The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI).The main qualification needed is one should be GCP trained and should be of medical or life science background.
While the Principal Investigator is primarily responsible for the overall , conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.
|CRC connected to other departments|
1. Training And Protocol Orientation
Attend sponsor’s study training meeting and develop a comprehensive understanding of the protocol, related schedule of events and procedure for overall compliance
2. Site Organization & Management: (a) Maintain adequate inventory of supplies/IP drug accountability record Help the investigator maintain essential documents at the site. (b)Make sure that all personnel involved in the study are well informed and follow GCP guidelines (c) Make sure that the PI receives all the updated trial related documents (d) Manage the ERB submissions on clinical study up dates/communication by investigator on time
3. Recruitment and Randomisation: (i) Conduct initial in-office interviews of patients for acceptibility (ii) Assess patient interest and protocol understanding (iii) Participate in obtaining the consent of pts. (iv) Randomisation of patients
4. Patient visit scheduling: (i) Schedule the patient visits as per protocol schedule of events (ii)Coordinate patient visit with the physician schedule (iii)Network with the other departments (iv) Coordinate lab sample collection and pickup schedules (vi) Ensure protocol compliance for all events and procedures (vii)Evaluate patient status for safety and assure optimum health care
5. Data Collection, Query Resolution and SAE Reporting: (i)Screen pt. chart to check eligibility (ii) Collect reports from various departments to complete the Source document (iii) CRFs completion (iii)Periodically update all the logs of study file (iv)Collaborate with the CRA (V) Query resolution (vi) SAE reporting on time
6. Audits: Provide assistance for Routine auditing by sponsor and Other regulatory bodies to view
(i) Study records
(ii) Patient filesAll source data of all patients in the study