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
Robust 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-*****-Ljbffr

📌 Gcp Auditor (Townsville)
🏢 RED Global
📍 Townsville