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
1.
Conduct Risk-Based Audits:
*
Lead remote audits of Clinical Investigator Sites, Vendors (Labs, CROs), TMF/eTMF, and Clinical Systems across UK/EU
*
Apply risk-based methodologies to prioritize audit targets
2.
Ensure Regulatory Compliance:
*
Verify adherence to ICH-GCP, UK Clinical Trials Regulations, MHRA requirements, and GDPR
*
Monitor CAPA effectiveness post-audit/inspection
3.
Audit Management:
*
Issue detailed audit reports (critical/major/minor findings) via eQMS (e.g., Veeva)
*
Maintain comprehensive audit documentation
4.
Support Inspections:
*
Host/support MHRA, EMA, and FDA inspections as GCP subject matter expert
5.
Training & Collaboration:
*
Deliver GCP training to clinical teams
*
Advise on quality issues with Clinical Operations and Data Management
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