Develops the requirements necessary for attaining and maintaining compliance with the FDA and other regulatory bodies for clinical trial research both from a documentation and process level based on best practice standards. Creates and delivers educational sessions that promote adherence P guidelines, ensuring that data reported is accurate. The Sr Research QA Analyst leads the team with pharmaceutical audit preparations and audit responses. Performs eligibility verifications and chart reviews. Assists with the coordination of audits. Research QA Analysts are an integral part of the infrastructure development and help to coordinate projects, and communicates status and improvement areas to leadership. Implements and coordinates department-wide initiatives such as research quality management or clinical trial education efforts. The Sr Research QA Analyst works with the QA Manager to develop metrics for reporting to senior leadership and delivers metrics in standard timeframe.

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