We're recruiting for a globally respected CRO seeking a UK-based Remote GCP Auditor. This role ensures patient safety and regulatory compliance across international clinical trials through expert auditing of clinical sites, processes, and documentation.
Core Responsibilities
Conduct Risk-Based Audits:<br /> * <br /> Lead remote audits of Clinical Investigator Sites, Vendors (Labs, CROs), TMF/eTMF, and Clinical Systems across UK/EU<br /> * <br /> Apply risk-based methodologies to prioritize audit targets<br />
Ensure Regulatory Compliance:<br /> * <br /> Verify adherence to ICH-GCP, UK Clinical Trials Regulations, MHRA requirements, and GDPR<br /> * <br /> Monitor CAPA effectiveness post-audit/inspection<br />
Audit Management:<br /> * <br /> Issue detailed audit reports (critical/major/minor findings) via eQMS (e.g., Veeva)<br /> * <br /> Maintain comprehensive audit documentation<br />
Support Inspections:<br /> * <br /> Host/support MHRA, EMA, and FDA inspections as GCP subject matter expert<br />
Training & Collaboration:<br /> * <br /> Deliver GCP training to clinical teams<br /> * <br /> Advise on quality issues with Clinical Operations and Data Management<br />
Essential Requirements
Residency: Must be UK-based with right to work
Education: Bachelor's/Master's in Life Sciences or related field
Experience:
*
3+ years GCP auditing in CROs/Pharma
*
Proven experience auditing Clinical Sites and TMF
Regulatory Knowledge: ICH-GCP, UK Clinical Trials Regulations, MHRA expectations
Technical Skills: eQMS (Veeva preferred), MS Office, remote auditing tools
Language: Fluent English
Preferred Profile
GCP Auditor certification (RQAP-GCP)
Experience with risk-based monitoring (RBM)
Knowledge of ATMPs (Advanced Therapy Medicinal Products)
What We Offer
Fully remote working within UK
Competitive salary + performance bonus
Private healthcare + enhanced pension
25 days holiday + flexible hours
Global development programs
