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 prospect, we’d love to hear from you. Please send your updated CV to

#J-18808-Ljbffr

📌 GCP Auditor (Australia)
🏢 RED Global
📍 Australia