We are seeking an experiencedGCP Auditor based in Australiato support clinical trials and ensure compliance withICH-GCP guidelines, regulatory requirements, and sponsor SOPs.
In this role, you will conductrisk-based audits across the clinical trial lifecycle, helping ensure clinical studies remain compliant, high quality, and inspection-ready.
Key Responsibilities
Plan and conductGCP auditsincluding investigator sites, vendors, and clinical processes
ReviewTrial Master Files (TMF)and key study documentation
Evaluateinformed consent, safety reporting, data integrity, and protocol compliance
Identify findings, performroot cause analysis, and supportCAPA development
Prepare audit reports and present findings to stakeholders
Supportinspection readiness activitiesandmock inspections
Requirements
Proven experience conductingGCP audits in clinical research
Solid knowledge ofICH-GCP and global regulatory requirements
Based in Australia
Solid communication skills and ability to clearly present audit findings
If you're an experiencedGCP Auditor based in Australialooking for a remote prospect, we'd love to hear from you.
Please send your updated CV to
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📌 Gcp Auditor Melbourne
🏢 RED Global
📍 Melbourne