7 Steps To Becoming A Clinical Research Coordinator
7 Steps to Launching Your Career as a Clinical Research Coordinator
The prospect of a career in clinical research can be exciting, especially for those with a passion for science, medicine, and helping others. A Clinical Research Coordinator (CRC) plays a vital role in this field, ensuring research is conducted ethically and efficiently. If this sounds like the path for you, here are 7 essential steps to becoming a successful CRC:
Earn a Relevant Degree:
A bachelor's degree in a science-related field like biology, chemistry, or healthcare administration is typically required (National Institutes of Health .gov). Some employers may prefer a master's degree for more specialized roles (National Institutes of Health.gov). Consider exploring the Clinical Research Coordinator course for targeted training in this role.
Gain Hands-on Experience:
Internships or entry-level positions in clinical research settings offer invaluable experience (Association of Clinical Research Professionals (ACRP)). This practical exposure strengthens your resume and provides real-world knowledge for future CRC roles. Gain further insights through the Clinical Trials Assistant Training course.
Consider Certification:
While not always mandatory, CRC certification enhances your credentials and marketability. Programs like those offered by the ACRP validate your expertise and set you apart from other candidates. Expand your certification options with the CRA course and the ICH-GCP course.
Develop Core Skills:
Crucial skills for CRCs include: attention to detail, organization, critical thinking, and effective communication. A strong understanding of research regulations and ethics is also crucial. Enhance these skills through the Advanced Clinical Research Project Manager Certification.
Build Your Network:
Attend industry events, conferences, and seminars to connect with professionals. Networking opens doors to opportunities, mentorship, and valuable industry insights. Consider further specialization with the Advanced Principal Investigator Physician Certification.
Apply for CRC Positions:
With your qualifications, certifications, and experience in place, actively seek CRC positions. Tailor your resume to highlight relevant skills and experiences, and craft a compelling cover letter showcasing your passion for research. Research the organization and demonstrate your knowledge during interviews.
Embrace Continuous Learning:
The field of clinical research is constantly evolving. Stay informed about industry trends, participate in continuing education, and pursue professional development opportunities to stay ahead in your CRC career. The Pharmacovigilance Certification and the Medical Monitor Certification can be instrumental in your continuous learning journey.
References:
National Institutes of Health (.gov): https://toolkit.ncats.nih.gov/glossary/clinical-research-coordinator/
Association of Clinical Research Professionals (ACRP): https://acrpnet.org/
Society for Clinical Research Associates (SCRA): https://www.scra.org/
Clinical Research Coordinator Certification
How To Get Clinical Coordinator Certification?
The clinical coordinator or CRC is also known as the clinical trial manager. They play an essential role in the studies of medicine of all types. They work typically under the personal investigator who has a charge of managing and conducting the clinical trial at a higher level. CRC's job is to facilitate, support, and to organize the daily trial activities of the clinical. Getting a clinical coordinator certification online will take a lengthy procedure. There are some kind of the CRC at very different phases of various educational achievements. Let's look at the steps which you will need to get the clinical coordinator certification.
Step 1: Must Be Graduate From High School (4 Years)
For preparing for the clinical coordinator certification, you must begin with high school courses like biology, chemistry, and physics, also with the maths and communications. This will found your form of the foundation which will be pursued for the college studies, which also be the four-year studies.
Step 2: - Obtain A Bachelor Degree Of 4 Years
When perusing the universities and the colleges, you must focus on the courses which offer you a bachelor's degree in health sciences in terms of clinical research administration. The students should dedicate them all the things to obtain this degree and must concentrate only on this for pursuing the degree full time. These programs generally provide the clinical research professional with the tools which they will need to do the developing their medical sciences and conducting their trials and also studies. Both on the campus and the online programs on the clinical administrations focus on clinical research for placing to protect the human subjects.
The bachelor's degree can give you an entry-level position in the clinical organization or any institution. It will also help you with the existing clinicians with the advance, which is in the current jobs. The students who wish to pursue more opportunities in terms of responsibility and also the salary might also be interested in specialized training such as the Clinical Trials Assistant Training or the Advanced Clinical Research Project Manager Certification.
Step 3: - Gain Some Professional Experience
In this step, you will need to gain some experience in the field. You will have to work in clinical research with full-time research. This is the requirements for qualifying the national clinical coordinator certification. For those looking to expand their knowledge in specific areas, consider the Advanced Principal Investigator Physician Certification or Medical Monitor Certification.
Step 4: -Obtain Online
In this step, the students can get an online graduate certificate in the clinical researcher, which can be of 1 year. This will help the students to grow some knowledge around the medical world. It will help the students for getting the clinical coordinator certification. Here you can explore many types of concepts of science and designing research, data management, professionalism, and leadership. This degree will offer you strong knowledge in clinical examination, ethical research and will also provide you the experience of the medical management skill related to drugs and other trials of therapeutic. For those interested in further certification, the ICH-GCP course is also available.
Step 5: - Online Master Of Science In Clinical Research Management
This online Master of Science course is done for increasing the salary purpose of the clinical research. This is a two years course. This course includes the clinical study of coordinators and as well as the data manager of the clinical, research assistants of the social science, and also about the clinical tech laboratories. Here you can explore many types of concepts of science and designing research, data management, professionalism, and leadership. After this course, the students will get some handsome salary and also be eligible for higher-grade jobs in clinical research. This will benefit you is pursuing the clinical coordinator certification. Those interested in Pharmacovigilance may consider the Pharmacovigilance Certification to enhance their expertise in this critical area.
Get The Certification
Now it's the time to hold the accreditation of your hard work, and it determines your success. There are some categories of certifications that will help you to understand which category you fall in.
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.
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
Clinical Study Coordinator Training Program
A study coordinator is the backbone of any research project. They are responsible for ensuring that all the elements of the study further the goals of the study, or the research objective. A study coordinator’s foresight and attention to detail are critical to the success of every trial.
Role Of A Study Coordinator
The role of a study coordinator is broad and includes the following:
In the planning stage: ensure that the plan is comprehensive enough to cover all aspects of the study and that various processes and elements of the study are linked. For those looking to become a study coordinator, the Clinical Research Coordinator course can provide essential training.
At the time of execution: ensure the availability of funds, apparatus, infrastructure, etc. required for the study. Further, they also have to ensure that the study flows promptly. Knowledge of ICH-GCP standards, covered in our certification course, is crucial here.
When various elements of the study are near to completion: the study coordinator will have the role to align them in a planned manner.
At all stages for research: a study coordinator ensures that research ethics are maintained, and there is no violation of any code of conduct.
Determine the Standard Operating Procedures (SOP) to be followed in a study. The Advanced Clinical Research Project Manager Certification can help develop the skills needed to define and manage SOPs effectively.
Work opportunities for a study coordinator
In many countries, such as India, study coordinators are a relatively new career route and hence acutely unexplored. However, considering the growth in research and development areas, it is pretty evident that there is an increasing demand for them. Presently, the industry needs study coordinators while only a handful of them exist.
Due to this demand-supply gap, the monetary compensation of such positions has been very high. Research by Salary.com contends that the median salary of a clinical research coordinator is around $63,330. However, based on the type of study, the range may vary from as low as $2,000 per month to as high as $4,500 per month. Those interested in expanding their career options might consider training as a Clinical Trials Assistant, or specialize further with the Advanced Principal Investigator Physician Certification or Medical Monitor Certification.
Importance
Every field of work needs consistent education, and there's always a scope for enhancement. The area of work of a study coordinator is no exception. The sky is the limit, and each training program is a step towards reaching perfection.
A study coordinator training program focuses on developing individuals to perform the roles mentioned above, in addition to other roles that may be expected from a study coordinator.
For example, regulations and code of ethics governing the respective field of study may also get updated from time to time. In such cases, it becomes necessary for the coordinators to obtain a basic understanding of the changes and implement them in a study.
Moreover, certain organizations may require applicants to have taken certain training courses before considering them for a position. Thus, it has become evermore important for hopeful professionals to take the right training courses.
Who Will Provide The Training?
Depending on the area of study, various institutions, or people with immense experience in the relevant field may provide training.
For example, an organization may organise EA training for its employees from experts in the industry. Other examples of are specialized training courses for coordinators, such as the Clinical Research Coordinator (CRC) training provided by the CITI Program.
Further, various universities run comprehensive and dedicated courses for imparting study coordinator training. Some such institutes are Clinical and Translational Science Institute (CTSI), which provides basic coordinator training, and ACRP, which provides Certified Clinical Research Coordinator (CCRC) training.
Conclusion
The field of a study coordinator is a career that has immense potential yet to be explored. More trained professionals can prove to be very valuable assets to the research processes. At CCRPS, we offer ACCRE accredited training specialized for study coordinators. In addition, we have complied articles below to help you better understand the complex aspects of clinical research.
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
How to Save Money on Becoming a Clinical Research Coordinator (CRC)
If you think practically, then you will find that nothing in this world comes for free. But if you have a passion for clinical research and need to learn on a budget, here are some ways you can enhance your understanding without breaking the bank.
To understand how you can learn for free, it’s first important to understand the typical trajectory of a clinical research coordinator:
A person seeking clinical research coordinator training should complete high school. There they learn must-have all the science subjects like physics, chemistry, and biology.
After high school, institutes for professional clinical research coordinator professionalism offer programs that are essential for later.
In addition, one can get an experience graduate certificate from an online source. This would help the person reach their career goals faster.
Alternatively, they can complete a bachelor's degree of science.
After completing the bachelor's degree, a master's degree is needed for some of the higher pay-grade positions.
How to get free clinical research coordinator training?
If looking at the education requirements for a clinical research coordinator makes you dizzy, you’re not alone. Becoming a clinical research coordinator takes a lot of time and money. That is why many students turn to scholarships and healthcare programs to help pay their tuition.
On the other hand, there are many websites that offer free or affordable information and training for aspiring professionals. While they can’t replace a formal education, they can supplement your resume and knowledge. While some important topics include clinical data management, pharmacovigilance, and regulatory authorities, you should strive for a comprehensive understanding of the field. At CCRPS, we offer affordable courses designed for clinical research coordinators as well as free ICH GCP training. These can help you build your resume and land the position you want.
In addition, it is really important to keep updated with new clinical research headlines. Below, I have complied some articles that aspiring professionals might find useful. The best thing you can do for your education is to start now and not later.
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
How to Make a Career out of Clinical Research Management (CRC)?
A clinical research coordinator or CRC is a highly trained professional, whose expertise is crucial to all medical research work. Although a CRC works under the constant guidance of a principal investigator, they are responsible for the day to day trials and clinical operations. Thus, this profession can be quite challenging but rewarding.
However, getting into the crew of CRCs is not an easy task. A particular individual may need to prepare for a while to be selected for such a post. In this segment, you can learn all the aspects to becoming a successful CRC.
What does a Clinical Research Coordinator do?
A clinical research coordinator or CRC is a highly trained professional, whose expertise is crucial to all medical research work. Although a CRC works under the constant guidance of a principal investigator, they are responsible for the day-to-day trials and clinical operations. Thus, this profession can be quite challenging but rewarding.
However, getting into the crew of CRCs is not an easy task. A particular individual may need to prepare for a while to be selected for such a post. In this segment, you can learn all the aspects to becoming a successful CRC through specialized training such as the Clinical Research Coordinator course.
What does a Clinical Research Coordinator do?
The field of medicine is always advancing. In the world of medicine, new knowledge is indispensable. So, the professionals of the medical branch are always looking to conducting experiments that can lead them to new cures and successes. Among clinical research professionals, clinical research coordinators are at the front lines of research operations and analytics.
The duties of a CRC are to plan and initiate a study or experiment the board has approved. During the phases of the project, they must maintain communication between their site and institutional organizations. The CRCs are eligible to do the research and reviews. Additionally, they can choose to hire potent candidates for their purpose. Understanding and adherence to ICH-GCP guidelines are crucial for ensuring compliance and ethical conduct in their studies.
How can you be a successful clinical research coordinator?
The job of a clinical research coordinator is not an easy one. However, with enough hard work and patience, one can become eligible for the post. Although, individuals who aspire to become a clinical research coordinator are advised to understand the basics and keep educating themselves if they want to become a trusted professional. Continual education and certification, such as the Pharmacovigilance Certification and Clinical Trials Assistant Training, can provide essential knowledge and skills required in this evolving field.
Additionally, for those looking to further their careers, the Advanced Clinical Research Project Manager Certification and Advanced Principal Investigator Physician Certification are excellent resources to consider. Those interested in overseeing clinical trials and research safety might consider the Medical Monitor Certification.
Here are the requirements to become a successful clinical research coordinator:
1. To apply for this post and profession, the candidates need to have a background that is related to the field of medicine or biology. The general preference for applying is to have a bachelor's degree in microbiology or medical technology.
2. Some positions require individuals who have a master’s degree on top of their bachelor’s degree. So, you might need to invest more time into your education if you want to work with certain firms or reach a higher pay-grade.
3. Preparing yourself for the job is crucial. As this job is a challenging one, individuals might need to develop and train themselves for quite some time to do well. For young training candidates, clinical trial coordinator training is shown to be quite a useful resource. At CCRPS, we offer affordable training courses developed by real professionals and accredited by ACCRE. If you are looking to learn more about clinical research and specific positions, CCRPS can be the perfect starting point.
A step towards the development of humankind
Medical science has experienced great expeditions over the past few decades, and all of that has help benefit society in some way or the other. Thus, becoming a part of a research team is a commendable task indeed.
Becoming a clinical research coordinator isn’t easy. A CRC must have an eye for detail and need to continually polish their skills. Moreover, experience and education is a determining quality that can set a good CRC apart from the rest in the lot. If you’d like to start your education, check out CCRPS. Our courses and articles will help you find the tools to succeed in clinical research.
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
Clinical Research Project Manager
Clinical Research Project Manager - A Full Guide To Becoming a Clinical Trial Project Manager
As of mid-April 2022, top recruitment platform ‘indeed.com’ lists 6,026 openings for Clinical Research Project Managers across the United States[1]. According to ‘payscale.com’, remuneration for this profile ranges from $84,168 for early-career to $120,501 for experienced Clinical Research Project Managers, with a mid-career median of $107,649[2].
A Clinical Research Project Manager (henceforth CRPM) is also known as a Clinical Research Manager or a Clinical Trial Manager. The role of a CRPM is to provide leadership during the clinical trial of new drugs, with the overarching goal of ensuring that the clinical trials process is completed within the stipulated time-frame and allocated budget, while maintaining the highest standards of research quality and scientific integrity.
An overview of the CRPM profile
A Clinical Research Project Manager is the liaison between the study sponsor and the clinical research team. Thus, the CRPM must balance the expectations of the funding organization in a clinical research study (pharmaceutical company, governmental agency, university research division or other entity) with the needs of the team, including Principal Investigators (PIs) and co-PIs, Clinical Research Coordinators (CRCs), Clinical Research Associates (CRAs), and Clinical Trial Assistants (CTAs) and other site staff.
The CRPM plays a leading role in planning, implementation and ongoing monitoring of live clinical trials. In the process, a CRPM also mentors junior team members, including CRAs and CTAs.
Evidently, a career as a CRPM is rewarding, but also demanding. So, what does it take to qualify and be recruited as a Clinical Research Project Manager?
The road-map to becoming a CRPM
Even if you’re new to the field of clinical research, you’ve probably guessed by now that becoming a Clinical Research Project Manager takes both qualifications and experience. A typical CRPM has a bachelor’s (or master’s) degree in life science, combined with four to five years’ experience in one or more clinical research roles such as CRC, senior CRA or QPPV (Qualified Professional in Pharmacovigilance).
Irrespective of where you are along this path, the remainder of this article charts a clinical research professional’s journey of growth in developing into a competent CRPM. For conceptual convenience, the process is discussed in two parts – Part 1 centers on the research and administrative skills needed for a CRPM, while Part 2 revolves around expertise in project management. The final sections address how the Advanced Clinical Research Project Manager Certification or ACRPMC facilitates the transition to a CRPM role.
The CRPM journey, Part 1: Research and administrative skills
By the time a clinical research professional is eligible to apply for a CRPM position, s/he has typically developed a range of competencies in the day-to-day running of clinical trials. In addition, a professional at this stage has usually acquired a good working knowledge of the planning and oversight required for a clinical research study.
In broad strokes, a CRPM candidate likely already has a knowledge base and skill sets in the following areas:
1. ICH-GCP guidelines, Title 21 of FDA CFR and IRB compliance
One of the first things every clinical research professional learns is the importance of adhering to the principles and policies of good clinical practice, as outlined in the ICH-GCP[3]—these guidelines set the framework for carrying out research in a manner that prioritizes the safety and welfare of human subjects and the quality and integrity of clinical data.
The ICH-GCP principles are mirrored by Title 21 within the US FDA’s Code of Federal Regulations (CFR)[4]. Clinical research across the US must conform to the requirements of Title 21. Part of Title 21 regulatory compliance requires nearly all clinical research studies to first be approved by an Institutional Review Board or IRB (also called an Ethics Committee). As clinical trials progress, any changes to the study trial protocol, consent procedures or data management system must likewise first be reviewed and approved by the IRB.
The CRPM has final responsibility for ensuring that all documentation necessary for clinical research regulatory compliance is maintained and updated as needed.
2. Clinical trial design concepts and parameters
A sound grasp of the clinical trials process is similarly a must for senior professionals in the team. Candidates for CRPM positions are thus expected to have a thorough understanding of key concepts and procedures relating to clinical research, including:
Phases 1 to 4 of clinical trials[5]
Investigational products (IPs) including INDs and IDEs
Design concepts in clinical trials - control, randomization and blinding
Subject screening and selection, retention and study compliance
Trial data input, quality assurance, analyses and reporting
Adverse Event (AE) documentation and reporting
3. Pre-trial preparation
In some ways, the most crucial phase of a clinical trial is the preliminary or preparatory phase, during which all groundwork must be laid for the smooth and efficient conduct of the actual study. This phase must typically achieve the following objectives:
Complete documentation for initiating clinical trials[6] – An IRB-approved clinical trial must have in place a host of documents covering important aspects of the study, including the investigator brochure (IB), trial master file (TMF), informed consent form, case report form (CRF), subject recruitment notice, laboratory protocol, study financial projections and so on.
Identification and preparation of study site(s) – Most clinical research studies are run across multiple sites, which may be hospitals, clinics or other health-care facilities. Identifying suitable sites, establishing collaborative agreements with site administrators, as well as setting up the required infrastructure to carry out trials at each site is crucial in preparing for a clinical research study.
Pre-trial publicity – The success of clinical trials depends on gathering large amounts of data from human subjects. Therefore, creating public awareness and interest right from the outset is critical to running clinical research studies effectively.
When setting up a study, the CRPM plays a central role in initiating and fulfilling each of the goals outlined above. Under the CRPM’s guidance, clinical research administrative staff including CRCs and CRAs work to put relevant documentation in place, prepare study sites and create public awareness about the study.
4. Active trial administration
The day-to-day running of an active clinical trial involves numerous administrative components, including:
hiring and training staff at clinical sites
tracking subject recruitment and retention
regulatory compliance in trial protocol, subject safety and data quality
Adverse Event (AE) documentation and reporting
oversight of trial drug storage and use
coordination among research teams across sites
tracking study finances
communication between study sponsors and clinical staff
electronic data capture (EDC) and management
timely renewal of necessary financial and regulatory approvals
These tasks are distributed among members of the investigative teams (PIs, co-PIs and other medical personnel) as well as administrative teams (CRAs, CRCs, QPPVs and other site staff). However, the CRPM is ultimately responsible for ensuring efficient administration that keeps the clinical trial on track.
5. Study termination procedures
Winding up a clinical trial similarly entails a number of administrative exercises. Here again, the CRPM must oversee execution, guiding team members in completing tasks on schedule and to the required standard:
site close-out (relieving staff, subject debriefing, equipment surrender)
final data consolidation and scrutiny
study completion documents for regulatory compliance
compilation of briefs and reports for regulatory authorities, study sponsors
The CRPM journey, Part 2: Expertise in project management[7]
Most aspirants to CRPM positions have usually been engaged in the clinical research process for at least a few years. Many have played administrative roles, working as CRCs, senior CRAs, QPPVs or site managers. In some cases, CRPM aspirants have clinical backgrounds, with expertise in drug research or medical monitoring.
Despite their hands-on experience with the clinical trials process, professionals wishing to transition to CRPM roles usually have limited exposure to the higher-level project management knowhow that is essential for an effective CRPM. This section provides a brief overview of the major project management domains relevant to clinical trial management:
1. Project and operations planning
A clinical trial is a major operation, involving a range of geographical and health-care settings, multi-disciplinary teams, as well as a complex array of regulatory and logistical requirements. Planning the stages, milestones and operations of a clinical trial is integral to assuring its success. Therefore, project and operations planning are the top priorities of a CRPM.
Some of the key elements involved in planning a clinical trial include:
Compiling a comprehensive study protocol describing the rationale, aims, design and methodology, data analysis plans, and trial procedure (/protocol)
Setting project goals, deliverables and milestones
Outlining a project personnel schematic that delineates team and sub-team structure and defines individual team member roles
Generating a responsibility blueprint with a clear break-up of tasks, targets and time-lines for each project goal and each team member
Creating a communication plan that outlines the method and schedule for relaying information, updates and requests between and within teams
2. Financial forecasting and tracking
One of the biggest challenges confronting a CRPM is keeping the trial within budget, while making sure that resources are optimally allocated to cover all necessary project-related expenses. Clinical trials often suffer from scope creep, that is, the inclusion of additional goals and deliverables to those originally outlined, resulting in the project overshooting budget and time-line.
It is therefore recommended practice for a CRPM to work with study sponsors and senior team members in compiling a budget management plan at the very outset of the project. Such a plan not only specifies financial outlay for each of the goals and deliverables of the clinical trial, it also provides for periodic budget revisions to account for factors such as expanded project scope, rising costs and supply-chain changes.
3. Human resource allocation and oversight
The section on project and operations planning highlighted the importance of creating a personnel schematic as well as a responsibility blueprint at the start of a clinical trial. Through this process, a CRPM is able to clearly define roles for various team members in meeting project goals and milestones, and their contributions to each project deliverable.
However, in order to ensure collaborative effort and a cordial work environment, it is essential for a CRPM to also formulate a transparent hiring policy as well as disciplinary policy. These may be specific to the clinical trial or apply broadly across the CRO, or Clinical (/Contract) Research Organization. Well-documented policies facilitate the CRPM’s role in sourcing and motivating the best-fitted staff to play different roles in the clinical team.
4. Clinical data management and quality control
The data from a clinical trial are often its most valuable project outcome. As such, effectively managing the input, storage, analysis and quality control of study data is one of the foremost responsibilities of a CRPM.
Before beginning the active phase of the clinical trial, a CRPM coordinates with team members to put in place the following aspects of data management:
physical data storage system (files, binders, shelves, cabinets, etc.)
electronic data capture (EDC) and management system
physical and electronic data security systems
data input procedure
data cleaning and quality monitoring procedure
data sharing (import, export, access across clinical sites and teams)
data analysis and visualization procedure
periodic data review and reporting procedure
5. Risk management and mitigation
Owing to the high stakes nature of clinical research, running a clinical research study carries numerous risks. One of the major responsibilities of a CRPM is to develop a risk management plan to identify and circumvent potentially risky situations, and to mitigate consequences to the project in cases where an unforeseen risk impacts the trials process.
Some sources of risk in the management of a clinical trial include:
failure to obtain or document subject informed consent
errors in following trial protocol (timing, dosage, subject screening, etc.)
data security breach leading to compromised subject confidentiality
inadequate insurance coverage for potential adverse events of study
financial constraints arising from changes in study funding
limitations on study scope due to revisions in regulatory policy
Bridging the gap: Using ACRPMC to transition from clinical research professional to project manager
The foregoing section outlined how, despite their strong base in clinical research, CRPM aspirants generally lack the advanced knowhow and managerial skills required for leading a clinical research project. CCRPS’ Advanced Clinical Research Project Management Certification (ACRPMC) provides an excellent tool for bridging this gap and bringing candidates up to speed in all domains of clinical research management.
The table below offers a summary of the focus areas of the ACRPMC, detailing how each contributes to enhancing a candidate’s expertise and eligibility for the role of a Clinical Research Project Manager.
ACRPMC Focus Area |
Contribution to CRPM Candidate Eligibility |
ADVANCED REVIEW - I: Regulatory compliance in clinical research |
i.Fundamentals of subject (/patient) safety, ICH-GCP E6, Sections 2 - 4 |
ii.Regulatory compliance – FDA-CFR Title 21, Forms FDA 1571, 1572, 3454, 3455 |
|
iii.Investigational New Drug (IND) & New Drug Application (NDA), Investigational Device Exemption (IDE) |
|
iv.IRB, Data Safety Monitoring Board (DSMB)[8] |
|
ADVANCED REVIEW - II: Clinical trial concepts |
i.Process & phases of clinical testing (pre-clinical and phases 1 to 4) |
ii.Importance of ‘control’ in testing[9], outcome validity, control methods (randomization, blinding) |
|
iii.Subject (/patient) selection[10]: screening & exemption criteria, selection & retention, study compliance |
|
iv.Clinical trial data management[11]: EDC, Clinical Trial Management Systems (CTMS), Interactive Response Technology (IRT), Randomization & Trial Supply Management (RTSM) |
|
v.Subject safety[12]: Risk assessment & Individual Case Safety Reports (ICSRs), Adverse Events (AEs), Adverse Drug Reactions (ADRs), Important Medical Events (IMEs) |
|
ADVANCED REVIEW - III: Pre-trial preparation |
i.Documentation[13]: Regulatory binder, Investigator Brochure (IB), Trial Master File (TMF), Case Report Form (CRF), Delegation of Authority Log (DOAL), etc. |
ii.Site preparation[14]: Site Selection Visits (SSVs), Site Qualification Visits (SQVs), site management agreements, investigator selection |
|
iii.Pre-trial publicity: Advertisement for subject recruitment & retention |
|
ADVANCED REVIEW - IV: Active trial management & trial termination |
i.Clinical trial protocol compliance, deviations & violations |
i.Clinical site monitoring: subject safety, drug storage & safety, regulatory compliance |
|
ii.Data monitoring: data security & access, Quality Management System (QMS), Quality Control (QC), Key Quality Indicators (KQI) |
|
iii.Team monitoring: communication & collaboration, adherence to trial & safety protocols, research integrity & fraud |
|
iv.Reviews & audits[15]: document & site audits, data audits, financial audits |
|
v.Study termination: site close-out visits, data consolidation, subject debriefing |
|
EXPERTISE BUILDING - I: Clinical project management fundamentals |
i.Project management basics[16]: key concepts, Project Management Body of Knowledge (PMBOK) |
ii.Skills of a project manager: technical, administrative, human resources, public relations |
|
iii.Clinical project stakeholders: sponsors, IRB, investigative & administrative staff, site administrators |
|
EXPERTISE BUILDING - II: Advanced clinical project management |
i.Project planning & tracking, progress evaluation metrics |
ii.Financial management[17]: project budgeting, site budgeting, advertising budget, payment tracking and management |
|
iii.Risk management & problem solving[18]: problem solving managerial skills, identifying risks, avoiding failures, resolution of project problems (protocol deviations, compliance failures, project delays) |
Fast-track to CRPM with the ACRPMC advantage
From the above summary table, it can be seen that the ACRPMC[19] program of CCRPS covers the entire spectrum of competencies required for managerial clinical research professionals. In addition to providing in-depth training in clinical project management concepts, tools and techniques, the program includes a review of foundational as well as advanced knowledge of the clinical trials process.
Aside from its comprehensive curriculum, certification through ACRPMC offers major benefits over conventional clinical research management courses, both online programs as well as those offered by colleges and universities. Some of the outstanding advantages of ACRPMC are:
1. Foundational review plus advanced training
The ACRPMC program stands apart from other online programs in its unique ability to launch as well as advance careers in clinical research. The program is equally effective at helping an aspiring graduate (BA in science or BS degree) to gain a competitive advantage in the clinical research job market, as it is at catapulting a senior clinical researcher into a managerial position.
For CRPM aspirants in particular, the ACRPMC provides an unrivaled opportunity to brush up on the basics, in addition to acquiring valuable knowhow in clinical research project management, before embarking on the applications and interview process.
2. Over 100 training modules (250 hours of coursework)
The course comprises over 100 modules. The advanced review focus areas address all aspects of the clinical research process, including important investigative concepts (trial design, randomization, subject screening, data analysis, etc.) as well as administrative processes (maintenance and updating of regulatory documents, case reports, trial logs, etc.). Additionally, the expertise building focus areas of the ACRPMC cover basic and advanced project management concepts and skills that equip candidates to tackle the challenges of leading a clinical research study.
3. ICH-GCP E6R2 compliant
Designed by experienced Clinical Research Project Managers, the ACRPMC curriculum is fully compliant with the regulatory requirements of the ICH-GCP E6R2. The course coordinators additionally ensure that the content is regularly updated to reflect revisions to policy and new requirements.
4. Immediate enrollment and fast-tracked certification
Unlike college and university courses, trainees can enroll in the ACRPMC with just a few clicks. In addition, the self-paced course design allows students to skim through familiar topics, while giving more time and attention to new material. This is especially advantageous for working professionals and senior clinical research professionals wishing to refresh their knowledge. Trainees able to dedicate several hours per day to the program can complete the ACRPMC in as little as two weeks.
5. Multiple accreditations and industry-wide recognition
For ACRPMC-certified trainees, the solid credentials of the program confer a huge benefit when applying and interviewing for clinical research positions. Like other CCRPS courses, the ACRPMC is also accredited to ACCRE (Accreditation Council For Clinical Research and Education), ACCME (Accreditation Council for Continuing Medical Education) as well as ACPE (Accreditation Council for Pharmacy Education).
6. Clinical research résumé building and interview preparation
The final modules of the ACRPMC help trainees in building their ability and confidence to face interviews for clinical research positions. Trainees completing the comprehensive final examination not only have immediate access to a digital certificate, but are eligible to receive a letter of recommendation (LoR) that can strengthen their clinical research job application.
As the clinical research industry continues to grow at an unprecedented pace, there is rising demand for Clinical Research Project Managers who can blend their skill and experience in clinical research with savvy, expert project management abilities. As a professional clinical researcher, the ACRPMC program offers you an unmatched opportunity to refresh existing knowhow and acquire new competencies, thereby leveraging your rise to the top echelons of management.
If you are a fresh graduate, the ACRPMC represents an unequaled, early-career edge in the clinical research arena. By equipping you with foundational as well as advanced knowledge and skills, ACRPMC certification does not merely improve your chances of securing an attractive clinical research position, it assures the rapid upward growth of your career graph.
Advanced Clinical Research Project Manager Certification (ACRPMC) program advantages.
References
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https://app.ccrps.org/courses/Advanced-Clinical-Research-Project-Manager-Certification
