QC Auditor II Full-time Job

Responsible for reviewing clinical protocols, clinical study reports, publications, written summaries, amendments, narratives, appendices, and pharmacokinetic reports for accuracy and consistency and provides review comments and documentation to the Writer. In addition, proficient in reviewing high-complexity and data-rich documents

Ensures consistency and accuracy of all regulatory documents such as written summaries, clinical study reports, protocols, amendments, narratives, pharmacokinetic reports, publications, and appendices to source documents, regulatory agency guidelines, and client requirements. Collaborates with writers to discuss discrepancies, omissions, and errors. Participates in staff meetings, client meetings, and project team update meetings as appropriate. Assists in team reviews. Creates or maintains job aids and completes applicable review checklists. Proficient in reviewing the accuracy and consistency of high‑complexity and data‑rich documents; e.g., documents based on a trial featuring multiple criteria for evaluation, numerous unique cohorts of subjects, and/or a multitude of differing endpoints.

Performs other duties as assigned by Manager or Supervisor

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