• Provide GCP and compliance-related audits of internal and external Clinical Studies in process • Support updates of procedures in compliance with applicable regulations • Perform vendor audits as needed • Act as a Clinical Quality Auditor Lead on clinical trials by supporting project team compliance with national and international regulatory standards and guidance for medical devices • Support development of audit management plans and audit strategy for ongoing clinical trials • Conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines and in alignment with internal audit plans • Participate in the development of departmental standard operating procedures, work instructions, forms, and templates • Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented/documented • Support or conduct training for staff (GCP, Inspection Readiness training, etc.) • Support regulatory inspections • Review/revise Standard Operating Procedure (SOPs) and procedures as assigned • Responsible for initial and ongoing audit of clinical study vendors such as CRO, imaging core lab, central laboratory and other vendors as needed • Identifies and escalates site, vendor and study related issues to management, as appropriate