GCP QA Consultant
Job Summary
To support clinical programs in oncology research, the remote GCP QA Consultant will ensure compliance with Good Clinical Practice (GCP) standards, drive quality improvements, and prepare for regulatory inspections on a contract basis.
Key responsibilities:
- Review key clinical trial documentation, including protocols and informed consent forms
- Lead assessments and investigations of quality issues, including root cause analysis and remediation
- Coordinate GCP-GVP vendor audits and oversee quality management with functional lines and vendors
Required qualifications:
- Bachelor's degree in a scientific field; advanced degree in clinical research is a plus
- Strong knowledge of GCP and clinical research practices in the US and EU
- Experience in oncology clinical trials is preferred
- Certification as a Registered Quality Assurance Professional (RQAP) in GCP is expected
- Familiarity with regulatory inspection processes and risk-based quality management
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