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.

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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.

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Key Responsibilities

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- Plan and conduct GCP audits including investigator sites, vendors, and clinical processes
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- Review Trial Master Files (TMF) and key study documentation
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- Evaluate informed consent, safety reporting, data integrity, and protocol compliance
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- Identify findings, perform root cause analysis, and support CAPA development
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- Prepare audit reports and present findings to stakeholders
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- Support inspection readiness activities and mock inspections
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Requirements

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- Proven experience conducting GCP audits in clinical research
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- Robust knowledge of ICH-GCP and global regulatory requirements
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- Based in Australia
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- Strong communication skills and ability to clearly present audit findings
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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 [email protected]

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📌 GCP Auditor (New South Wales)
🏢 RED Global
📍 New South Wales