It is the duty of the clinical research coordinator to conduct trials in accordance with GCP guidelines under the supervision of the Principal Investigator (PI). Although the principal investigator is in charge of the overall clinical trial, it has been said that the clinical trial coordinator is the heart and soul of the project and that, ultimately, it is the CRC that coordinates and executes the research. Thus, playing an important role in the success of Clinical Research. The most significant role of CRCs is in ensuring the informed consent process and ensuring that the site staff follows the protocol. The CRC’s main responsibility, as with all clinical research staff, is to ensure the safety and well-being of the participants.
Roles and responsibilities of a clinical research coordinator
A CRC also has many other duties, such as:
- Participate in preparing and monitoring research budgets and financial payments.
- Provide subjects with all study information that is relevant to them.
- Add study data to the applicable database.
- Ensure those study activities are in compliance with protocols and with all local, state, and national regulatory and institutional policies.
- Record all necessary study-related documents, such as case reports, medication records, etc.
- Obtain industry-sponsored studies via personal contacts and professional organizations.
- Samples should be requested, collected, labeled, stored, and shipped.
- Keep up-to-date on clinical research issues by attending meetings and seminars.
- As per the study protocol, enroll subjects in the study.
- Participate in quality assurance audits conducted by study sponsors, regulatory authorities, or specialized review groups.
- Conduct campaigns to enroll subjects by preparing advertising and other educational materials.
- Get advice from medical professionals about the best recruiting practices for clinical trials.
- Prepare space for trial materials and study equipment.
- Observe and record details of dropouts, such as dropout causes and subject contacts.
- Analyze the proposed study protocol to assess factors such as sample collection procedures, data management issues, and possible threats to study subjects.
- Report adverse events and side effects to regulatory agencies by recording and consulting with investigators.
- Preparation of clinical trial-related paperwork, such as protocol worksheets, adverse event reports, IRB documents, procedural manuals, and progress reports.
- Ensure that informed consent is obtained and recorded effectively during subject registration.
- To coordinate site visits and to answer questions, stay in touch with sponsors.
Educational Qualification required to become a Clinical Research Coordinator
Qualifications for becoming a Clinical Research Coordinator are not standardized. Because of the medical nature of clinical research coordinators, employers accept different qualifications. However, in general, science degree holders with solid clinical research training are expected to have the job.
Degrees in medical fields, such as MBBS, Nursing, and Pharmacy, can be useful in becoming a CRC. The CRC program is also open to graduates with a Bachelor of Science in biotechnology, biochemistry, microbiology, and biology (suitable for entry-level jobs) or a Master of Science in biology (suitable for jobs of greater responsibility).
Any graduate with experience in one of these areas may also want to pursue a diploma in clinical research since this program provides students with the knowledge necessary to become involved in the clinical research field.
Salary of a CRC
Initially, a clinical research coordinator earns 2-3 lakh rupees annually but after a certain period of experience and knowledge, the salary increases up to 4-5 lakhs. Also, a CRC gets promoted to a CRA.
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