Clinical Research Associate

Job Role:

- To coordinate and conduct the clinical studies for new product in line with SOPs, GCP and applicable guidelines
- Setting up the trial site and Liaising with doctors/consultants or investigators on conducting the trial
- Verify that ethics committee operates and complies as per GCP,SOP and applicable regulatory requirements
- Ethics Committee coordination and prepare documents for getting approval of clinical studies from Institutional Review Boards
- Monitoring the trial throughout specified duration involving monitoring visit to the trial sites.
- Source data verification and periodic review for potential safety issues
- Maintain trial master file at study site and ensure the budget for study participants compensation
- To generate clinical investigation report and clinical evaluation report as per applicable standards
- Clinical evaluation report preparation and review for CE marked products
- Post Market Surveillance activities (PMS, Post Market Clinical Followup and Periodic Safety User Report) plan and report