GCP Auditor

GCP Auditor – Australia Based

📍 Remote (Australia) | Contract or Permanent

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 inspectionsRequirements

• 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 mgordon@redglobal.com