A clinical research coordinator administers clinical trials under following good clinical practice guidelines. They follow the instruction and supervision of a clinical research manager, principal investigator, and medical director. These coordinators work at clinical research sites where they will study their subjects to ensure the successful operation of the clinical trial. They also carry out various administrative tasks that involve analytical skills, good decision-making ability, and a sound knowledge of study-related practices.
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How to Become a Clinical Research Coordinator
The educational requirements from employers vary. However, employers normally require a blend of clinical research education and experience, given the health implication of the job. A clinical research certification or diploma allow clinical research coordinators to show that they have the knowledge needed to do the job.
A number of colleges offer certificates, associates, and bachelor degree programs that equip you for entry-level employment in the industry and prepare you to pass the CRC (clinical research certification) certificate. Other tasks of a CRC may require the completion of a master’s degree. Associate’s degree programs in clinical research cover general education courses together with specific clinical research courses. These programs may require you to partake in an internship program.
If you have medical experience already, for instance if you are a registered nurse, you may only need to attend a certificate program to work as a CRC. However, if you do not have medical experience, you may need an educational program that covers fundamental courses in medical and research terminology and introductory level coursework in clinical research. Some standard courses in a CRC program are:
- Clinical research management
- Drug safety
- Legal and regulatory compliance
- Clinical statistics
- Pharmacology for clinical trials
- Research ethics
Obtaining a CRC Certification
The Association for Clinical Research Professionals (link opens in a new window) offers the certification. To qualify for the ACRP certification, you need to supply a proof of completion of an associate or bachelor’s degree or be a registered nurse (RN). You must also present evidence of work experience of no less than 3,500 hours. You are also good to go if you obtained a high school diploma and have experience as an LVN, LPN, medical assistant, or lab technician in addition to 4,500 hours of work associated experience.
The ACRP also as well offers other certifications like the Clinical Research Associate (CRA) and Clinical Physician Investigator (CPI). Each one of the certifications requires that you fulfill the eligibility qualifications and pass written ACRP CRC Certification examination. The degree of experience necessary will vary and depend on your level of any medical training you have and academic achievements. The Society of Clinical Research Associates (SoCRA) is the body that provides the Clinical Research Professional certification (CRP).
You will only be awarded the CCRC credential as a Clinical Research Coordinator if you have fulfilled eligibility requirements, established your expertise in particular education and job‐related skills, and excelled in the standardized ACRP CRC Certification exam. The CCRC designation officially identifies you as CRC who have fulfilled the professional standards laid down by the Academy of Clinical Research Professionals.
Job Description of a Clinical Research Coordinator
Clinical research coordinators (CRC) prepare, direct, and coordinate clinical trail projects. They would also assign tasks to other members of the research team and ensure they comply with the protocols wet for the clinical trial. From there, they would evaluate and analyze the information that was gained from the trail. A CRC may also find themselves promoting or advertising the clinical trial to recruit participants. Clinical research coordinators would also collaborate with other representatives that offer equipment or software for the trial to ensure all requirements are met.
Patients that would participate in the study and any family would also receive education about the clinical trial and expectations of their participation would be explained. They would also monitor the patient’s progress and evaluate how the clinical trial was going. Because of this, they may schedule appointments to ensure the patient gets regular checkups at specific times during the trial.
There are a host of other tasks a CRC must perform, from setting up the location for the study, ensuring the project stays within budget, and even track participants who withdraw from the program or stop participating. Keep the essential records of the activities carried out during the study is vital, so it is important for the CRC maintain case report forms, records of drugs dispensed, and regulatory forms.
Clinical Research Coordinator Career Video Transcript
Clinical research projects evaluate the safety and effectiveness of drugs or medical treatments. This requires attention to detail, planning, and facilitation. Clinical research coordinators carefully organize clinical studies to produce the most accurate results possible. They maintain critical, legal records of what goes on during studies, including case reports and drug dispensation records. Their data is essential in determining the success or failure of a therapy. These reports may need to be shared with officials or other regulatory agencies.
Clinical research coordinators must exercise clear ethical standards when it comes to screening, monitoring, and directing study participants. They ensure that participants understand and voluntarily consent to a study. Subjects may only participate in a study after a clinical research coordinator interviews them, reviews medical records, and consults with the appropriate medical professionals to ensure it is safe and responsible to do so. They often advise sponsors of the study on procedural issues and may schedule the facilities, as well as analyze the risks of clinical studies.
Many clinical researchers work in research centers, pharmaceutical labs, universities, and large hospitals. Most work full-time and have a bachelor’s degree with a major in a health sciences or related field. Some employers require coordinators to have a registered nurse or licensed practical nurse credentials for these positions.
National Center for O*NET Development. 11-9121.01. O*NET OnLine.
The career video is in the public domain from the U. S. Department of Labor, Employment and Training Administration.