because I already had a working idea of most of these things. I was able to, you know, accelerate and go through the course material. And because, you know, I have this, I knew what the CTCA was, and I knew what the scoring was like. So I was able to move through quite quickly. I mean, I took about 10 days and that was, and again, like I said, I was managing, I was bouncing between two jobs and taking care of things on a messy front. 10 days was, was, was very comfortable for me to work with. So yeah, I definitely said, so if somebody is from, from a COVID as a background, or from a clinical research background, maybe two weeks is that is a good enough time to go through the material and to get as much as you can out of it."

@14:46 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Right. And the fact that it's self-paced, I feel like helps to just figure schedule and you're able to use as much time as you want to there."

@14:54 - Vinil: "So that's, yeah, absolutely."

@14:57 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "All right. After completing the course, how did do you update your resume to reflect your newfound skills and knowledge and how has it enhanced your professional profile?"

@15:07 - Vinil: "Well, first and foremost, I made everyone know that the identification was completed. I put it up on LinkedIn and that was one of the first things that I did to show them that, you know, within the time that I had these are the these are some of the things that I did. And I also started altering my resume and my CV to let them know that, you know, besides whatever responsibilities and duties that I had, my my general knowledge of certain such things, you know, again, like I said, you know, the submissions or whatever was was up to date because of the, you know, certification that I did, I had hands on access to most of the databases, the safety databases back home. But that was, you know, the chink in my armor, the fact that I was not aware of certain things. So on the horizon, I've mentioned, you know, after the certifications that this is the general, you know, knowledge of things that I've gathered over the period of time, and that I had. which was because of course so that's how I put it on my resume and even on my telephonic interviews and my live interviews that's what I said."

@16:08 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah that's awesome I feel like you really you've had a good experience at that for sure."

@16:12 - Vinil: "Yeah and it also helped because I'm technically not in a health care professional you know I'm not I'm not from a head CP background I'm from a research background so I've been one of my interviews when you know I was asked point you know point blank do you think you can serve you know because you're not from a health care professional background but you think you can serve at this level and these are some of the answers that I give that you know it's because of x y and z and then because of my knowledge of this this and this is that I'm confident that I'll be able to serve so I was able to say all of that because of what I've gathered and what I gleaned."

@16:44 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "that's amazing it definitely helped with your transition into the field."

@16:49 - Vinil: "Yeah how would you describe your experience with our learning platform and did it facilitate a smooth and engaging learning process? Absolutely the platform is so was very easy was very easy to navigate and to go through it was not with the UI was amazing and you know the PDF forms it was it was downloadable so I could read so sometimes what I do is I download a few of the PDFs and I would take it on my phone and if I had long bus journeys I would just sit on the bus and just go through some material like driving up to an interview or back so it was very I should say it was very open it was very user friendly and the point of the course was not to stun inflammation or to keep it protected or just cover it up which unfortunately most of you know when you work at major organizations it's everything in document controlled and it's only on a need to know basis so this was very in that sense so yeah it was very very accessible accessible is is the accessible and user friendly that would bring up yeah awesome I know you kind of touched on this but can you share how the course boosted your confidence

prepared you for job interviews and career advancements in clinical research? Yeah, so I mean, I felt like I got new shoes on, you know, once the course was done.

Okay, I found my footing. This is exactly, you know, this is to bridge the gap between my overseas experience from back home and what I can offer any company that would hire me.

So at this point, I'm working with a patient support service system. So because of my understanding of, okay, these are the regulations and the guidelines for FDA or Canada, I was able to do really well on my interview, you know, with our prior experience in this country, I was able to go and convince my interview managers and the powers that be that I'm a good fit for them.

And yeah, I think it's going to be a year with this company. And I think I got the job.

Let's see, I was done this is your piece in the month of September or October. and it was about four months after that.

yeah, it's been a great 14 years."

@19:04 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah, yeah, that's amazing. I feel like it really did. It helped you. It definitely boosted your confidence. And I feel like you were well prepared for your next role for sure."

@19:15 - Vinil: "Yeah, yes, I was."

@19:16 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "What part of the course did you find most engaging and beneficial to your professional development?"

@19:23 - Vinil: "Well, with regards to upskilling, you know, you know, just just the amount of information with with the painters and PSURs and how the safety information that is being collated and collected by different teams, how that goes into just the overall, the life cycle and history of a drug, know, mean, post marketing surveillance, that was the big picture for me. And hopefully I want to get into that role as well, because I've done my due diligence and I've done my put in the hours with everything else, know, started with three hours and everything else. And so now I feel like because I'm a of that, you know, more than just the terminology or what I'm aware of what goes on there. So I'm hoping that I can upskill myself, you know, and start contributing to the overall life cycle of, you know, the safety profile of the drug, now volunteering and by working at those levels. yeah, that's something that I got very clearly from the program. It was not just hearsay or listen a few medics talk about, okay, or that, you know, whenever you're going to submit that. So it was very interesting in that way. So now that I know what kind of role it is and what it entails, and I know what more is needed from me, I feel like I have a better chance of getting it at this point."

@20:42 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah, for sure. feel like it gave you just some interest in something that you maybe didn't know before. Okay, last question that I have for you. What are some reasons that you would recommend this course to others based on your experience?"

@20:57 - Vinil: "Well, because it made my interview process. is a lot more interesting in that I didn't have in that I now had a lot more resource material with me. So I think I would recommend this especially for newcomers who come from Asia-Pacific background and you know when we're not aware of certain nomenclature and certain guidelines that are swallowed and this part of the world. I would recommend that to anyone and everyone who comes there. Even if you do have a pharmacologist's background or research background or whatever it is you in clinical set I would definitely recommend this program just to make sure that you have enough in your quiver so that you can really do well on your interviews and it brings you up to speed when you start fresh as well."

@21:45 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah okay well that was great I feel like you had a great experience with the program and I can definitely tell just that it's helped you get where you are now and I feel like you had a great success story with it. So I really appreciate your time that you took to spend with me. today and just go through some of those questions. And I know your input and just your experience will definitely have an effect on future learners that are in the program. So I really appreciate you. And I wish you the best of luck in your career. I feel like you have a great understanding of clinical research and it's definitely going to be, you'll have a great career from here on out."

@22:21 - Vinil: "Thank you so much for being here."

@22:22 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "All right, thank you for the program as well, yeah. Yeah, well, I will send you an email. You'll get an email by saying with a gift card for doing this and spending time with me. But for that, we are pretty much all set. So I really appreciate you and I hope you have a great day. Thank you, you too. All right, thank you, bye bye."

Rose Hyson Transitioned From Educational Research to Clinical Trials Project Management, Enhancing Study Compliance and Management Skills Through the CCRP Course.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Rose Hyson's feedback underscoring the CCRP certification program's effectiveness in delivering comprehensive, flexible, and applicable education in clinical research management. Her experience highlights the program's utility in real-world applications, such as preparing for audits and enhancing trial management. Suggestions for more interactive content and additional focus areas suggest avenues for further enrichment of the course to cater to a broader range of professionals within the clinical research field.

Key Takeaways

● Rose found the PowerPoint slides provided during the course exceptionally useful for reference, especially useful when revisiting content for practical application.

● The section on master trial files was particularly valuable for Rose. She applied this knowledge during an audit she faced shortly after completing the course, significantly aiding in her preparedness and response.

● While Rose appreciated the self-paced nature of the course due to its flexibility, she noted the experience felt isolating at times. She suggested that incorporating more interactive videos could enhance engagement and diminish the sense of isolation.

● The content on trial processes and paperwork was highly relevant and applicable across various trial types, proving beneficial in her role.

● Rose would recommend the course to individuals transitioning into clinical research manager roles due to the foundational knowledge it provides.

Content Satisfaction:

● Coming from a non-clinical trial background, Rose valued the comprehensive introduction to clinical trials, which helped bridge her knowledge gap as a new clinical trials project manager.

Learning Platform:

● Rose found the platform easy to use and appreciated the availability of materials for download, which facilitated her learning during commutes.

@0:00 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
This meeting is being recorded. Right, well, it's a pleasure to have you here, and congrats on completing the CCRPS program. Thank you for taking the time to meet with me.

@0:11 - Rose Hyson (Hennepin Healthcare):
We're pretty much just gonna go through a question and answer style conversation, and just get your input and your experience with the program, and then once you're ready, we'll go ahead and get started.

@0:22 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
All right. Could you share some of your favorite moments from the course that enriched your learning experience?

@0:32 - Rose Hyson (Hennepin Healthcare):
So I think a lot of the PowerPoints ended up being really useful, and I've gone back and looked at them over and over again. Initially, during the learning process, it might not have seemed like a highlight, but in the end, they've been very beneficial to me.

@0:56 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
Okay, good. It’s always good to know that you can go back and look at the materials when needed. What sort of program were you looking for when you chose CCRPS, and were you pleased with the content of the course once you got started?

@1:13 - Rose Hyson (Hennepin Healthcare):
I'm a clinical trials project manager and came from an educational background, so I had a lot to learn specifically about clinical trials. There was some repetition from other HIPAA and city training, but the section about the master trial files was most crucial for me. It was the most important part for me, especially since I was audited right after I took this course. It was very beneficial as I could immediately apply what I learned.

@1:57 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
Master trial files?

@1:59 - Rose Hyson (Hennepin Healthcare):
Yes, that really was the most important part for me. There was a lot of new learning there, and I was able to apply it directly during an audit, which was extremely helpful.

@3:05 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
That’s great to hear, especially that you could use the information right away. Looking back, is there any aspect of the course that you feel could have been enhanced to make the learning experience more rewarding?

@3:38 - Rose Hyson (Hennepin Healthcare):
For me, having the course be self-paced was important but it also felt a bit isolating at times. I was never sure if there were other people behind the program.

@4:08 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS):
Okay, that’s valuable feedback. Were there any additional topics or elements you wish were included that could have elevated your understanding of clinical research?

@4:31 - Rose Hyson (Hennepin Healthcare):
Since all of our clinical trials are behavioral rather than pharmaceutical, including a bit on behavioral trials would be nice, even though I know that’s a rare group compared to other clinical project managers.

@6:00 - Rose Hyson (Hennepin Healthcare):
This course was more approachable and affordable than others I considered. It was important that it was flexible and could be done on my own time.

@7:05 - Rose Hyson (Hennepin Healthcare):
I jumped right into being a clinical trials project manager without much prior experience. This course helped me bridge the knowledge gap I had in clinical trial management, which was incredibly beneficial.

@8:38 - Rose Hyson (Hennepin Healthcare):
That's a good idea. I haven't updated my resume yet to reflect the skills and knowledge I've gained from this course.

@11:00 - Rose Hyson (Hennepin Healthcare):
The most engaging and beneficial part of the course for me was about what you should have in terms of paperwork, which is true for both behavioral trials and other types of trials.

@12:38 - Rose Hyson (Hennepin Healthcare):
The course allowed me to manage our studies more effectively. They are now going strong and are compliant, so I won't need to be nervous if audited again.

Ossai Opene: From Process Safety Expert to Clinical Research Novice, Gaining Confidence and Direction with CCRPS Certification

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Ossai Opene’s feedback highlights the effectiveness of the CCRPS certification program in providing a comprehensive educational experience tailored to individuals transitioning into clinical research. His suggestions for course improvement focus on optimizing content organization and exam processes to enhance educational outcomes for all participants. His positive experience reflects the program’s capacity to equip newcomers with the confidence and knowledge required for a successful career in clinical research.

Key Takeaways

● Ossai appreciated the straightforward, easy-to-follow video presentations and found the sample questions at the end of each module particularly useful for reinforcing learning.

● He suggested that restructuring the course to group related topics together, such as inspections and audits, would improve logical flow and learning efficiency.

● Ossai recommended generating new, random questions for each exam attempt to ensure a robust testing experience, enhancing the learning outcome.

● He found the roles and connections between CROs and CPIs most engaging and informative, providing clear insights into the clinical research operation landscape.

● Ossai would recommend the course based on the quality of materials, self-paced format, and positive testimonials from other learners.

● Although new to the field, the course significantly boosted Ossai’s confidence and knowledge, preparing him for potential roles in clinical research.

Course Completion Time:

● Ossai completed the course in one week, leveraging his prior experience in process safety and auditing, which allowed him to progress quickly through familiar content.

Learning Platform Experience:

● He praised the platform for its smooth functionality and engaging format, which included helpful downloads and knowledge checks.

@0:19 - Courtney Fulkerson (CCRPS): "All right. Could you share some of your favorite moments from the course that enrich your learning experience?"

@0:25 - Ossai Opene: "Oh, well, I was thinking in terms of the presentation, the videos were quite very helpful. They were straight to the points and quite easy to follow. I did take some notes, but yeah, they were quite easy to follow. Then at the end of each model, those I had like some sample questions to go through. That's a test. said acquisition of knowledge."

@0:59 - Ossai Opene: "They also. Yeah. they have to just stimulate someone to go back and advance what I've learned or just move forward."

@1:33 - Ossai Opene: "Yeah, it took a while though. I mean, I was just searching how to get into the clinical research space because I'm looking for something I could maybe work remotely as it gets me be. And then CCRPS came to mind. So, I'm looking around pretty nice to my personality and what I want to achieve. And then each time I research, you know, your organization pops up at the top."

@2:42 - Courtney Fulkerson (CCRPS): "Yeah, and you liked everything that was within the content of the course?"

@2:47 - Ossai Opene: "Yes, everything. there are some that but were pretty easy to kind of go through because of my background. Before now, I'm taking a class in design and implementation of clinical trials from John Hopkins University. That was also pretty helpful when I saw that module in the past year of course. I said, okay, that's fine."

@3:14 - Ossai Opene: "So then when it comes to inspections and audits, I'm already familiar with the, I would say with ingredients, but the application of the clinical research is different, but the same methodology. it was easy to also fall out as well. So overall, it was a good experience for me to go through the program."

@6:14 - Ossai Opene: "Hi, no, it was pretty robust."

@7:05 - Ossai Opene: "Oh, I can't think of any, because I did have conversations with your folks online, and so it's planning to lose about three to four months, and that helped me to make up my mind to take the class with you, with your organization."

@8:00 - Ossai Opene: "Ah, I would definitely go to those programs again because I'm not, I'm not actively seeking for a job right now, but yes, I like to go through the programs again, but the bot here is I'm not sure how you structure, um, uh, again, from my background."

@20:17 - Ossai Opene: "Oh, I was everything. Then I would say more in the meat. The meat is the rule of the CRO, CRO, CPIs and how they eat and connect."

@21:00 - Ossai Opene: "Experience. I will say quality of delivery, quality of the materials. will say the fact that is is online and you take that your own pace so some folks are busy walking so they don't have any time in world to sit down in classroom and go through this."

@22:22 - Courtney Fulkerson (CCRPS): "Good. And I feel like your confidence just in the area has definitely grown and hopefully it will take you into your next position."

Clinical Research Coordinator Certification Case Study Featuring February 2024 Cohort Graduate Lisa-Pierre

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share our second graduate case study interview from Lisa, a recent graduate of our CRC certification program.

Key Takeaways

● Lisa-Pierre had a very positive experience with the self-paced online format of the course. She appreciated the flexibility it provided.

● The course gave Lisa-Pierre the clinical research knowledge and confidence she needed to obtain a CRC job right after finishing school.

● Lisa-Pierre felt the course covered all the necessary basics and she did not have any suggestions for additional topics to include.

● The course certificate helped Lisa-Pierre update her resume and get hired at a prestigious research institution.

Impact on Confidence and Employability

● The course certificate boosted Lisa-Pierre’s confidence in applying for CRC jobs despite having no direct US research experience. She believes the certificate was critical in helping her get hired at a top research institution right after finishing school.

Most Valuable Topics

● Lisa-Pierre found the overview of clinical research processes and role of CRCs most valuable. The regulatory topics were important but more difficult.

Recommendations for Others

● Lisa-Pierre would recommend the course to help people get the research knowledge needed for their resume and transition into the field, especially those without research degrees.

Career Advancement

● Completing the course allowed Lisa-Pierre to begin her career as a CRC at Columbia University. She has received other job offers since then.

@0:05 - Courtney: Okay, well thank you for your time and congratulations on you successfully completing the CCRRPS program and taking this time to meet with me and we're pretty much just going to go through a quick question answer conversation pretty much just to prepare the company or future graduates of the program.Okay so can you share some of your favorite moments from the course that enriched your learning experience?

@0:38 - Lisa-Pierre: I think for me what I really liked is that it was self-paced so I started this course I was still in school and I knew that I wanted to get a job like as soon as I finished so I was able to like take my time and then it was tailored to me. I was able to do it at my own pace and go back to the lesson when I was I was unsure about something so that had to get a like what I like the most about the course.

@1:02 - Courtney: Okay, good to hear. What sort of program were you looking for when you chose CCRPS and were you placed at the content once you got started?

@1:11 - Lisa-Pierre: Yes, I was just looking for something to give me more insight on the clinical research coordinater. And I knew little bit about research, but I didn't know about that specific positioning detail. So that gave me a good run-through of what it was about, what I needed to know. And I think I was pretty satisfied with everything I got from the course.

@1:32 - Courtney: Okay, good stuff. Looking back, is there any aspect of the course that you feel like have been enhanced to make it more rewarding?

@1:43 - Lisa-Pierre: Honestly, not really. I feel like I really enjoyed my experience. And I feel like I was able to get assistance when I needed it. I had questions, help. And again, just go back to my lessons.Whenever I wasn't sure about something, so I don't think there's anything I would change from there.

@2:00 - Courtney: of course. Okay. And were there any additional topics or elements that you wish were included within? Basically, just to give you a better understanding of clinical research.

@2:11 - Lisa-Pierre: So I don't think so. I think I covered a lot. Again, I had like a little background on research from school and it went into detail with like regarding other topics that I didn't know about. And now being, I'm currently working as a clinical research coordinator and I feel like I got all the basics I needed. Even when I started the job with the trainings, most of the things that I was being taught in the trainings for the job, not the specific research were doing, I had already seen from the course. So yeah.

@2:42 - Courtney: Well, that's good to hear. When you were considering enrolling, were there any specific information on our website that could have been better highlighted with the benefits of this course for you?

@2:54 - Lisa-Pierre: Um, honestly, it's been a while since I enrolled, but, um, I think for me, like, when I went to look at the course, I just wanted to see, you know, what was included and what I would get from it. And honestly, from what I can remember, I feel like it gave me, like, a pretty detailed information of what it was about and that's what I was looking for. So yeah.

@3:22 - Courtney: Would you consider revisiting the course for a refresher and is there anything specific you'd want to see within a refresher course?

@3:31 - Lisa-Pierre: Yeah. I would definitely go back to it when I first got hired. wasn't scared because it was my first time doing the whole CRC. And I did go back to just have the, like, just have a refresher and just be, be well prepared for my, for my job. I think for me, like, it's a lot about like GCP, I feel like that's something that's really emphasizing. So I'm working in the field, so I...It would be what I would go back to. Yeah, thank you for that input.
@4:52 - Courtney: And then could you share what factors motivated you to choose this course and how it stood out from other options that you may have considered?

@4:59 - Lisa-Pierre: Um, yeah. Oh, I, again, I was in school and I knew that I wanted to work in research, but I didn't exactly like, you know, work in research. When I went on your website, there was a CRC position and that's the one that spoke the most to me because it was, I had it but to me to have like patient facing experience, which is what I was looking for. And again, what mostly attracted me was the self-paced because I didn't want to be subjected to something where I would have to attend classes at a specific time and just be there because I had a lot going on at the time. So that's definitely something that was attractive, like that attracted me to the course. And the other thing is that financially, I think it was a good, it was a good option for like the price and what I was getting compared to others because when I looked at others, a lot of them were more expensive. Well, according to my format, when I compared it to my budget. Yeah. Yeah, that's definitely okay.

@6:02 - Courtney : So you did explore other offers or different programs before. Yes. Mm-hmm then can you share about your professional journey prior to embarking on a course?

@6:13 - Lisa-Pierre: Yeah, so I was in school in Cuba I was a medical student and I wanted to come here to practice. But I knew that like you don't have to pass my exams and I didn't want to have a gap on my CV So I wanted to get into research, but I didn't know how exactly to get into research I didn't want to be doing like just lab work research or just I wanted to have something that was patient-facing why would it gets me to write people and I Think that's that's what led me to deciding to do look into like seriously positions And then I think also when I went on the website like there was a lot of information of what I could do with Um, the certificates, I was like, okay, this seems like something that, um, that's beneficial to me. Um, my prior research experience, it was from full when we had to do papers and everything. So it, I did have experience, but I didn't have any experience here in the state. So. Perfect.

@7:44 - Courtney: Okay. And then after completing the course, how did you update your resume to reflect your new found skills and knowledge and how has it enhanced your professional profile?

@7:53 - Lisa-Pierre: Um, so I just added this, like the certificate on my, um, resume. A lot of jobs I've tried to ask if I had any knowledge of like GCP and they had some other like they had specific things that they asked if I had knowledge on in research and that definitely helped me because I had proof that you know I did a certificate that helped me get the knowledge that I needed for the job. So I feel like that definitely helped me because street out of school with no research experience. think it would have been a bit harder to get a job.

@8:53 - Courtney: Yeah, good. So how would you describe your experience with our learnings?

@9:00 - Lisa-Pierre: Did it facilitate a smooth and engaging learning process? Yeah, it definitely did. I think for me, just had to, hard part was just being consistent because I didn't have anybody to answer to anybody to push me. But I think the learning experience is very nice. It's very detailed. You get, you get all information you need and you get to replay if you didn't understand something. So it's, I think it works because it's, it's, when I compare it to let's say taking classes where you take the clock and that's done, but then you can take the path over and over and over and so you know, you feel like you understand it. And I think that's another thing that I really liked about the program.

@9:45 - Courtney: Yeah, that's a great feedback. Alright, and then can you share how the course boosted your confidence and prepared you for job interviews or career advancements in clinical research?

@9:55 - Lisa-Pierre: Oh, yes. So before I had the sophistication, I knew I wanted to get into research because that would help me on the long haul, but I was scared. I didn't think I was going to find a job because I was a foreign graduate. I didn't have any experience here. I didn't have like the research experience I had was in here and it would be hard, you know, demonstrate like with the guidelines here. It's not the same thing. So I think once I got a tradition, I felt more confident in applying for jobs and saying listen, I had have a certificate. Some of these classes, I know what this is about, I know what research is about, and so I think it definitely boosted my confidence in like just applying for jobs because sometimes I would see jobs and I wouldn't apply for them because I'm like, I'm not going to get it even if I get it, I going to be able to keep up with the pace? So I think that's how it helped me.

@10:47 - Courtney: Yeah, well that is amazing to hear. What part of the course did you find most engaging and beneficial to your professional development?

@10:55 - Lisa-Pierre: With part of the course. Honestly, it's been a while since I've been the course. think what I like the best is like you know when you first start and you tell you about research in general, what it is, phases, how it's healers to patients and what's involved. think when you get into the degree things of like FDA regulations that was a bit you know it's necessary but it was a bit trickier for me. Yeah so yeah.

@11:23 - Courtney: Okay and then what are some reasons that you would recommend this first to others based on your experience?

@11:28 - Lisa-Pierre: I mean one it's a good thing to boost your CV to see how to certificate from an organization that's you know recognized. Another thing is that I believe that you know you get information and you get knowledge that you wouldn't necessarily get if you don't have any research background and then it's always just deep especially people like me who have like financial restrictions, who can go do a whole bachelor's or master's degree. I think That's a good like it's a good bridge in order to be able to get into research. So, yeah.

@12:07 - Courtney: Yeah, that's great. And last, could you share how your career has advanced into completing the course?

@12:14 - Lisa-Pierre: Yes, so I was able to get a job. I was able to get a job in research at Columbia University, which is yeah, which the department is really renowned for their research. And I think had I not had this certification, I wouldn't have been able to get it as such a prestigious university. I've been at the same company. I've even had people reach out to me to for other clinical jobs, clinical research jobs, sorry. So, I think that this is something that definitely helps because that's basically the only, know, official research being that I have.

@13:00 - Courtney: I think that that's all I need from you for now and then if anybody is going to reach out about just future like if they need some feedback or something like that, then they'll definitely do so. All right. Thank you.

@13:41 - Lisa-Pierre: I hope you have a great day. so much, you too.

You can follow Lisa-Pierre’s career story here.

ICH GCP Case Study Featuring February 2024 Cohort Graduate Aastha

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share our second graduate case study interview from Aastha, a recent graduate of our ICH GCP certification program.

Key Takeaways

• The course was very well structured, comprehensive, and easy to understand.

• The pace of the course allowed the learner to fully grasp concepts before moving on.

• The course covers important topics like ethical research and vulnerable populations in-depth.

Topics:

• Favorite aspects of the CCRPS course

• Well-paced, easy to understand, and comprehensive. Allowed time to learn concepts fully.

• Small online community for questions was helpful.

• Very positive overall experience, remembered concepts well.

• Enhancements for the course

• No recommended changes. Appreciated videos, PDFs, quizzes, and self-paced nature.

• Provided for all types of learners.

Additional topics for the course

• Appreciated in-depth coverage of ethical research and vulnerable populations. Surprised this was covered so well.

Website highlights

• Website clearly outlined course contents, process, and enrollment. Easy to find the right certification offered.

• Motivation for choosing the course

• Wanted to enhance clinical research skills and knowledge. This course clearly provided ICH/GCP certification. Liked self-paced convenience.

Aastha (ICH GCP student) and Courtney Fulkerson (clinical research course educator) Transcript - March 20

Duration: 23 mins

@0:08 - Courtney: Well, it’s a delight to have you here and congrats on completing your CCRPS program. And thank you for taking the time to meet with me today. We pretty much are just going to go through a question and answer style conversation just to pretty much get your feedback on the program and kind of give some feedback that we can take into the future graduates if you’re okay with that.

@0:34 - APS: Okay.

@0:34 - Courtney: Could you share some of your favorite moments from the course at and your learning experience?

@0:44 - APS: Yes. So my experience with the [ICH GCP] course overall was just very extremely positive because it was just that at a really good learning pace that allowed me to take my time and just to organize myself in terms of just like learning each concept. So what I really thought was that it was very well structured and comprehensive overall that it just made it easy for me to understand like the new concepts that I was learning. So that was really great about this course that I appreciated and I think it made me remember a lot of concepts a lot more.

@1:20 - Courtney: What sort of program were you looking for when you chose this program specifically and were you placed at the content of the course once you got started?

@1:31 - APS: Yeah. I was just I wanted I was looking for a program that was there to enhance my skills and knowledge in terms of clinical research practices. I just wanted something to add to my resume something that I could add to my certifications to help just advance in the field to secure a better job. And I think a like here just doing it with CCRPS. It was just an amazing experience because, again, like I said, everything was not rushed, so I really took my time understanding each concept really well. There was a small community where I could always just like, talk into, there was a little chat block while I was learning, where we could just put in our application questions, and it was optional, but I just really thought it was a great learning tool. So overall, all of that just needed a very positive experience and I learned a lot.

@2:29 - Courtney: Yeah, that’s great. Is there any aspect of the course that you feel could have been enhanced to make the learning experience even more rewarding?

@2:38 - APS: Um, honestly, I really thought overall it was just a very rewarding experience for me because I’m so used to just doing my undergrad and masters, everything. Things have been just so like, go, go, go, and because this was so structured, but it didn’t like give you that, um, limitation on what you can do or how to learn. It just gave you a visual aspect, which was like the video training, as well as like the theoretical PDF that I could read from. It really helped with everyones learning styles. according to me, I think it’s just like a perfect overall package to contribute any type of learner.

@3:34 - Courtney: Are there any additional topics or elements that you wish were excluded that could have maybe further elevated your understanding of clinical research?

@3:44 - APS: You know, I really appreciated when they talked about ethical research in vulnerable populations. When I came to pregnant women and fetuses, or I came to prisoners or the mentally incapacitated, I really thought it went in really great detail. Having done my master’s in applied health, I have like a superficial level of information on that and I thought the certification courses, are many in the market that really offer this certification. However, this course just overall did a really good job going in depth, which I feel like wasn’t just, it wasn’t just covered just for the sake of covering content, but like the examples that were just presented and everything, all the information that was there was really great. So I, that was an aspect or a topic that I thought wouldn’t be covered. So I was surprised that it was covered.

@6:25 - Would you consider revisiting the course for a refresher? And then is there any specific information that you would want to see within a refresher course?

@6:35 - APS Yes, of course. I feel like a few years down the road, this is something that you should always just come back upon and just look at it, because all the information is just so dense that it’s hard for you to almost forget or just kind of go over certain details. If you’re in the field of clinical research, this is obviously something that I feel like every couple of years I would want to do a refresher course. And I feel like just going back to it, yes, there were a lot of major topics covered, but maybe if I’m doing a refresher course, I would just want to go back on informed consent, patient safety, vulnerable population, and data recording and handling, I feel like those would be like key refresher topics. I think key five concepts would be great to just refresh your memory and just highlight all the main concepts as well.

@8:55 - Courtney: Could you share what factors motivated you to choose this?

@9:00 - APS Yeah, I think what motivated me to choose this course typically was I was already in the lookout to enhance my skills and knowledge and advanced clinical research practices and I had been going through I think the other potentially competitive space that I was looking at was City, I think CITI or something because I am in Canada so I feel like most people who work at hospitals they kind of refer you to that however I had a really difficult time kind of just like navigating around the website and just figuring out what I really wanted they had plethora of options and it kind of got me really overwhelmed whereas when I just with one simple search and a click when I searched up what exactly I was looking for which was I see a GCP certification this was just there it told me exactly what it entailed, what it will teach me, and how I’l get my certification. And it was for me, it was just at my own pace and something that I’m just in that position where I’m looking for jobs. just wanted to take some time to learn and enhance my skills and add that to my resume. So this just was almost like a very easy option for me because it just catered exactly to me. So I really liked that and that was, it was just really easy for me to enroll.

@10:15 - Courtney: Can you share about your professional journey prior to embarking on this course and how you envisioned this course would contribute to your career growth?

@10:59 - APS: Yeah, so I I am just a very recent graduate from school, from Master’s. did my undergrad in medical science and then I did my master’s in applied health sciences. So I wanted to this year, I wanted to take some time after taking a year or two off. Wanted to branch off and kind of get into the clinical research space because your undergrad and masters, was heavily involved in research where I worked with individuals with multiple sclerosis and it was just something that was like very, it was great, I really enjoyed it, it was very practical. This very competitive and I could not just have my degrees as something that could highlight my accreditations in terms of job research. So I thought getting a certification like this would be very helpful because obviously if I’m getting into the clinical research space, I need to be able to hold up the ethical background, the ethical standards, and just have to comply to all these research tools. That was my motivation. And then after once I came across this course, I was like, this is perfect. I’m going to learn a little bit more and enhance my knowledge. And then maybe it’ll give me a little edge when I apply to job.

@12:39 - Courtney: Great. Okay. Then how long did it take you to complete the course and absorb the wealth of knowledge it offered? And then also do you feel that the duration of the course is adequate for the learning that it involves?

@12:51 - APS: It didn’t. Honestly, I’m just like one of those like go-getters type of people. If I started something, I need to be just, I just am in it. involved and absorbed. So I believe it didn’t take me more than a week to finish the course because that was just my goal. Just wanted to just indulge and just start learning about what is there and to make sure that I understood everything before I took the to apply to such positions. So it took me around a week, but however, after completing the course, doing the quiz, I think I still keep going back to certain topics and certain things that I learned to kind of just keep refreshing my thoughts and to just understand that it may be on a deeper level that I might have not understood the first time around as it is with many things we learned. So I thought I think we are able to access the course I believe for another year or even more, which is amazing because like you said, I feel like I can go back to it and refresh my memory until I don’t have that access anymore.

@14:41 - Courtney: Okay then after completing the course how did you update your resume to reflect the skills and knowledge that it gave you and then how has it enhanced your professional profile?

@14:49 - APS: Um honestly I think in my certifications category I have added the ICH GCP or the Advanced GCP to see in my thing. I feel like obviously it definitely puts me at the top of the pile along with others. I’m confident that this is definitely a great thing to have had on my resume,which I didn’t have before.

@15:51 - APS: Did [learning platform] facilitate a smooth and engaging learning process? Yes, of course. I feel like it was like I said, it was very structural. and such a comprehensive tool that everything about it was just very easy to navigate through from the videos to the PDFs that links were right under the video. So if someone is not a visual learner like myself, they could just go through all the slide along with the video which is a little bit more concise and they could just follow along if they needed more details. There were other tools such as PDFs that you could refer back to. So I feel like there was just no doubt in like the navigation process around the course. You could always go back to something. You could always come back to a slide or look for something specific.

@16:38 - Courtney: Can you share how the course boosted your confidence and prepared you for interviews or career advancements in clinical research?

@16:51 - APS: Yeah. The course has been very, very relevant to any role in clinical research at the moment. And I feel like it did give me a little boost of confidence for sure to be able to apply to all the just all the jobs that were actually specifically asking for, hey, to have knowledge of good clinical practice or ICH GCP, which before I was, I was like, yes, I learned about it. But I don’t know, you know what I mean, it was just never, I was never confident or definitely boosted my confidence in that aspect. And I’m able to now just say that, yes, I learned about this. I know about these. And like, I value what all these ethical tools that you need in clinical research and be able to apply it.

@17:48 - Courtney: For sure. What part of the course did you find most engaging and beneficial to your professional development?

@17:53 - APS: Um, I think the most engaging part, which I really appreciated overall. in the structural part were the videos because the videos were just really good in terms of when they started they started with the history of like why did we even need such ethical or ethical standards or such clinical practices in like how did we put them in order before when things started obviously these rules and regulations weren’t there so I feel like it did a great job in explaining why we need to learn because I feel like certain people have that like for me if I’m learning something I want to know why I need to learn it and what was the root of it so I feel like that the course did a really great job in that and sorry I didn’t get the second part of the question.

@19:35 - Courtney: What are some reasons that you would recommend this course to others based on your experience?

@19:40 - APS: Well, there’s many first I feel like one reason I would definitely say is that it was just very very organized and structured that you’re able to follow From point a to point b to c so that by the time you’re you have to write your exam you know exactly the path you’ve learned and like you know th chronological order I guess of like how the research practices came into application so I feel like that is one of the I feel like it was just super easy to navigate super convenient very user friendly so I felt like I think that is something that everyone wants nobody wants to get confused and overwhelmed with other concepts like I did with other websites I feel and other institutions so and then see I feel like obviously you’e getting such a great such a great certification to add to your profile and it’ll obviously boost your resume and boost your confidence and I feel like you’re obviously advancing your career in that part aspect of study obviously this is just one of the courses that you guys offer so there’s many others that I was also looking at just doing like a clinical research coordinator or an associate if I need if need be in the future so I feel like yeah I just definitely recommend this course to anyone and I feel like whoever is looking to advance in their career whenever this could just be a perfect time saving thing I think because it’s to the team you can take your time but you just know that it’s not going to drag on. I feel like it’s a great course.

@22:00 - Courtney: I appreciate your time and You took to share your experiences and it’s certainly gonna help us just refine the courses for future learners So I really appreciate you and our good luck

@22:26 - APS: Thank you so much Courtney Thank you for your time as well, and it was a great chat.

Connect with with Aastha our recent February 2024 graduate here.

If you haven’t heard the story of TAK Flight 363, pay attention — it might save you hundreds of thousands of dollars or more on your next clinical research study by protecting you against CRA fraud.

But how is an airline flight relevant to clinical research or CRA fraud, you ask?

As it turns out, in more ways than you might think.

You see, Flight 363 was a passenger airliner that found itself attempting to land at Kazan International Airport in Russia, on November 17, 2013.

Sadly, the jetliner crashed, and all passengers and crew on board lost their lives.

The investigation into the crash revealed that the captain of the flight had obtained his pilot's license using falsified documents. He had not completed the required training and had significantly overstated his flying experience.

The tragic story of Flight 363 underscores the grave consequences that can result when an organization fails to properly vet the qualifications and integrity of its employees.

While the pilot's fraudulent actions are reprehensible, the airline's hiring process allowed an unqualified pilot with critical skill gaps to slip through the cracks.

With devastating results.

As a clinical research employer or hiring manager, this cautionary tale serves as a reminder to closely examine your own hiring practices and ensure that you have the necessary safeguards in place to prevent unqualified people from joining your clinical research team.

This CCRPS guide helps you identify any vulnerabilities in your hiring process that bad actors could exploit, and gives you the tools and techniques to combat them. Let’s dive in.

Is CRA Fraud Really a Problem You Need to Worry About?

You might be surprised to hear this, but many senior-level professionals in the clinical research industry are somewhat indifferent to the issue of CRA fraud.

The sentiment seems to be: the system still works. If it ain’t broke, don’t fix it, right?

This isn’t an accurate assessment of the risks. The outcomes of bad hires in clinical research may not garner as much media attention as the crash of an airliner, but the stakes can be just as high.

A botched study might lead to an ineffective treatment wrongly progressing to the next stage of development, or an effective one getting delayed or canceled due to sloppy procedures. In both cases, the consequences can sometimes be literally life or death for the people whose lives the treatment affects.

Aside from the potential human costs, the direct monetary costs to your organization are also very real.

Recent data show that even small-scale RCTs can cost more than $200K on the lower range. And depending on who you ask, larger studies for medical device or drug development can cost anywhere from $49 million, or $54 million, to even $375 million per drug or device.

Incidentally, that much money can buy you about 18 airliners of the kind that were involved in the Flight 363 crash. In other words, the fallout of a ruined study can be monetarily even more damaging than writing off a state-of-the-art commercial jet.

The Real Costs of Fake Qualifications

The scenarios above aren’t purely hypothetical. In recent years, there have been many examples of Contract Research Organizations (CROs) and sponsor companies facing the consequences of inadequate CRA hiring and oversight.

In 2016, the FDA issued a warning letter to Semler Research, citing data integrity issues that stemmed from unqualified or inadequately trained clinical research staff, including CRAs. The resulting unreliable study results not only damaged the CRO’s reputation but also impacted the sponsors who had relied on their services.

Similarly, Cetero Research faced significant fallout from data integrity issues arising from poor CRA training and oversight, among other things. In this case, it led to the company’s bankruptcy and forced several sponsors to repeat studies at a cost of millions of dollars.

As these examples illustrate, the costs of hiring unqualified or fraudulent CRAs can be staggering, both in terms of direct financial losses and long-term reputational damage.

Cases of clinical research staffers lacking sufficient or authentic training and experience are also not isolated incidents. Authors of a 2021 study found that more than 12 percent of resumes for positions in health research were fraudulent.

Based on our interactions with dozens of the top employers in the industry, we believe that that number has grown. In 2024, we estimate that the incidence of applications with fraudulent qualifications can be as high as one in every five or six resumes in certain recruitment pools.

Fraud-proofing Your Clinical Hiring Process

As an employer, your responsibility includes ensuring that your hiring process is rigorous enough to identify and weed out candidates who lack the necessary qualifications, experience, or integrity to perform critical roles, whether those are CRAs, research coordinators, or data managers.

But as HR teams everywhere will attest, the prevalence and sophistication of fraud in the hiring process is constantly on the rise.

No sooner do recruiters spot and plug a racket than new ones turn up in a matter of days.

Effective screening means going beyond basic resume reviews and gimmicky portals that claim to solve the problem using simplistic tests and tools.

Here’s how.

1. Go Beyond the Obvious Clinical Role / CRA Red Flags

You already know the usual suspects:  discrepancies in documentation and employment history, vague answers to technical questions, and a lack of any verifiable digital footprint.

Push beyond these to uncover other telltale signs of an unqualified or under-qualified candidates, including:

Misunderstanding of Niche Skills

Candidates presenting a generic understanding of CRA or CRO functions, but lacking specific knowledge in the therapeutic area they claim expertise in. For example, claiming to be an oncology CRA but unable to explain common trial endpoints and standard-of-care treatments.

For instance, we came across a CRO manager who mentioned a CRA who kept referencing a “one five seven two form,” instead of the industry-standard “fifteen seventy-two” terminology. By itself, a single cue like this means nothing, but a lot of these subtle signs can add up — don’t ignore them.

Over-emphasis on Speed

Candidates may focus heavily on metrics of speed over quality. For example, boasting about high patient recruitment numbers without being able to discuss retention or data quality strategies. This may suggest a willingness to take shortcuts for the sake of appearances.

Cookie-Cutter Answers

Providing overly polished and rehearsed answers in interviews, particularly for scenario-based questions. This may indicate memorization rather than genuine problem-solving skills or an ability to adapt to unique trial complexities.

New AI tools can help you rapidly generate expert-level questions and answers, so that you don’t have to confine yourself to a limited bank of overused interview questions.

2. Use Multi-modal Interviews

Combine traditional in-person or video interviews with asynchronous video assessments, where candidates record their responses to a set of predetermined questions.

This allows you to evaluate a candidate's communication skills, poise, and subject matter expertise in a more controlled setting, while also making it harder for them to receive off-camera assistance.

Platforms like Glider.ai offer features such as facial recognition, eye-tracking to detect shifts in gaze, and audio analysis to flag suspicious noises like typing, whispering, and background voices.

Services like HireRight.com and Ferretly.com can bolster your background verification effort, with features such as AI-powered social media analytics to mitigate the risks of fraud and bad hires.

3. Maintain a List of Suspicious Employers and Institutions

There are actually unscrupulous businesses out there that offer fake employment credentials and even references for a fee. Maintaining a database of companies that consistently turned up on the resumes of disqualified candidates or bad hires will help you improve your process over time.

The same is also true of training institutions. There are dozens of sketchy institutions whose training is of questionable quality and sometimes even entirely nonexistent. (We’ve even come across accounts of self-professed training institutions whose curriculum consists of nothing but PDFs downloaded from the FDA website.) 

These businesses typically attract freshers with the promise of “guaranteed” jobs (a big red-flag for any training institution). Below are just a handful of examples.

4. Foster a Culture of Openness and Responsibility

While it may seem counterintuitive, creating a culture of fear can actually increase the risk of fraud going undetected.

When individuals feel that they will be severely punished, they go to greater lengths to conceal their deception, using more sophisticated methods and enlisting the help of others to cover their tracks.

Instead, consider fostering a culture of openness and responsibility, where CRAs and other staffers feel safe to admit mistakes, ask for help, and report concerns without fear of retribution.

There are five key elements to achieving this:

i. Establish Clear Reporting Channels

Provide multiple, confidential avenues for CRAs to report any concerns or suspicions of fraudulent activity, such as an anonymous hotline or a designated ombudsman. Make sure these channels are well-publicized and easily accessible.

ii. Encourage Open Communication

Create regular opportunities for CRAs to provide feedback and raise concerns, such as town hall meetings, surveys, or one-on-one check-ins with managers. Actively listen to their input and take appropriate action to address any issues they raise.

iii. Provide Support and Resources

Offer training, mentoring, and other resources to help CRAs succeed in their roles and overcome any challenges they may face. Make it clear that the organization is invested in their success and is willing to provide the support they need to do their jobs with integrity.

iv. Recognize and Reward Ethical Behavior

Publicly acknowledge and celebrate CRAs who demonstrate integrity, honesty, and commitment to quality. Use these individuals as role models and ambassadors for your organization's values.

Remember to address concerns promptly and fairly. When team members report issues or admit mistakes, investigate them promptly and thoroughly, and take appropriate action to address any shortcomings. Be transparent about the process and the outcomes to avoid any perception of retaliation or unfairness.

v. Foster a Sense of Shared Responsibility

Emphasize that maintaining the integrity and reputation of the organization is everyone's responsibility, not just management's. Encourage CRAs to see themselves as partners in the fight against fraud, and to take proactive steps to identify and prevent it.

5. Build Your Own “Talent Pipeline”

While hiring experienced CRAs is ideal, the reality is that the talent market is tight.

Investing in high-quality, targeted training for entry-level recruits can be a strategic solution to combat CRA shortages, accelerate a new hire's proficiency on the job, and improve your organizational outcomes. Here’s how:

Tailored Training

Partnering with established training providers like CCRPS, who specialize in CRA training, allows CROs to quickly onboard new hires with the core theoretical knowledge and practical skills needed.

We’ve worked with dozens of companies in the industry, and our clients consistently report significant performance improvements with new hires who complete our training program.

Address Specific Needs

Even with pre-hire experience, CRAs may have gaps in specific therapeutic areas or familiarity with your CRO's standard operating procedures (SOPs). Customized training can bridge these gaps, leading to faster deployment and better study outcomes.

Improve Cost-Effectiveness

It doesn’t take a mathematician to work out that the costs of training are insignificant compared to the cost of redoing studies or the cost of waiting endlessly to find the scarce "perfect" experienced candidate.

Trained entry-level CRAs reduce internal training burdens, improve project efficiency, and contribute to higher retention rates by fostering growth.

And of course, developing a reputation for investing in entry-level CRAs helps attract top talent in terms of candidates committed to career growth. This positions your organization for success even in a tight labor market.

The Disruptive Future of CRA Fraud Prevention

The current approach to CRA fraud (or fraud in any clinical role, for that matter) is largely reactive, patching vulnerabilities as they surface.

This status quo of reacting to ever-evolving fraud tactics is insufficient. To stay ahead of the curve, CROs and clinical research employers must become disrupters themselves.

I know the article title promised five actionable strategies, but in the typical CCRPS spirit of more is more, here are further ideas for you to consider — if your organization is ready for more advanced measures:

Leveraging Game Theory: Model the decision-making process of fraudsters to understand their vulnerabilities. Can strategic changes in hiring and verification make it less profitable or riskier for them to target CROs?

Data-Driven Prediction: Could tools built on large datasets identify early warning signs of high-risk candidates? Imagine a solution that analyzes transcripts, interviews, reference check patterns, and online footprints to go beyond just existing techniques.

Unconventional Techniques: What if your organization used ideas from outside the clinical research industry? For instance, using “red teaming” methods from cybersecurity can harden your process against fraud, and collaborating with academic researchers specializing in behavioral psychology could yield insights that discourage bad apples.

This isn't a call to embrace these disruptive ideas blindly, but rather a challenge to foster a culture of innovation and calculated risk-taking. CROs who lead the way in transforming the fight against fraud won't just protect themselves, they'll shape the future of a more secure and trustworthy clinical research industry.