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gcp audit capa fda tmf📋 Description
- Provide independent GCP quality oversight for ongoing Phase IIb/III trials.
- Review study documentation for compliance with ICH-GCP and 21 CFR.
- Conduct remote GCP audits of CROs and vendors; TMF quality reviews.
- Partner with Clinical Operations to address quality risks and indicators.
- Support FDA inspection readiness activities and CAPA reviews.
- Prepare audit reports and executive quality trend summaries.
🎯 Requirements
- Bachelor's degree in Life Sciences or related field.
- Minimum 5+ years of Clinical QA experience.
- Phase IIb/III U.S. trials experience.
- Strong knowledge of ICH-GCP, FDA regs, and risk-based quality management.
- GCP audits (site/process/vendor) experience and FDA readiness.
- Quality certification (CQA, RAC) preferred.
🎁 Benefits
- Fully remote contract role (1099).
- Client-facing role with sponsor.
- Global CRO environment with growth opportunities.
- Competitive hourly rate.
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