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

Robust communication skills and ability to clearly present audit findings

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

📌 Gcp Auditor Sydney
🏢 RED Global
📍 Sydney