Remote GCP Auditor – Australia Compliance & Audit

RED Global; Australia; Remote; AUD 80,000 - 120,000; Full time

Job summary

A leading clinical compliance firm is seeking an experienced GCP Auditor based in Australia to support clinical trials. This role involves planning and conducting GCP audits, reviewing trial documentation, and ensuring compliance with ICH-GCP guidelines. The ideal candidate should have a proven track record in clinical research audits and strong communication skills. This is a remote opportunity. Interested candidates should send their updated CV to an email provided.

Qualifications

• Proven experience conducting GCP audits in clinical research.
• Strong knowledge of ICH-GCP and global regulatory requirements.
• Strong communication skills and ability to clearly present audit findings.

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.

Skills

GCP auditing

Regulatory compliance

Root cause analysis

Communication skills

Job description

A leading clinical compliance firm is seeking an experienced GCP Auditor based in Australia to support clinical trials. This role involves planning and conducting GCP audits, reviewing trial documentation, and ensuring compliance with ICH-GCP guidelines. The ideal candidate should have a proven track record in clinical research audits and strong communication skills. This is a remote opportunity. Interested candidates should send their updated CV to an email provided.