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