Clinical Research Coordinator

Role & responsibilities

• Assist in the compilation of the study related documents during the pre-trial period
• Assist site investigator with EC submissions, follow-up & approvals
• Ensuring site setup according to protocol
• Update investigator with all study related activities performed
• Coordinate subject visits
• Fix appointments for scheduled and unscheduled subject visits as per protocol after prior discussion with

site investigator

• Explain study and related procedures/requirements to subjects
• Resolving subjects non medical queries
• Assist in the process of administering the informed consent to the potential Subjects and discussing in

detail the patient information sheet

• Ensure that site documentation remains current, accurate and complete
• Ensure that required documentation is filed properly
• Ensure that reconsenting is done on time if and when applicable
• Guide subject on requirements of various site visits
• Remind subject on next follow up visit.
• Drug receipt, accountability, storage, dispensing and related documentation
• CRF Completion and query resolution on specified timelines
• Accountability of ancillary supplies and ensure to re-order them as and when required
• Maintain study log(s)
• Maintain study manuals
• Ensure to complete the documentation of Pregnancy/AE’s/SAEs and report to Safety and Medical

Monitor within timelines

• Compile and update the Trial Master File
• Follow up and coordinate with CRA/CRO
• Coordinate in conduct of Monitoring visits and Audits (Internal or External)
• Ensure that monitoring/audit related findings are resolved within the timelines
• Assit monitor with the site closeout activities.

Preferred candidate profile