Job 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 chance, we'd love to hear from you.
Please send your updated CV ******
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📌 Gcp Auditor (New South Wales)
🏢 RED Global
📍 New South Wales