Clinical Research Associate
•Implement and monitor clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines•Assess the qualification of potential investigative sites, initiate clinical trials at investigative sites, instruct site personnel on the proper conduct of clinical trials. Review and verify accuracy of clinical trial data collected.•Provide regular site status information to team members, trial management, and update trial management tools. Complete monitoring activity documents as required by obligations.•Work closely with other clinical team members to facilitate timely resolution of trial and clinical issues. Performs source document verification and query resolution.•Verify clinical trial reporting according to trial specifications and ICH-GCP guidelines. Communicate with investigative sites. Update applicable tracking systems. Ensure all required training is completed and documented.
