PFC Pharma Focus India

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