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

Clinical Research Associate