Job Description

Responsibilities

• Lead/manage Good Clinical Practice (GCP) audits, including clinical investigative site audits, clinical vendor audits, clinical department internal audits, Trial Master File (TMF) audits, and applicable study document audits, including Clinical Study Reports (CSRs)
• Serve as a QA representative and support clinical study teams to provide compliance advice
• Participate in review and approval of clinical study documents and clinical SOPs / Guidance Documents
• Manage study-specific Clinical Study Audit Plans (CSAP) compliance for the assigned program by using a risk-based approach for clinical studies
• Review and approve investigational product (IP) temperature excursions to ensure release or rejection of IP on time
• Lead continuous improvement of the Clinical Quality Management Systems (CQMS) and processes, including creation and revision of SOPs for GCP compliance and excellence
• Manage and support inspection readiness activities for GCP
• Support clinical inspections conducted by regulatory agencies, including sponsor inspections, clinical investigative site inspections, and contract research organization (CRO) inspections
• Support GMP, GLP, and PV inspections
• Lead clinical non-compliance event investigations and CAPA implementation
• Perform quality metric analysis for clinical QA including study quality event trends from clinical process deviations / CAPAs to include a review of protocol deviations, safety, and other clinical data
• Maintain a contemporary knowledge of agency and industry trends, standards, and methodologies as related to GCPs. Maintain the GCP regulatory surveillance program
• Provide cross-training development opportunities to QA team members, and mentor/coach junior QA team members upon request or as an assigned supervisor

Preferred Education & Experience

• BA/BS degree in a relevant field, or equivalent experience
• 6+ years’ clinical research experience
• Understanding of Quality Systems that support GCP quality activities
• Experience with advanced Microsoft Office applications (Word, Excel, PowerPoint)
• Experience developing GCP processes for the best industry practices and training

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