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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Strong 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 chance, we'd love to hear from you. Please send your updated CV to
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#J-*****-Ljbffr

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