Job Opportunities

Senior Clinical Safety Associates at HCRI are responsible for:

• Triaging, collecting, monitoring, processing, and distributing adverse event reports (serious and non-serious Adverse Event(s) to the sponsor or regulatory authorities and project team within the specified timelines
• Perform all data entry functions required for the safety database.
• Provide coverage for serious adverse events reported during non business hours, weekends, and holidays on rotational basis, as required by assigned protocols. 
• Generate queries related to serious and non-serious Adverse Event reports.
• Code adverse events using the standardized MedDRA dictionary. 
• Aide the project team in the preparation of all customized and other regulatory safety reports (i.e. DSMB and Annual Reports).
• Perform comparative review and reconcile all serious adverse events between the Clinical and Safety databases.
• Coordinate with the assigned Clinical Reviewer for the adjudication of Mace and/or endpoint events that require CEC adjudication.
• Under the direction of the Medical Director/Manager review new protocols and CRFs for upcoming trials.
• Under the direction of the Medical Director/Manager serve as the primary contact on the project team for assigned trials.
• Perform other safety-related tasks as necessary.