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Unterschleißheim - CRA THV

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Unterschleißheim - Medizintechnik - Supervisor - Edwards Lifesciences

Major Job Functions: Supervises the team of Clinical Research Associates at sites in EMEAC and ensure the Study quality according to the prescribed Monitoring Plan and Protocol.1. Supervises CRAs and Monitors,2. Provides guidance and training for CRAs and Monitors,3. Accountable for meeting and reporting on agreed clinical milestones for assigned clinical sites4. Responsible for clinical site AUDITING and provides feedback on : a. Site selection, Site initiation processes, Source data verification, CRF design and review, Query/discrepancy management and resolutions, Adverse event reporting, Deviation reportingb. Reinforce CRA presence to maintain contact with key institutional departmentsc. Problem solving at sites to assure clinical quality and conduct at sited. Visit and report writing for study site includes Auditing visit reports & follow-up with site and study managemente. Communication to study management on changes in legal or regulations for conduct of the study at site and supporting site and study management with audit preparationf. Ensures site audit readinessg. Tracking CRA progress at site; including legal & regulatory deliverables, data quality (e.g. queries, adverse events, deviations)5. Support or manage monitors in their interactions with Ethics Committee and Com ...


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