GCP Auditor
We are seeking an experienced GCP Auditor based in the EU to conduct Clinical Investigator Site Audits across Europe.
Requirement is for an auditor with a strong track record of conducting GCP audits at clinical investigator sites and will be responsible for the full audit lifecycle, from preparation and execution through to reporting and issuance of the audit certificate.
The Role
- Plan and conduct GCP audits of clinical investigator sites across the EU.
- Perform audit preparation activities, including review of relevant study documentation and development of an audit plan.
- Conduct 2-day on-site GCP audits at clinical investigator sites.
- Assess site compliance with applicable:
- ICH-GCP requirements
- EU clinical trial regulations and applicable national requirements
- Study protocols and relevant procedures
- Sponsor requirements and applicable quality standards
- Identify, document and assess audit findings and observations.
- Conduct appropriate discussions with site personnel and study teams during and following the audit.
- Prepare a comprehensive audit report within 10 business days of completion of each audit.
- Issue an audit certificate following completion of each audit.
- Ensure audit documentation is complete, accurate, objective and delivered in accordance with agreed timelines.
- Communicate effectively with relevant stakeholders regarding audit findings and outcomes.
Audits will be conducted across Europe, with initial sites expected to include:
- Poland
- Netherlands
- Portugal
- Other EU locations as required
Travel to investigator sites will therefore be required.
Requirements
- Demonstrated experience conducting GCP audits at clinical investigator sites.
- Strong knowledge of ICH-GCP and European clinical trial requirements.
- Experience independently managing the full audit lifecycle, including preparation, on-site execution, reporting and follow-up documentation.
- Experience auditing investigator sites in multiple European countries is highly desirable.
- Strong understanding of clinical trial processes, including investigator responsibilities, informed consent, source documentation, essential documents and investigational medicinal product management.
- Excellent written and verbal communication skills.
- Strong attention to detail and ability to produce clear, objective and inspection-ready audit reports.
- Ability to work independently and manage multiple audits and deliverables to tight timelines.
- Based in the EU and able to travel to clinical investigator sites across Europe.
For each Clinical Investigator Site Audit, the expected deliverables will include:
- Audit preparation – including document review and audit planning.
- 2-day on-site GCP audit.
- Final audit report within 10 business days of audit execution.
- Audit certificate following completion of the audit.
This is an excellent opportunity for an experienced EU-based GCP Auditor to support a programme of investigator site audits across multiple European countries.
How to Apply
This contract opportunity is exclusive to The Source.
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