Clinical Research Coordinator is responsible for conducting trials as per the GCP guidelines under the supervision of the Principal Investigator (PI). Although the PI has the overall responsibility for performing the trial, it has been stated that the CRC is the heart and soul of the clinical trial and that, eventually, it is the CRC who carries ahead the research objectives, in that way playing an important role in the success of the clinical trial. Most significantly, CRCs are usually engaged in vital duties that have been usually carried out by the PI, some of them being the informed consent process and making sure that the site staff is in compliance with the protocol.The CRC’s main responsibility, as with all clinical research staff, is to ensure the protection and well-being of the patients participating in the study. In addition, a CRC has many other duties which include:
- Take part in preparation and control of research budgets and financial payments.
- Notify subjects regarding all study aspects relevant to them.
- Enter study data into the applicable database.
- Keep track of study activities to make sure compliance with protocols and with all related local, state, and national regulatory and institutional polices.
- Manage necessary records of study related activity which includes case report forms, drug dispensation records etc.
- Communicate with laboratories or researchers about laboratory findings.
- Obtain industry-sponsored studies via personal contacts and professional organizations.
- Direct the request, collection, labelling, storage, or shipment of samples.
- Take part in meetings and seminars to update knowledge of clinical research and related issues.
- Enrol subjects in the study as per the study protocol.
- Prepare or get involved in quality assurance audits performed by study sponsors, regulatory authorities, or exclusively designated review groups.
- Prepare advertising and other educational materials and conduct campaigns to enroll subjects.
- Consult with health care experts to figure out the best recruitment practices for clinical trials.
- Arrange space for study equipment and other trial related material.
- Monitor enrolment status of participants and record dropout details such as dropout causes and subject contact efforts.
- Overview proposed study protocols to assess factors such as sample collection procedures, data management issues, and possible subject threats.
- Record adverse event and side effect information and consult with investigators concerning the reporting of events to regulatory agencies.
- Prepare trial-related paperwork such as protocol worksheets, adverse event reports, IRB documents, procedural manuals and progress reports.
- Manage subject registration to make sure that informed consent is effectively obtained and recorded.
- Keep in touch with sponsors to schedule and coordinate site visits or to answer queries.
- Dispense study medical devices or drugs to subjects, determine dosages and deliver instructions as necessary.
Education Required to become a Clinical Research Coordinator
There is no single qualification to become a Clinical Research Coordinator. Accepted qualifications differ by employer, however in general clinical research coordinators are expected to have a science degree with broad clinical research knowledge because of the medical nature of the profession.
Possessing a degree in a medical field, such as MBBS, Nursing and Pharmacy is a great way to get started as a CRC. Graduates with a Bachelor of Science (suitable for entry-level jobs) or a Master of Science (suitable for jobs with more responsibility) in areas such as biotechnology, biochemistry, microbiology and biology are also eligible to work as a CRC.
Graduates from any of the above mentioned areas may want to also pursue a diploma in clinical research, as this training program concentrates on providing students with the knowledge required to get a job in the clinical research domain.
Importance of Clinical Research Training and Certification to Become a Clinical Research Coordinator
Although it is not mandatory to have a certification in clinical research to become a clinical research coordinator, but, certification enables applicants to show that they have met eligibility requirements and have achieved job-relevant knowledge and skills. This is highly important for pharmaceutical companies and contract research organizations that frequently hire clinical research staff.
Who Will Hire Clinical Research Coordinators?
- Pharmaceutical Organizations
- Contract Research Organizations