Posted 15 days ago
Description
We are seeking an experienced GCP Auditor based in Australia to support clinical trials and ensure compliance with ICH-GCP guidelines, regulatory requirements, and sponsor SOPs.
In this role, you will conduct risk-based audits across the clinical trial lifecycle, helping ensure clinical studies remain compliant, high quality, and inspection-ready.
Key Responsibilities
- Plan and conduct GCP audits including investigator sites, vendors, and clinical processes
- Review Trial Master Files (TMF) and key study documentation
- Evaluate informed consent, safety reporting, data integrity, and protocol compliance
- Identify findings, perform root cause analysis, and support CAPA development
- Prepare audit reports and present findings to stakeholders
- Support inspection readiness activities and mock inspections
Requirements
- Proven experience conducting GCP audits in clinical research
- Strong knowledge of ICH-GCP and global regulatory requirements
- Based in Australia
- Strong communication skills and ability to clearly present audit findings
If you’re an experienced GCP Auditor based in Australia looking for a remote opportunity, we’d love to hear from you. Please send your updated CV to
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