Clinical research co-ordinator job Profile:
A Clinical research co-ordinator is a person responsible for conducting clinical trials according to ICH-GCP regulatory requirements. The Clinical research co-ordinator is employed by the Principle Investigator and assists in conducting the clinical trials, determines if the research site has the patient population, staff support, medical facilities and equipments necessary to carry out clinical trials.
A Clinical research co-ordinator should devote time to explain the procedures of clinical trial to the study subject. Other responsibilities of a clinical research co-ordinator includes preparation of a case report form, maintains patients previous medical records, records laboratory results, protection of human subjects, preparation of Institutional review board submission, writing informed consent document, subject recruitment, patient care, adverse event reporting, cost analysis and budget negotiation, processing and shipping of laboratory samples ect. Before a clinical trial is closed at the site, clinical research co-ordinator have to check all the documents and the same as to be updated.
Clinical research co-ordinator is responsible for telephonic reminders to the subjects regarding the visits. If the clinical research co-ordinator is involved in the data entry then it is his responsibility to resolve all queries within 48 hours or as per timeline specified by the sponser.
Devoting time as a clinical research co-ordinator and worklife balance is essential because clinical research co-ordinator is a challenging profile, wherein you need to take over multiple responsibilities at a time. Since a clinical research co-odinator is engaged with skillfull individuals, communicating with them can be interesting and motivating. Individuals who are career oriented and seek career growth can opt for being a clinical research co-ordinator because it provides an exciting career.