Clinical Research Coordinator

1 week ago

Mumbai Maharashtra, India IQVIA Full time

Conduct site/trial feasibility to identify & select the right site and investigator for the study Ø
Ensure timely compilation of all essential documents & assist in regulatory package preparation, timely submission, follow up with site EC to resolve any queries, and obtain approvals Ø Ensuring site setup according to protocol, review patient data base & pre-screening, identify physician network Ø Coordinate for Clinical Trial Supplies receipt, accountability & storage Ø
Prepare site team for study initiation visit and coordinate with monitor for the visit Ø
Assist in the process of administering the informed consent to the potential objects and discussing in detail the patient information sheet Ø
Ensure that site documentation remains current, accurate and complete Ø
Coordinate for lab samples collection and logistics; review of lab reports and update PI Ø
Review & implement appropriate recruitment/referral activities for active enrolment at sites Ø
Ensure CRF Completion and query resolution on specified timelines Ø
Coordinate in conduct of monitoring visits and audits (Internal or External) Ø
Ensure that monitoring/audit related findings are resolved within the timelines Ø
Ensure patient follow up visit and visit compliance; manage patient related reimbursement; site related payment Ø Drug receipt, accountability, storage, dispensing and related documentation Ø
Ensure adherence to protocol guideline, regulations, ethical guidelines Ø
Coordinate and ensure timely reporting to all stakeholders Ø Maintain study log(s) & study manuals Ø
Assist monitor with the site closeout activities Ø
Manage final reconciliation of Clinical Trial Supplies and archival of study documents at sites

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