Clinical Research Chart QA/Auditor

Key Responsibilities

• Conduct internal and external audits of clinical trials, vendors, and systems to ensure compliance with FDA regulations, ICH-GCP, and company SOPs.
• Prepare, execute, and document audit plans, reports, and follow-up activities.
• Assess clinical sites, CROs, and vendors for regulatory compliance and data integrity.
• Identify gaps, risks, and areas for improvement; provide actionable recommendations.
• Support inspection readiness activities and participate in FDA inspections as needed.
• Review CAPAs for adequacy, implementation, and effectiveness.
• Collaborate cross-functionally with clinical operations, regulatory, and quality teams.
• Maintain audit documentation and ensure timely reporting of findings.

Qualifications

• Bachelor’s degree in life sciences, nursing, or related field (advanced degree preferred).
• Minimum 5+ years of QA auditing experience in clinical research.
• Demonstrated experience with FDA inspections and audit processes.
• Strong knowledge of ICH-GCP, FDA regulations (21 CFR Parts 11, 50, 54, 56, 312), and industry standards.
• Experience auditing clinical sites, CROs, and vendors.
• Excellent analytical, documentation, and communication skills.
• Ability to work independently and manage multiple priorities in a contract environment.

Preferred Qualifications

• Lead auditor certification or equivalent QA certification.
• Experience supporting inspection readiness for regulatory authorities.
• Background in biotech, pharma, or CRO environments.