Montenegro Clinical Research Career Guide
Clinical research is a field with great career potential all over the world. Clinical research associates, or CRAs, are one of the most sought-after positions in the field. CRAs monitor labs and research processes. It is a position that offers financial security and many traveling opportunities for work. In this article, we have put together a short work guide on becoming a CRA in Montenegro.
Salary:
The average salary for a Clinical Research Associate (CRA) in Montenegro in 2024, as per data from SalaryExplorer, is 3,090 EUR per month. However, this figure can vary depending on factors such as experience and location.
For those with less than 2 years of experience, the average monthly salary stands at 1,610 EUR. After gaining 2 years of experience, there is a notable increase of 33%, bringing the average salary to 2,150 EUR per month. With 5-10 years of experience, CRAs can expect a further increase of 48%, resulting in an average salary of 3,180 EUR per month.
Overall, salaries for CRAs in Montenegro can range from 1,420 EUR to 4,910 EUR per month, contingent upon individual circumstances.
Requirements to Work:
The minimum education requirement to work as a CRA in Montenegro is a bachelor’s degree. However, investing in a master’s degree will increase your qualifications and earning power. SalaryExplorer has shown that CRAs with a master’s degree have a 93% higher average salary than CRAs with just a bachelor’s degree.
Although clinical research is a global field, job requirements and salaries can differ from place to place. After reading this guide, we hope that you have a better understanding of what it is like to work in Montenegro. If you want to learn more about clinical research and becoming a CRA, please check out our CRA training program and our articles below to learn more about the international job scene.
Explore Courses for Clinical Research Careers in Montenegro
Courses Available:
CRO in Montenegro
Offices in Montenegro:
E-mail: info@clinres-farmacija.hr
Web: http://www.clinres-farmacija.hr
Clinres farmacija,Bul. Svetoga Petra Cetinjskog 114/I,81000 Podgorica,Crna Gora
Europe Clinical Research Career Guide
Europe Clinical Research Career Guide
Clinical research remains a field with significant career potential worldwide. Clinical research associates (CRAs) continue to be highly sought after, overseeing lab and research processes. This role offers financial security and the possibility of frequent work travel. This guide provides an updated overview of becoming a CRA in the EU.
Salary:
EU CRA salaries still vary considerably. While Payscale may cite older data for the Netherlands (€42,874), consult recent job postings and salary comparison websites for the most accurate figures. Glassdoor (https://www.glassdoor.com/index.htm) or Indeed (https://www.indeed.jobs/) can be helpful resources. Germany, for instance, might show a higher average closer to Salaryexpert's €59,969 estimate (though this could also fluctuate). Researching your specific country's CRA salary range is crucial.
Requirements to Work:
Successful CRAs come from diverse backgrounds, but the minimum education requirement in most EU postings remains a Bachelor's degree with a strong science focus. Many companies still seek candidates with 1-2 years of relevant experience. Be aware that some companies may prioritize experience within the country they operate in. Bilingualism remains important – fluency in English and the country's official language is generally expected.
Additional Considerations:
Clinical Trial Regulations: The EU has its own set of clinical trial regulations (GCP). Consider familiarizing yourself with these for a competitive edge. You can find information on the EU GCP guidelines on the European Commission website (https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-clinical-practice).
Continuing Education: Staying updated on the latest advancements in clinical research through conferences or online courses can enhance your skillset.
CROs vs. Pharma: Research opportunities exist with both Contract Research Organizations (CROs) and pharmaceutical companies. Explore which environment best suits your career goals.
Conclusion:
While clinical research is a global field, job requirements and salaries can differ across the EU. This guide aims to provide a starting point. Consider further research tailored to your specific country and desired career path within clinical research.
Explore Courses for Clinical Research Careers:
Remote Monitoring is The Future of Clinical Research
Remote Monitoring is The Future of Clinical Research
Remote clinical trials are not new topics in clinical research. Scientists have long suggested the use of virtual or decentralized clinical trials, but the recent pandemic has pushed these ideas into the spotlight. The FDA has encouraged the use of technology, non-contact drug deliveries, and telehealth for clinical trials.
Thus, experts believe that the implementation of decentralized clinical trials has been accelerated by 1-2 years. Although some may believe that remote clinical trials will only be a temporary fix for the current situation, many professionals believe that they will reshape the future of clinical research.
In a financially unstable time, remote clinical trials have drastically reduced the cost of conducting clinical trials. By reducing the number of patient visits, companies are using less staff and these staff are working fewer hours.
The financial benefits of utilizing remote trials will likely impact future trial designs and continue to attract the attention of businesses long after the pandemic.
In addition to being less expensive, going virtual has helped trials become more efficient on every level. AI programs have been used to successfully find eligible patients for trials. For those interested in learning about the utilization of AI and improving trial efficiency, consider the Advanced Clinical Research Project Manager Certification.
Virtual clinical trials are making participation more accessible, especially those who live in rural areas and have mobility issues. By simplifying trials participation and accessibility, researchers expect a decrease in dropout rates.
Since most data are collected directly from the patient’s electronic device, researchers have been using automated programs to analyze and store patient data immediately after collection. Those looking to deepen their understanding of data management in clinical trials might explore the Clinical Research Coordinator course.
Although there have been concerns about data accuracy and security, many believe that future technology will be the solution to these problems. These improvements in efficiency have resulted in shortened timelines, which are appealing to sponsors for requiring less funding.
Due to the positive outcomes of remote clinical trials, many investors are recognizing the current and future potential of virtual clinical trials. In July 2020, Medable, a virtual clinical trials company, started working with healthcare data firm Datavant to run decentralized trials.
Additionally, PPD and Covance have also teamed up with Medable to create a better virtual clinical trial experience. Medable’s CEO and cofounder, Michelle Longmire, M.D., plans to cut clinical trial timelines by 50% by incorporating more data sources in digital trials.
One month later, in August 2020, Science 37, another virtual clinical trials company, raised $40 million to create new virtual trials technology. The company plans to focus on patient accessibility as well as simplifying the implementation of decentralized trials for CROs and pharmaceutical companies.
There is no doubt that covid 19 has altered the way clinical research is conducted and quickly creating a new field of opportunities. The incentives of using clinical research are attracting large funding from investors and steadily creating a lucrative field in clinical research.
Since decentralized and virtual clinical trials are here to stay, enterprising professionals should start to master the art of working remotely in clinical research. If you are interested in pursuing or furthering your career in clinical research, please check out our specialized training programs such as Pharmacovigilance Certification, CRA Certification, ICH-GCP Training, Clinical Trials Assistant Training, Advanced Principal Investigator Physician Certification, and Medical Monitor Certification below to learn more about the clinical research job scene.
Clinical Research Careers in India
Clinical Research Courses in India - US Certification
Your Fast Track to a Rewarding Career as a Clinical Research Associate (CRA) in India
The world of clinical research is booming, and India is a hotspot for exciting opportunities. If you're looking for a career that combines science, travel, and the chance to make a real difference in people's lives, then becoming a Clinical Research Associate (CRA) might be the perfect fit!
Why be a CRA in India?
Financial Security: The average salary for a CRA in India is ₹342,978, with experienced CRAs earning significantly more (Salary reference: Glassdoor https://www.glassdoor.co.in/Salaries/clinical-research-associate-salary-SRCH_KO0,27.htm). Entry-level CRAs can expect to start around ₹298,118, and experienced CRAs can reach an average of ₹696,343.
Travel Perks: CRAs often travel to different research sites, offering a chance to experience new places and cultures.
Global Impact: Your work contributes to the development of new medications and treatments, impacting lives worldwide.
Becoming a CRA in India: A Step-by-Step Guide
Education: A Bachelor of Science (B.Sc.) in a science field like biology, chemistry, or pharmacy is the minimum requirement. However, a Master's degree (M.Sc., M.Pharma, or Ph.D.) will make you a more competitive candidate.
Experience: While not always mandatory, 1-2 years of experience in research or healthcare will give you a head start. Consider internships or volunteering opportunities to gain relevant skills.
Certification: Good Clinical Practice (GCP) certification demonstrates your understanding of ethical research practices and is highly valued by employers.
Additional Tips:
Network: Attend industry events and connect with professionals on LinkedIn to learn more about the field and find potential opportunities.
Highlight Your Skills: Develop strong communication, organizational, and problem-solving skills. Attention to detail is crucial for CRAs.
Ready to Take the Next Step?
Explore our website for resources on becoming a CRA, including articles on the international job market. We can also help you find India-specific CRA training programs at competitive prices.
Clinical Research Coordinator: Interested in managing and overseeing clinical trials? Consider becoming a Clinical Research Coordinator: https://app.ccrps.org/courses/Clinical-Research-Coordinator.
Pharmacovigilance Certification: Specialize in monitoring the safety of pharmaceuticals by exploring the Pharmacovigilance Certification: https://app.ccrps.org/courses/pharmacovigilance-certification.
Clinical Research Associate (CRA): Learn to monitor clinical trials effectively and ensure compliance with regulations by becoming a Clinical Research Associate (CRA): https://app.ccrps.org/courses/cra.
ICH-GCP (International Conference on Harmonisation - Good Clinical Practice): Gain an understanding of the ethical and quality standards in clinical research through the ICH-GCP course: https://app.ccrps.org/courses/ich-gcp.
Getting Started in Clinical Trials
Clinical Trials Assistant Training: Starting your career in clinical trials? Consider the Clinical Trials Assistant Training: https://app.ccrps.org/courses/Clinical-Trials-Assistant-Training to get foundational skills.
Advanced Clinical Research Careers
Advanced Clinical Research Project Manager Certification: Aiming to lead clinical research projects? The Advanced Clinical Research Project Manager Certification: https://app.ccrps.org/courses/Advanced-Clinical-Research-Project-Manager-Certification might be the next step.
Advanced Principal Investigator Physician Certification: Aspire to lead clinical trials? Consider obtaining the Advanced Principal Investigator Physician Certification: https://app.ccrps.org/courses/Advanced-Principal-Investigator-Physician-Certification.
Medical Monitor Certification: Specialize in monitoring the medical aspects of clinical trials with the Medical Monitor Certification: https://app.ccrps.org/courses/medial-monitor-certification.
Email us for more information on finding the perfect program to launch your exciting career in Clinical Research!
5 Tips and Tricks to Working from Home in Clinical Research During a Pandemic…or remotely
The COVID-19 crisis has created a new normal in the workplace. Many companies have required their employees to work remotely as much as possible, and the clinical research field is no different. In this unprecedented time, the FDA has encouraged the use of technology, telehealth, and remote drug deliveries for conducting clinical trials. For many clinical research professionals, the shift to remote work can be challenging and difficult to navigate. However, experts believe that virtual clinical trials are going to be a huge part of the field’s future. To effectively manage these trials, consider the Advanced Clinical Research Project Manager Certification. This article has compiled some of the best tips and tricks to help you plan a productive and fulfilling workday at home.
Check Out Company Guidelines
Working in a pandemic is a special circumstance that deserves special considerations from employers. What a lot of people forget is that most companies have created HR guidelines for employees working during a time of crisis. Reviewing these guidelines can help you understand your company’s remote work policies, as well as procedures and expectations. For those looking to further understand and comply with regulatory standards, consider exploring the ICH-GCP course to deepen your knowledge on international guidelines. Additionally, the role of Pharmacovigilance Certification is crucial in ensuring drug safety, which is paramount during such trials.
Enhancing Team Coordination
Effective communication is key in remote work settings, especially when coordinating clinical trials. Clinical Trials Assistants play a vital role in this, and gaining specialized skills through the Clinical Trials Assistant Training can enhance your ability to manage projects efficiently. For Clinical Research Associates (CRAs), who ensure the smooth execution of these trials, the CRA certification can provide the necessary training to adapt to the evolving landscape.
Special Roles in Clinical Research
For advanced positions such as Medical Monitors and Principal Investigators, specific certifications like the Medical Monitor Certification and the Advanced Principal Investigator Physician Certification are essential. These certifications prepare you for high-level oversight and critical decision-making roles necessary for the success of remote clinical trials.
Set physical and social boundaries
One of the chief complaints of working from home is being unable to focus. It is easy to get distracted when you are a few steps from the TV, or you are sharing the space with other people. To have a distraction-free workday, it is important to create a designated workspace that you feel comfortable working in. This way, as soon as you enter the room, your brain is ready to concentrate on the right thing.
In addition, although it is important to socialize, set boundaries with those around you to make sure that you leave the socializing to after work is over.
Get into a Routine
Even though you are working from home, it can be very helpful to a structured schedule. When creating a work routine, it is not only important to determine when you should start working, it is also important to determine when you should stop. This helps prevent burnout and allows you to focus on other important things in your life.
Get the Right Tech
When you’re in clinical research, having reliable technology is vital to many positions. For example, it is important that your computer can run the programs and softwares you need for your job. Otherwise, you might have to consider getting an upgrade before going remote. Additionally, it is important that you understand how to use virtual communication programs like Zoom, so you can connect regularly and effectively with your boss and colleagues.
Over Communicate
Out of all of the tips discussed in the article, this one is the one that most experts agree on. As you begin working remotely, you will notice very quickly that it is harder and more important than ever to connect with your colleagues and managers. It is not only helpful to update your colleagues and bosses more frequently, it is also important to keep up social habits you had before the pandemic. If you always talked to a particular colleague before the weekly meeting, try giving them a call before the same virtual meeting. This way, you’ll be able to maintain your old routine and keep up with your office even when you’re working from home.
Since the pandemic has drastically changed the way we work, here are some new ways to elevate your workday at home. As discussed in our other article, clinical research is developing a new perspective that generates new opportunities and to change the field. Virtual clinical trials (VCTs) are going to stay in the field, and the technical and self knowledge you gain working during this time will serve you well in future clinical research projects. If you want to learn more about the clinical research profession, please check out our specialized training programs and articles below to learn more about the clinical research job scene.
Learn more Work From Home Tips by Katie Holmes
Global Pharmacovigilance Regulations
Medicine is one of the most universal forms of healthcare. However, according to the American Society of Pharmacovigilance, adverse drug events alone are responsible for $13 billion in annual American healthcare costs. The U.S Department of Health and Human Services defines adverse drug events as undesirable consequences of taking certain medications, such as “medical errors, adverse drug reactions, allergic reactions, and overdoses”. It is internationally important that a medication is professionally assessed and monitored before it is deemed safe for consumers. This is where pharmacovigilance comes into play.
Pharmacovigilance (PV), or drug safety, is the study of a drug’s adverse effects. PV helps determine if a drug is safe for mass consumption before it is put on the market. In addition, PV ensures that if drugs with serious adverse drug reactions are pulled from the market. The field is an integral part in clinical research. In this article, we will explore the various agencies and regulatory bodies that supervise PV as well as clinical research. For those interested in becoming a pharmacovigilance expert, Pharmacovigilance Certification is available to guide you through the essentials of drug safety.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH): Created in 1990, the ICH connects global regulatory bodies and pharmaceutical companies to share technical innovations and discuss guidelines. The ICH GCP, or Good Clinical Practice, is one of the global governing clinical research guidelines for the EU, America, and Japan. Understanding and staying up to date with the ICH GCP is one of the most important qualifications someone could have before entering the clinical research industry. If you have any interest in clinical research and PV, CCRPS offers a free ICH GCP course that thoroughly explains and clarifies the complex document.
The European Medicines Agency (EMA): In the European Union (EU), the EMA coordinates PV and drug safety throughout all clinical trial phases. They ensure that a drug’s effects are monitored even after they are on the market. In addition to ICH GCP, the EU uses Good Pharmacovigilance Practice (GPvP) to determine monitoring standards of drug sales.
The Food and Drug Administration (FDA): In the United States (U.S.), the FDA supervises the approval of pharmaceutical products. Specifically, the Center for Drug Evaluation and Research or CDER is responsible for handling PV. Within CDER, the Office of Surveillance and Epidemiology assembles medical officers and safety evaluators to oversee PV in their field of experience. Most officers and evaluators are medical doctors or pharmacists.
Marketed Health Products Directorate (MHPD): The Canadian Directorate assesses and regulates health product risks. They are composed of 6 different bureaus and offices, each with their own area of speciality. Together, the Directorate monitors adverse drug effects and makes regulatory decisions.
Pharmaceuticals and Medical Devices Agency (PMDA): Established in 2004, the Japanese regulatory authority PMDA supervises the safety of drugs from the lab to the market. Not only do they consult clinical trial professionals on clinical compliance, they also provide post-market safety measures and relief services for adverse health effects.
Since drug safety is important for patient health and safety around the world, there are career opportunities for PV virtually anywhere. If you want to learn more about pharmacovigilance, please visit our website at CCRPS.Org. Our online Pharmacovigilance Certification guides new professionals to improve their qualifications and gain valuable insight. The course is curated by real clinical research professionals and flexible enough to fit any schedule. Moreover, for those looking to expand their career into clinical research coordination or clinical trials assistance, CCRPS offers comprehensive courses such as the Clinical Research Coordinator, Clinical Trials Assistant Training, CRA certification, Advanced Clinical Research Project Manager Certification, Advanced Principal Investigator Physician Certification, and Medical Monitor Certification.
5 Step Guide to Becoming a Successful PV Professional
Pharmacovigilance (PV), also known as drug safety, is the study of a drug’s effects. It is a specialized department within clinical research and it has a lot of potential. PV professionals record and analyze a medicine’s adverse effects before and after its clinical development. Much like clinical research, PV is a largely under-explored field with great career prospects. According to reports, the pharmacovigilance market is expected to reach $12.98 Billion worldwide by 2027. The field has opportunities for all kinds of talents, including IT and statisticians. In this article, we will break down the PV field and outline educational requirements and career tips in 5 steps.
Enroll Instantly in our Pharmacovigilance Certification with 17.5 CME Credits
Step One: Undergraduate Degrees
Most positions in PV require some level of higher education. The pharmaceutical industry is highly regulated, and employers need to be sure that you have the necessary interest and knowledge before they make a hire.
Depending on what kind of career you want in your future, an associate’s degree or bachelor’s degree can help you get there. If you are interested in clinical positions, a bachelor’s in the life sciences or health-related studies will be highly desirable. If you are interested in non-clinical positions, such as those in IT or statistics, a computer science or mathematics degree will help get you there.
During this time, look for any direct opportunities to work in clinical research. University hospitals are a great place for research assistant or patient recruiter opportunities. The PV field is hard to break into, so building relevant experiences and making connections will help you tremendously in the future. Consider enhancing your resume with a Clinical Trials Assistant Training course.
Step Two: Graduate Degrees
Graduate programs may be of interest to those who want better career opportunities or specific positions, such as a PV physician. Health professionals with degrees such as MDs, DOs, RPhs, PharmDs, RNs, LPNs, DDS/DMDs, and DVMs can easily transfer their degrees and work experience into PV positions.
On the other hand, many pursue a master’s or a PhD because they increase one’s earning potential and open up more career opportunities. If you choose to get your degree, make sure to take advantage of your school’s resources and industry connections while you still have access to them. Advanced roles may benefit from specific certifications like the Advanced Clinical Research Project Manager Certification or the Advanced Principal Investigator Physician Certification.
Step Three: Apply for Jobs
Here comes what many consider the hardest part of a PV career: breaking into the field. PV is a competitive field, and here’s how you stay ahead:
Highlight any direct clinical research experience and get a reference from your supervisor. This will be one of the best ways to grab an employer’s interest.
If you’ve taken a graduate PV program, take advantage of your school’s resources to help with placement and networking.
Join a professional association. Network and find out how practicing professionals landed their first job. Check the association job board for positions that may not be on other job boards.
Stay up to date and informed on field practices and trends. A way to demonstrate your enthusiasm and dedication is to take advantage of online courses. For example, CCRPS offers an affordable PV certification program as well as a free ICH GCP program. Both can help add to your resume.
Before you apply, polish your resume and prepare for questions. We have an in-depth article on how to ace your interview.
Plan your career ahead. We’ve done an article on how where you work can accelerate your career trajectory and help you obtain promoted faster.
Step Four: Work and Learn
PV is an ever-growing and innovative field. When you land your first job, be prepared to transition into the workforce and learn what you were not taught in the classroom.
As you work, take in the environment around you and contemplate your long-term goals. Some factors you should consider are:
What is the work culture like?
Do you have a mentor who can guide you through this career?
Does your work environment support your professional growth?
These questions can be important when you begin to apply for senior roles, especially if you are interested in line management roles. If you find that the company goals don't align with your own, it may be worth looking for a new position somewhere else.
Most importantly, as you settle into your new job, make sure that you continue to network and re-educate yourself on the field. The effort you invest in yourself will help you stand out to the right people. Consider taking a Medical Monitor Certification to further enhance your qualifications.
Step five: Applying for Senior Positions
When PV professionals have around 5-8 years of experience, most will apply for senior positions with better pay and benefits. Although senior positions tend to be very competitive, you will be equipped with years of experience and planning. When you are applying for senior positions, here are some aspects to consider:
Your work experiences and how they fit into the position you want. Consider what sets you apart from other applicants.
Your references should not only be able tell the employer your strengths, but also your weaknesses. While this might sound counterintuitive, hiring managers know that a reference that can’t speak about your weaknesses probably doesn't know you well enough to speak about your strengths. To them, an honest reference is the sign of a strong working relationship. This will help them infer the strength in your communications skills and work ethnic.
Your skills and qualifications should not only match the job description, they should demonstrate that you are going to be a valuable member of their team.
While navigating the PV field can be complicated, the process can be immensely rewarding. If you want to learn more about the PV field, visit CCRPS for more information on our courses and check out some of our other PV articles below.
How to Land a Career in PV
According to WHO, pharmacovigilance (PV) is the science of recognizing, analyzing, and preventing a drug’s adverse effects. It is an integral part of clinical research and drug safety. In this article, we will discuss PV’s career requirements and various specializations.
Education Requirements:
To join the PV field, you will need a bachelor's or graduate degree in medicine, pharmacy, nursing, or health sciences (ex: MD, DO, RPh, PharmD, RN, LPN, DDS/DMD, DVM) . A master’s or PhD will allow candidates to specialize and enjoy more employment opportunities. Some common PV specializations are:
data management
medical safety writing
quality management
compliance management
In addition to a formal education, you will also need direct experience in collecting, organizing, processing, and analyzing PV information. The field can be very data intensive, so having a background in data management or data mining can be a huge draw for employers.
How to land a position:
If you are looking for PV positions, you’ll notice that the most common employers are pharmaceutical companies, CROs, IT firms, KPOs, PV centers, and hospitals. Some great entry level positions are:
Pharmacovigilance Specialist (average salary: $68,995 )
Record and report a drug’s adverse events after it has been on the market
Pharmacovigilance Associate (average salary: $90,557)
Ensure that clinical trials developments are following regulatory compliance.
Pharmacovigilance Scientist (average salary: $123,499)
Analyze data and compile them into reports.
Often responsible for management and leadership.
Explore Pharmacovigilance Careers: Unlock Opportunities in Drug Safety
List of Courses:
These courses are designed to enhance your qualifications and prepare you for a successful career in the dynamic field of pharmacovigilance. Whether you're starting out or looking to specialize further, explore these educational opportunities to advance your career in drug safety.
To employers, your qualification will be the number one factor that determines their hiring decision. PV is a highly technical field, and not having the skills or education you need can be disastrous for your job search. If you want to show your qualification and enthusiasm for the field, a great option would be getting PV certified. CCRPS’ online pharmacovigilance course helps new professionals improve their qualifications and gain valuable insight. The course is curated by real clinical research professionals and completely flexible to your schedule. If you want to learn more about pharmacovigilance, please visit our website at CCRPS.Org.
Becoming a CRA in Canada Work Guides
Clinical research is a field with a lot of career potential all over the world. Clinical research associates, or CRAs, are one of the most sought after positions in the field. CRAs monitor lab and research processes. It is a position that offers financial security and many traveling opportunities for work. In this article, we have put together a short work guide on becoming a CRA in Canada.
Salary:
According to the Payscale, the average salary of a CRA in Canada is C$62,082. Entry level CRAs can expect to make an average of C$54,185. Late career CRAs make an average of C$107,500.
Requirements to Work:
Successful CRAs come from all kinds of backgrounds, but the minimal education requirement for a CRA in Canada is a B.A. or a B.S. with a strong focus in science. Many companies look for candidates with 1-2 years of work or monitoring experience. Since Canada’s 2 official languages are French and English, it will be important for candidates to be fluent in both languages
The Clinical Research Association of Canada (CRAC) offers a certification program for clinical research professionals to be recognized as a Clinical Research Professional of Canada (CRPC). The exam requires that you have either 2 years of clinical research experience within the last 5 years, 3,500 hrs of part time experience with at least 1 year of Canadian experience within the last 5 years, or a post-graduate certificate in clinical research and at least 1 years’ experience over the past 2 years in clinical research, where you must have at least 1 year of Canadian experience.
The certification helps already experienced professionals stand out in their fields and access better opportunities. At CCRPS, we offer a training program especially designed to help you ace the Canadian certification exam.
Launch Your Clinical Research Career in Canada: A Guide to Becoming a CRA
List of Courses:
Although clinical research is a global field, job requirements and salaries can differ from place to place. After reading this guide, we hope that you have a better understanding of what it is like to work in Canada. If you want to learn more about clinical research and becoming a CRA, please check out our website or some of our articles below to learn more about the international job scene.
How to Progress Your PV Career By Joining The Right Company
Pharmacovigilance (PV), or drug safety, is the study of a drug’s effects. Most importantly, PV monitors a drug’s adverse effects and protects consumers. PV professionals often find intellectually and financially fulfilling careers in the booming clinical research and pharmaceutical industry. Many start in the field in case management positions, but find it hard to access higher positions such as line management or technical specialists. Senior PV positions can be very competitive and difficult to acquire. However, doing research and planning ahead while you are applying for your first job can help you overcome these obstacles. Here are some tips on how to progress your career in PV.
Join the right company
When companies are hiring for senior positions, candidates must have the right qualifications and experience. However, critical experiences for higher positions can be hard to come by, especially in larger companies where case processing teams rarely work with senior level staff. When PV professionals feel that there aren't enough opportunities for growth in their work environment, one of the most effective strategies is to find and join a different kind of company. While this might seem drastic, making the change early can have lasting benefits on your career.
Here are ways your workplace shape your career:
Joining a smaller company and team will allow you to juggle more roles and gain the experience you need to apply for senior positions.
Joining a company where case processing occurs at the headquarter will allow you to work and network with more senior staff, which can prove extremely advantageous in the long run.
Joining a generics company could be the right move for you, especially if you are interested in senior technical roles. Since a generics company works with compounds that have expired patents and have been on the market for a considerable time, developing generic drugs carries less risk. Therefore, you are more likely to be promoted into signal detection work with less experience.
Joining regulatory or drug safety consultancies like CROs could also be smart for those interested in technical roles. They often offer job training for case processors to transition into signal detection roles. Additionally, since these companies specialize in outsourcing, working there would allow you to gain diverse product experiences and help your resume stand out.
Joining a health authority like the FDA or the EMA would allow you to read and analyze drug evaluations submitted by pharmaceutical companies. Your understanding on how to get approved by the regulatory bodies is a highly desirable skill set for pharmaceutical companies.
Advance Your Career in Pharmacovigilance: Navigating Opportunities in Drug Safety
List of Courses:
While applying for senior PV positions can be competitive and difficult, there are many ways for starting professionals to build their credentials while having an unique and fulfilling career. If you want to learn more about pharmacovigilance, please visit our website at CCRPS.Org. We offer an online pharmacovigilance course to help new professionals improve their qualifications and gain expert insight in the field. The course is curated by real clinical research professionals and perfect for a busy schedule.
Pharmacovigilance Positions and Careers in Clinical Research
What is Pharmacovigilance?
Drugs are an integral part of healthcare. New medications are constantly developed and tested by pharmaceutical companies to be put on the market. However, according to the American Society of Pharmacovigilance, adverse drug events account for: 1 million emergency department visits, 2.2 million hospital admissions, 3.5 million physician office visits, and $136 billion in U.S. health care annually. Thus, it is paramount that drugs are as safe they can be.
Pharmacovigilance (PV), or drug safety, is the study of a drug’s adverse reactions. PV professionals work in varying specialities to ensure that a drug is safe and tested before it is consumed by the masses. In this article, we will look at the different ways PV professionals contribute to drug safety in clinical research settings.
Why is PV Important?
A drug needs to be approved by the appropriate regulatory body before going on the market. In the U.S., the FDA determines if a drug is ready for the market. Before a drug can apply for FDA approval, it must undergo three phases of clinical trials. Every proceeding phase will involve more subjects and be more risky. Thus, it is important for the clinical research team and pharmaceutical company to be sure that a drug is safe before proceeding with the next phase.
What Roles are in PV?
In clinical research, PV operations work with the clinical research team to collect information on a drug’s SAE and ADR. SAE is a serious adverse event. They can be lethal or have major repercussions such as causing disabilities in the patient or inducing birth defects. On the other hand, ADR is an adverse drug reaction. ADRs include a drug’s milder side effects, like headaches, nausea, or fatigue. The safety data collected by the operations division is key to determining a drug’s use and safety.
In addition to data collection, the operations team is responsible for creating standard operating procedures (SOPs), as well as individual case study reports, literature screening, and regulatory expedited reporting on Suspected unexpected serious adverse reactions (SUSARs), or unknown as unexpected serious adverse reactions, after the drug is on the market.
The safety data collected by the operations division is maintained by the PV systems division. They ensure that an immense amount of data is organized and accessible to research collaborators. The systems team is always working to improve and maintain safety data, since field regulations and industry expectations are always changing.
After being organized by the systems division, the safety data is then handed to the PV surveillance team. PV surveillance analyzes the safety data and then compiles their insights into development safety update reports (DSURs). This report determines whether or not the drug is safe enough to move on to the next phase of clinical trials. At the end of the third phase, if the drug is safe enough, the PV will submit the drug for FDA approval.
How Do I Start?
The PV department needs and recruits diverse talents to ensure that a drug is safe. If you can see yourself in one of these positions, then you should absolutely consider a career in PV. CCRPS recently launched our pharmacovigilance course to help aspiring professionals learn about the field and stand out in front of employers. If you want to learn more about pharmacovigilance, please visit our website at CCRPS.Org.
For those who are considering further specialization within clinical research, opportunities such as becoming a Clinical Research Coordinator, CRA, or a Clinical Trials Assistant are also available. These roles are critical in the management and execution of clinical trials and offer a pathway to advanced positions like Advanced Clinical Research Project Manager Certification or an Advanced Principal Investigator Physician Certification.
For medical professionals looking to expand their expertise in overseeing clinical trial safety and compliance, our ICH-GCP course and Medical Monitor Certification provide comprehensive training in Good Clinical Practice and the responsibilities of a medical monitor in clinical research.
Top 7 Words Every Pharmacovigilance Professional Should Know
7 Key Terms You Need to Know
In the dynamic world of clinical research, ensuring medication safety throughout a drug's lifecycle is paramount. Pharmacovigilance (PV) stands as the guardian of this mission. But navigating this field requires fluency in its specific language. Here's a breakdown of 7 crucial terms every PV professional should understand in 2024, along with valuable resources to empower your journey:
1. Adverse Drug Reaction (ADR): Any unintended effect of a drug, regardless of severity or dosage. All ADRs are documented and evaluated for regulatory purposes.
Reference: Council for International Organizations of Medical Sciences (CIOMS) I Working Group III: A glossary of terms used in pharmacovigilance. Br J Clin Pharmacol. 1999;47(2):835-7. PubMed: https://pubmed.ncbi.nlm.nih.gov/10434043/
2. Side Effect: An unintended but expected consequence of a drug at the recommended dosage. Side effects differ from ADRs as they are anticipated outcomes of the medication.
Reference: Good Clinical Practice: E6(R2). International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. November 2016. Available online at ICH website: https://www.ich.org/
3. Adverse Drug Event (ADE): Defined by the International Council for Harmonisation (ICH) as any unfavorable medical experience during a patient's medication use. Unlike ADRs, ADEs don't necessarily imply a causal relationship with the drug.
Reference: International Council for Harmonisation (ICH) Guidance for Industry E6(R2) Good Clinical Practice: ICH Topic E6. Available online at ICH website: https://www.ich.org/
4. Serious Adverse Event (SAE): A severe medical reaction to a drug at any dose, including life-threatening situations, hospitalization, disability, or birth defects. PV professionals assess reported events to determine if they meet SAE criteria.
Reference: ICH Topic E6(R2) Section 4.8 Definitions and Abbreviations. Available online at ICH website: https://www.ich.org/
5. Unexpected Adverse Drug Reaction (USADR): An ADR not previously documented in the drug's local labeling. If a USADR is also serious or life-threatening, it becomes a Suspected Unexpected Serious Adverse Reaction (SUSAR). These occurrences require prompt reporting to regulatory bodies by PV teams.
Reference: Regulation (EU) No 1381/2007 of the European Parliament and of the Council of 20 November 2007 on the transparency of medicinal products for human use and amending Directive 2001/83/EC, Council Regulation (EC) No 2587/95 and Directive 2004/27/EC. Europa.eu website: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32007R1381
6. Signal Detection: A cornerstone of pharmacovigilance. PV professionals leverage data analysis tools to identify trends and deviations from expected patterns in drug safety data. Signals may indicate a new, potential drug effect, either beneficial or adverse.
Reference: World Health Organization (WHO) Guidelines for Standardized MedDRA Coding and Use in Pharmacovigilance. WHO website: Although not directly related to signal detection, this is a relevant WHO resource: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
7. Causality Assessment: The process of determining the likelihood that a drug caused a reported ADE. This assessment helps PV professionals establish the level of association between the medication and the adverse event. Causality assessments can range from:
Certain: There is clear and convincing evidence that the drug caused the ADE.
Probable/likely: It is more likely than not that the drug caused the ADE.
Possible: There is a chance that the drug caused the ADE, but other factors could also be responsible.
Unlikely: It is improbable that the drug caused the ADE.
Conditional/unclassified
In addition, if you want to be more qualified in the field of clinical research, you may want to consider getting certified in several key areas. A great starting point is the CCRPS’ online pharmacovigilance course, which helps new professionals improve their qualifications and gain expert insight in the field. This course is curated by real clinical research professionals and is flexible to your schedule.
If you’re aiming to further enhance your career, CCRPS offers a variety of specialized courses tailored to different roles within clinical research. Those interested in coordinating clinical trials might consider the Clinical Research Coordinator course. For those looking to oversee clinical trial conduct, the CRA (Clinical Research Associate) course is ideal.
Aspiring clinical trials assistants who support clinical research sites can benefit from the Clinical Trials Assistant Training. If you are pursuing leadership roles in clinical research projects, the Advanced Clinical Research Project Manager Certification might be the right choice.
For physicians who wish to lead clinical studies, the Advanced Principal Investigator Physician Certification can provide the necessary expertise. Furthermore, individuals interested in ensuring the safety and efficacy of clinical trials may find the Medical Monitor Certification extremely useful.
Finally, to stay compliant with international standards in clinical research, consider our ICH-GCP (International Conference on Harmonisation - Good Clinical Practice) course, which is crucial for anyone involved in global clinical research.
To explore these courses and learn more about how they can enhance your career in clinical research, please visit our website at CCRPS.Org.
What is Pharmacovigilance (PV)
According to the American Society of Pharmacovigilance, every year 1 million emergency department visits, 2.2 million hospital admissions, and 3.5 million physician office visits are caused by adverse drug effects. To prevent these tragedies, there is a special department in clinical research called pharmacovigilance. Pharmacovigilance, or drug safety, is the study of a drug’s adverse effects. PV professionals determine a drug’s safety and effectiveness before it is released into the market.
PV is a vast and complex discipline that requires diverse skill sets. Some roles may require administrative expertise, while others require firm understanding of statistics. Regardless, the PV department’s teams and divisions all collaborate towards one goal: to improve drug safety. Some common PV positions include:
Pharmacovigilance Specialist (average salary: $68,995 )
They record and report a drug’s adverse events after it has been on the market
Pharmacovigilance Associate (average salary: $90,557)
They ensure that clinical trials developments are following regulatory compliance.
Pharmacovigilance Scientist (average salary: $123,499)
They analyze data and compile them into reports. They are also often responsible for management and leadership.
Although there are many different positions within PV, many share common responsibilities such as:
Medical evaluation,
Assessment of expectedness and drug-ADR associations,
Casualty assessment,
Case narratives and processing,
Use of medical dictionaries,
Data mining and signal detection,
Medication error related activities
Specialized services (writing, compliance, global PV, ect)
To work in PV, you need at least a bachelor’s degree in the health sciences as well as relevant experience. Many professionals from nursing, pharmacy, and medicine find successful careers in PV. However, it is a competitive field. In PV, technical qualifications and a well rounded understanding of the human body are everything. At CCRPS, we offer a pharmacovigilance certification course that will help you better understand the industry and improve your qualifications.
Explore Career Advancements in Pharmacovigilance
Pharmacovigilance Certification
This certification will equip you with the necessary skills to effectively manage and report adverse drug reactions and ensure compliance with regulatory laws.
Clinical Research Coordinator Certification
Learn the fundamentals of clinical research coordination, enhancing your ability to manage clinical trials and patient care effectively.CRA Certification
As a Clinical Research Associate, gain expertise in monitoring clinical trials and ensuring adherence to established guidelines and regulations.ICH-GCP Certification
This certification provides thorough training in the International Conference on Harmonisation - Good Clinical Practice guidelines, crucial for anyone involved in clinical trials.Clinical Trials Assistant Training
Prepare for a role as a Clinical Trials Assistant, where you will support the administration and operational aspects of clinical trials.Advanced Clinical Research Project Manager Certification
Develop advanced skills in managing complex research projects, overseeing trial progress, and ensuring projects meet their objectives.Advanced Principal Investigator Physician Certification
This course is designed for physicians who wish to lead clinical trials, focusing on the intricacies of trial management and regulatory compliance.Medical Monitor Certification
Gain specialized skills in monitoring and overseeing the medical aspects of clinical trials, ensuring patient safety and the integrity of clinical data.
What is the Role of Pharmacovigilance in Clinical Research
What is Pharmacovigilance?
Drugs are an integral part of healthcare. New medications are constantly developed and tested by pharmaceutical companies to be put on the market. However, according to the American Society of Pharmacovigilance, adverse drug events annually account for: 1 million emergency department visits, 2.2 million hospital admissions, 3.5 million physician office visits, and $136 billion in U.S. health care costs. Thus, it is paramount that these drugs are as safe they can be.
Pharmacovigilance (PV), or drug safety, is the study of a drug’s adverse reactions. PV professionals work in varying specialties to ensure that a drug is safe and tested before it can be consumed by the masses.
Why is PV Important?
A drug needs to be approved by the appropriate regulatory body before going on the market. In the U.S., the FDA determines what drugs are ready for the market. Before a drug can apply for FDA approval, it must undergo three phases of clinical trials. Every proceeding phase involves more people and more risk. Thus, it is important for the clinical research team and pharmaceutical company to be sure that a drug is safe before proceeding with the next phase.
What Roles are in PV?
In clinical research, PV operations work with the clinical research team to collect information on a drug’s SAE and ADR. SAE is a serious adverse event. They can be lethal or cause disabilities in the patient or induce birth defects. On the other hand, ADR is an adverse drug reaction, which is a milder adverse reaction to a drug. They include conditions like headaches, nausea, or fatigue.
In addition to data collection, operations are responsible for creating standard operating procedures (SOPs), as well as individual case study reports, literature screening, and regulatory expedited reporting on Suspected unexpected serious adverse reactions (SUSARs), or unknown as unexpected serious adverse reactions, after the drugs are on the market. Those interested in a deeper dive into standard operating procedures and case studies might consider exploring the ICH-GCP course.
The safety data collected by the operations division is maintained by those in the PV systems. They ensure that the data is organized and accessible to research collaborators. The systems team is always working to improve and maintain the vast data, since field regulations and expectations are always changing.
The safety data is then handed to the PV surveillance team. PV surveillance analyzes the safety data and then compiles their analysis into development safety update reports (DSURs). This report determines whether or not the drug is safe enough to move on to the next phase of clinical research. At the end of the third phase, if the drug is safe enough, the PV will submit the drug for FDA approval. Professionals aiming to oversee such critical roles in drug safety might be interested in the Advanced Clinical Research Project Manager Certification.
How Do I Start?
The PV department needs and recruits diverse talents to ensure that a drug is safe. If you can see yourself in one of these positions, then you should absolutely consider a career in PV. CCRPS recently launched our pharmacovigilance course to help aspiring professionals learn about the field and stand out in front of employers. If you want to learn more about pharmacovigilance, please visit our website at CCRPS.Org and chec.
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
What is a Clinical Data Manager?
The goal of all clinical research is to evaluate the effectiveness and safety of medical devices, pharmaceuticals, in-vitro diagnostics devices, and treatments to support market claims or regulatory submissions. For those interested in taking an active role in such vital research, consider the Clinical Research Coordinator course, which provides essential training and certification for coordinators.
A clinical data manager is someone who is responsible for the success of a clinical research project. They manage all aspects of clinical data collection and dissemination. They ensure that clinical trial data are validated, collected, and completed in line with clinical protocols. These protocols are reviewed and approved by the Institutional Review Board (IRB) and Regulatory Agencies. For professionals looking to enhance their skills in this area, the ICH-GCP course offers in-depth training on the international standards governing clinical trials.
Clinical data managers are the keys to successful clinical research. They develop the data collection tools best equipped for the clinical trial process and lead the decision-making process for data collection. To further specialize in the field, consider pursuing the Advanced Clinical Research Project Manager Certification or the Medical Monitor Certification, which are designed to elevate your expertise and career in clinical research management.
Requirements for Data Managers
In this field, education is very critical. Educational foundation in the following fields is highly useful in preparing for a future career as a clinical research data manager:
• Biological sciences
• Statistics Analysis
• Physical sciences
• Clinical Data Collection
• Data management
• Clinical Protocols
SKILLS
As a clinical data manager, you are expected to have leadership skills for training team members, the evaluation of staff performance, and resolution of issues on clinical data collection. In addition, it is important for you to be organized and detail-oriented. You will create and maintain data management plans and case report forms. You will also be responsible for ensuring that all data management activities are completed accurately to be transferred to the statistical analysis team.
Clinical data managers with advanced computer science skills are always in high demand. Technology has been a major game-changer in the field, being able to take advantage and use it efficiently will be a huge plus. You should be similar with the Electronic Data Capture (EDC) systems, which collects long term data.
Salary
The pay for a clinical data manager is $111,679 per year. The income varies greatly depending on the industry. Clinical data managers work both in the public and private institutions: IVD companies, medical devices companies, biotechnology companies, pharmaceutical companies, and clinical research organisations (CROs) are all possible employers. Check here for postings near you.
Take courses from CCRPS and learn more on how to become a clinical research professional.
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What Is a Clinical Research Associate?
Clinical Research Associates are those responsible for the planning, setting up, and coordinating of clinical trials. They provide technical assistance for experiments, make sure that the scientists that are involved in the clinical research trials comply with regulatory standards, and also collect results during the clinical trials. When the trials are over they are also to be involved in the presentation of the results to the public in a manner that is useful and understandable.
Clinical research associates are those responsible for the planning, setting up, and coordinating of clinical trials. They provide technical assistance for experiments, make sure that the scientists involved in the clinical research trials comply with regulatory standards such as ICH-GCP, and also collect results during the clinical trials. When the trials are over, they are also involved in the public results presentation.
The amazing part about being a clinical research associate is that jobs are available for them in both the laboratory and office settings.
SPECIALIZATIONS
They focus on the following:
Designing and implementing clinical research trials
Training staff, which could be enhanced by taking the Clinical Trials Assistant Training course.
Monitoring progress
Screening test subjects
Presenting findings
Helping maintain the database of all clinical research trainees
SKILLS
As a clinical research associate, you should have the following skills:
Communication skills
Science knowledge
Strong mathematics knowledge base
These core skills are what you need in the clinical research profession.
EDUCATIONAL REQUIREMENTS
As a clinical research associate, you should have one of the following:
High school diploma and 6,000 hours of experience.
An associate degree in clinical research fields and 4,500 hours of experience.
A Bachelor's, Master's, or Registered Nurse degree and 3,000 hours of clinical research experience.
You can come from a variety of medical sciences or health-related fields, or from a nursing background as an RN. Courses offered in hospital and clinical related ethics, team management, and research methodologies will be valuable to your education. Consider advancing your career with certifications like the Advanced Clinical Research Project Manager Certification or the Advanced Principal Investigator Physician Certification.
SALARY
The median salary of a clinical research associate boasts of $90,310 annually and it is always on the rise. Plus, there is always a ready market for clinical research professionals.
Explore more about this field with specific courses like the Clinical Research Coordinator training, Pharmacovigilance Certification, or the CRA course. These certifications will equip you with the necessary skills and knowledge to excel in this growing industry.
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
7 Reasons Why You Should Get into Clinical Research
Have you ever thought that there’s a perfect job out there for you, but you just haven’t found it yet? If you are motivated, informed, and interested in a science and medical career, you might have just found your answer. The future in clinical research is bright, and it is one that you will want to be a part of.
The clinical research industry is a highly lucrative and expanding field. The global clinical trials market has been estimated at $80.7 billion in 2024. As the push for new vaccines and therapeutics climbs, the field value is expected to grow even more. Experts predict that the global market will hit $123.5 Billion By 2030.
Contrary to popular belief, working in clinical research doesn’t have to mean you have to stay in a lab. There are demands and opportunities for every skill set, if you know how to find them. Below, I have put together an in-depth guide on why you should get into clinical research.
You like to a job that’s flexible
Don’t like working in a cubical? How about heading to the airport every morning instead? If you like a job that keeps you moving, then becoming a Clinical Research Associate (CRA) might be the right move for you.
CRAs, contrary to what most believe, don’t collect data or interact with patients. A CRA’s job is to travel between different research sites and verify data transcription. They are called “monitors” because it is their job to ensure that every site is following proper compliance and protocols.
There are two types of CRAs: home base and in-house. Home base CRAs work remotely. That means they work and travel from home. If you get tired of working from home, you can become an in-house CRA. In-house CRAs stay in one site and work together with a home base CRA to keep each other updated with what is happening at their site.
You like working with people
Have you ever been told that you are a people person? If talking to new people everyday sounds like something you’d enjoy, you should definitely look into becoming a Clinical Research Coordinator (CRC).
CRCs are the backbones to every project. They conduct patient visits, input source documents into the electronic data capture (EDC), and ensure that every trial is following compliance. They are also responsible for handling regulatory documents and updating the Principal Investigator (PI) with trial results.
CRCs conduct a variety of tasks, all of which impact the progress and development of the trial. Every successful clinical trials team needs a good CRC. So, if you have strong interpersonal skills and know how to stay organized, you will be indispensable.
You are tech-savvy
Are you a self-proclaimed techie? Perhaps you’ve dabbled in coding, pick up computer programs easily, and maybe even have a background in IT. Technology is the future. If you think you have a knack for organizing data, you should look into becoming a Clinical Trial Assistant (CTA).
CTAs, also known as Clinical Research Assistants, manage the Trial Master File (TMF). They file, archive, and maintain trial documents and study files. They are also responsible for closing inquiries from the CRA, as well as providing administrative support to the research team. Every important step in clinical research, pre-clinical research, study startup, site management, needs a dependable CTA.
While most jobs in clinical research require some understanding of technology, it is especially important for the CTA to know what they are doing when it comes to managing trial documents and study files. In addition, it is equally important that the CTA is organized and pays attention to detail.
You like a good salary with room for promotion
Current Salary Data (USA, 2024):
CTAs:
Average salary: Update to $66,007 (according to Salary.com)
Salary range: Update to $57,991 - $73,867 (according to Salary.com)
CRAs:
The salary progression for CRAs with experience (one to two years - $72,358, seasoned - $110,102) and individual contractor CRAs (up to $300,000) can stay as is.
General salary comparison: The point about the average US base salary being $40,000 and CTA/CRC salaries being good for entry-level positions remains valid.
salaries can vary depending on location, experience, and specific employers.
You don’t want to go back to school
In clinical research, experience is often valued over degrees. Rather what you didn’t study in college, hiring managers are more interested in what you have done in the past and how they can integrate you into their company. While graduate programs can help point you in the right direction, you don’t need a master’s degree to succeed in clinical research. In fact, certain positions don’t even require a bachelor’s or associate’s degree.
Applying to CRC and CTA positions are one of the most common segways into higher positions in clinical research. CRCs don’t need a bachelor’s or associate’s degree to get their foot in the door. While both CTA and CRA positions require a bachelor’s degree, they don’t have to be in the life sciences.
One of the best ways to gain experience and stand out from the crowd is to have on-site experience. If you need advice on how, Dan Sfera, the CEO of DSCS CRO Clinical Research Services, recommends getting started by interning or volunteering at clinics and research sites to build connections and experience. Sometimes, the easiest way to get involved is to offer services like patient recruitment and social media management in exchange for opportunities to build your CV. By appealing to a site’s needs, this will help you get your foot in the door and build the connections and resume you need.
Another great way of adding experience to your resume is by training through certification courses. When employers see that you have taken the time and effort to understand how to be the best in their field, they are more far likely to hire you. At CCRPS.org, we offer seven courses and certification trainings to give you an advantage. 82% of our students are hired within the first month of taking the course. We are accredited by the Accreditation Council For Clinical Research & Education (ACCRE) and tailor our course to you. For example we offer special courses for nurses and an accelerated certification + internship opportunity for anyone with minimal or no clinical experience.
You come from a different field
Switching career fields can be nerve wracking. However, it is also an opportunity for you to be a unique candidate. Whether you come from a closely-related background, like medicine or nursing, or something completely different, there are ways you can advocate for yourself in front of employers.
If you already have a background in medicine, your knowledge of healthcare and your passion for patient health will make for a smooth translation into clinical research. In addition, your RN or MD degrees will help you gain a competitive edge and allow you to climb higher positions, such as the PI, who is the primary researcher of an operation.
On the other hand, if you come from a less relevant field, you can still leverage yourself to be exactly what the clinical research field needs. For example, if you are a teacher, your communication and interpersonal skills will be your keys to success. If you are a lawyer, your ability to draft and read papers will far surpass the average candidate. If you studied mathematics, you are a skilled problem solver. If you are a translator, your language skills are valuable and will help you get into roles that require it. In short, whatever skills helped you succeed in your previous positions, you can bring it with you to clinical research.
You want to make a difference in the world
There are two types of people in the world: ones who accept the world as it is, and ones who strive to change it. In the last 50 years, science and medicine have gone through a series of drastic changes. However, anyone who works behind the scenes will tell you that medical breakthroughs are not miracles. Clinical research is the culmination of human effort and intelligence. The fruits and labor of the ever-expanding industry are proof that if enough people care about the world, then they can change it. While there are many good reasons to work in clinical research, if you want the privilege to enrich the lives of others, there is a place for you in this field.
If you want to take a sneak peak at employers and opportunities near you, jobs sites like Indeed are a great resource.
Here are links for aspiring CRAs, for CRCs, and for CTAs. (Note: CTAs are often referred to Clinical Research Assistants, not to be confused for Clinical Research Associates)
Unlocking Your Future in Clinical Research: Discover the Perfect Career Path for You
Take courses from CCRPS and learn more on how to become a clinical research professional.
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Roles And Duties Of A Clinical Trial Coordinator
Roles And Duties Of Clinical Trial Coordinator
A clinical research coordinator or a clinical trial coordinator (CRC) is in charge of managing clinical research at clinical research sites as per the protocol, ICH- GCP, and some other regulatory needs. The function of a study administrator in clinical research is very crucial. All the sites of a clinical trial have one or more study organizers relying on the workload at the research site. The clinical trial coordinator certification is required in such research sites.
The site-level clinical trial can roughly be classified into three stages:
Before starting the clinical trial: In this stage, the study organizer has to collect and finish questionnaires collected from different sponsors and various CROs. Clinical research coordinators also have to collect data from the principal investigator and dispatch them back to the people who had communicated to this site for the study. The sponsors choose locations based on responses submitted in the feasibility questionnaire and finally direct pre-site assortment visits to finalize the plots taking part in the conduct. The sites conducting the research work must have clinical trial coordinator certification to carry on with investigator meetings. These investigator meetings are held at the international level or national level. Before beginning with the trial, the clinical research conductors are usually busy in the submission of various documents to the ethics committee. Besides, subject diaries, investigators CVs, clinical research agreement, signature page of protocol, clinical trial coordinator certification, indemnification letter, insurance certificate, blank CRF's, various study logs, etc. are also required to be submitted. A clinical study organizer plays a vital role in these processes. The site-level can then initiate the clinical trial after getting permission from the ethics committee.
Conduct during the clinical trial: The clinical research conductor must have a good knowledge regarding the study protocol and should have a good idea of exclusion and inclusion criteria by the time clinical research is conducted. The study coordinator needs to have consent informed from the subject represented to do by the Principal Investigators. The study administrators need to collect subject pre-medical records, clinical trial coordinator certification, and according to investigation protocol, the person will have to manage issues programmed visits. Before visiting the item randomly, the clinical research coordinator must check exclusion and inclusion criteria, and after that, the entitled subjects are to be enrolled. After completing all the procedures of the visit, coordinators need to present information in the form of a case report. The clinical study coordinator should keep all relevant data and files up to date. In the next step, the CRC has to calculate the study drug accountability. Interactive web response system (IWRS) and Interactive voice response system (IVRS) are to be conducted to record the subject visit as per study requirements. The investigational product is the most crucial part of a clinical trial, and the study organizer has to reserve the same in the right condition and further maintain the essential temperature logs. Clinical trial coordinator certification is also kept up to record. Coordinators should collect all primary data such as stop and start date, severity, administration route, and consumption of medicine by the subject in case of serious adverse events (SAE’s) or adverse events (AE’s). The study coordinators must look after all central and local lab reports all over the clinical trial and take PI signatures on the news to keep it as a document that the PI reviewed them.
After closing the clinical trial: The study coordinators should check all the documents and clinical trial coordinator certification before closing the clinical trial and there on update all the documents. The Clinical research associate or CRA will review and verify all the materials on the day of closure of the clinical trial. The clinical research coordinator, after that, helps in archiving all the documents at the site, when the verification by CRA is complete. This site further maintains all the study associated records for about 15- 20 years.
So it is clear that the clinical research coordinator plays a crucial role at the site level in running a clinical trial, forming clinical trial coordinator certification, and acts as a connection between EC, investigator site, and the sponsor. All clinical trials have the approval of the present Institutional Review Board. Medical care and decisions are the duty of physicians, dentists, and health care professionals. Every individual working in a clinical trial is certified by experience, training, and education. At CCRPS, we offer both CRC certification and free ICH GCP certification. Check below for our additional articles about CRCs.
Take courses from CCRPS and learn more on how to become a clinical research professional. Explore our Pharmacovigilance Certification to understand drug safety and adverse effects, or our CRA training to delve into clinical research associate roles. Those interested in supporting roles can consider the Clinical Trials Assistant Training. For advanced careers, our Advanced Clinical Research Project Manager Certification and Advanced Principal Investigator Physician Certification provide in-depth knowledge and skills. Also, our Medical Monitor Certification is ideal for those aiming to oversee clinical trials medically.
How To Get Free Online Clinical Research Coordinator (CRC) Training
There are a lot of different types of careers that you can look for these days. One of the most lucrative ones is a Clinical research coordinator (CRC). But what is a clinical research coordinator? A clinical research coordinator follow specific clinical guidelines to conduct clinical trials. This goal can be broken into many different parts and aspects, which keeps the CRC’s job fresh and exciting.
Before applying for your first position, you will need understand the duties and requirements of the role first.
What are the critical responsibilities of CRC?
If you are planning to become a CRC, then you must know key responsibilities such as:
Helping to manage the study.
Maintaining the facilities.
Training to new staff.
Helping in patient enrollment procedure.
Keeping tabs to ensure compliance with government regulations.
CRCs carry out a wide variety of tasks. First, you have to work on-site to study your subject and gather your data. A CRC’s primary role is to make sure that the site’s execution goes on without any hindrance.
Secondly, CRCs might have to take on administrative duties as well. Skills such as decision making, analytical skills and a good knowledge base are critical to success in this field.
If these tasks look daunting, don’t worry. CRCs are essential to any research site, and proper training and education can prepare you for the even most difficult tasks of the job..
Job Requirements
Requirements may vary from one employer to another. Generally, employers will expect a blend of educational qualifications, along with work experience in the clinical research field. In addition, you will have to get a CRC certificate if you want to make your mark in this industry.
Several colleges in the U.S. offer this certificate. All you have to do is attend their programs, whether it is a bachelor’s, an assoicate’s, or a graduate degree program.
In addition, you might also plan to take part in internship programs apart from your clinical research coordinator training to upgrade your resume.
However, a traditional college education can be hard to fit into your schedule, especially if you are juggling a full day with school. For people who need flexibility, online CRC training course can be an affordable and intuitive answer to your problems. At CCRPS, we offer ACCRE accredited courses that are curated by real professionals in the field. You can learn important skills for the field, without sacrificing your freedom and time table. In addition, we offer an education-based internship that can help you get the experience you need to get hired at your first job.
The more you learn about this industry, the more your employment opportunities increase. Check out some of our other articles below to get a better grasp of the field.
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
CITI Clinical Research Coordinator Course
Significance of CITI Clinical Research Coordinator Course
The diseases that impact the world need solutions. To find aid for the physical and mental issues of this generation, the group of experts in the medical field work day and night. However, they can’t do this on their own. They need clinical research coordinators to help them find success. In this article, you will get to know the significance and responsibilities of clinical research coordinators, and why programs like the CITI Clinical Research Coordinator Course are critical to aspiring professionals and the field as a whole.
Who is a clinical research coordinator?
Basically, a clinical research coordinator works with a principal investigator in medical research. The principal investigator is responsible for large aspects of the project, such as securing grants and writing protocols, while the clinical research coordinator is responsible for the day-to-day operations of research. Some tasks include:
Maintaining records and documents
Recruiting patients
Ensuring trials are following protocol
Keeping the principal investigator informed on developments
Managing supply inventory
The clinical research coordinator needs to complete a variety of tasks, but overall they need to have strong communication and organization skills. For those looking to advance in this role, the Advanced Clinical Research Project Manager Certification might be of interest.
More about the Clinical Research Coordinator Course
Being a clinical research coordinator is not easy. Thus, education and re-education is critical to field professionals.
Many different institutes and universities all around the world offer courses, but the CITI clinical research coordinator course stands out. The course is balanced and well-thought out. Students get to learn about ethics as well as the responsibilities of the clinical coordinator. The institutes do not only teach textbook knowledge, but they also encourage practical knowledge. For a comprehensive learning experience, students might consider exploring related certifications like Pharmacovigilance Certification or Clinical Trials Assistant Training to gain insights into different aspects of clinical trials. Those in more specialized roles may find the Advanced Principal Investigator Physician Certification and Medical Monitor Certification to be valuable additions to their educational pathway.
If you feel inspired, check out their course page here. If you want to compare options, try CCRPS. We offer affordable, ACCRE accredited courses dedicated to clinical research coordinators. Similarly, our courses are written by real professionals that know how to help someone stand out in the field. Still not sure yet? Below are some of our articles that will help you better understand clinical research and make an informed decision.
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course