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

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