GCP Auditor

RED Global; Australia; A distancia; AUD 80.000 - 120.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

GCP auditing

Regulatory compliance

Root cause analysis

Communication skills

Descripción del empleo

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 [e-mail]