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Clinical Research Chart QA/Auditor
Advanced Rheumatology of Houston
📍
The Woodlands, United States
Location
The Woodlands
Posted
June 11, 2026
Commute
Local Area
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Job Description
We are seeking an experienced Clinical Research Quality Assurance (QA) Auditor with strong FDA audit experience to support ongoing and upcoming clinical research activities. This contract role will focus on ensuring compliance with FDA regulations, GCP guidelines, and internal SOPs across clinical trials and associated processes.
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.