Responsibilities for clinical research associate
- Develops and disseminate Requests for Proposals from Service Provider’s and will manage Service Providers including training and oversight, and serves as the primary point of contact for SPs
- Draft and coordinate the review of study-related documents including protocols, informed consent forms, case report forms, monitoring plans, investigator brochures, and clinical study reports
- Maintain program timelines, develops study budgets, and coordinates review of data listings and prepares interim/final clinical study reports
- Contribute to development of abstracts, presentations, and manuscripts and may contribute to the development of clinical trial management best practice processes and SOPs
- Write protocols, amendments, case record forms, clinical reports and other documents relevant for dedicated clinical investigations
- Assists the study team(s) to deliver the clinical study within agreed timelines
- Assists in authoring/contributing to clinical study documents and study related plans developed by Clinical CROs and vendors
- Provides oversight of Clinical CRO Investigator background checks
- Assists in oversight of vendor shipment of clinical supplies
- Provides oversight of Essential Documents for Investigational Medicine Release as per relevant SOP
Qualifications for clinical research associate
- Support site identification, selection, recruitment & qualification, and initiation
- Reviews Clinical Monitoring Reports and correspondence related to Pre-Study and Initiation Visits and follows-up with Clinical CRO to resolve open action items
- Manages escalation of study related issues and communicates as appropriate with Clinical Project Manager
- Responsible for the operational oversight of the Clinical CRO with regards to data feed setup in the Clinical Trial Management System
Pay: ₹30,863.00 - ₹45,309.65 per month
Benefits:
- Flexible schedule
- Paid sick time
- Provident Fund
Work Location: In person
