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 opportunity, we’d love to hear from you. Please send your updated CV to
#J-18808-Ljbffr
GCP Auditor in Sydney employer: RED Global
As a leading clinical compliance firm, we pride ourselves on fostering a supportive and collaborative work culture that values integrity and excellence. Our remote GCP Auditor role offers not only competitive benefits but also ample opportunities for professional growth and development within the dynamic field of clinical research. Join us in making a meaningful impact on clinical trials while enjoying the flexibility of working from anywhere in Australia.
