Good Clinical Practice (GCP) Auditor – Consultant Network
Company Overview
Advarra is a clinical research organization focused on advancing clinical trials through ethical, patient-centric, and high-quality research practices. The company promotes an inclusive and collaborative culture guided by values of:
Patient-Centric approach
Ethical conduct
Quality focus
Collaboration
Job Overview
Advarra is seeking Good Clinical Practice (GCP) Auditors to join its consultant network for United Kingdom-based projects. The role focuses on supporting clinical trial compliance through audits of clinical sites, CROs, and vendors.
Location
United Kingdom (UK) – Remote/Project-based opportunities
Role Purpose
GCP Auditors are responsible for ensuring compliance with Good Clinical Practice (GCP) standards by conducting audits, identifying gaps, and ensuring quality systems in clinical research operations.
The role supports inspection readiness and strengthens clinical trial quality and regulatory compliance.
Key Responsibilities
1. GCP Audits
Plan and conduct GCP audits (onsite or remote).
Prepare audit agendas and execution plans.
Evaluate clinical investigator sites, CROs, and vendors.
Assess compliance with regulatory and GCP requirements.
2. Reporting & Documentation
Prepare detailed audit reports in English.
Document findings, observations, and root-cause analysis.
Maintain clear, structured, and high-quality audit documentation.
3. Compliance & Quality Assurance
Support corrective and preventive action (CAPA) processes.
Assist in implementing quality assurance and audit programs.
Contribute to inspection readiness activities.
4. Stakeholder Engagement
Present audit findings to QA leadership and stakeholders (when required).
Collaborate with clients and cross-functional teams.
Ensure alignment on quality standards and compliance expectations.
Required Qualifications
Education
Bachelor’s degree in a relevant field
Experience
Minimum 10+ years of experience in:
Clinical Quality Assurance (QA) and/or GCP environment
Minimum 5+ years of experience in:
GCP auditing
Regulatory Knowledge
Strong understanding of regulatory requirements including:
FDA guidelines
EMA guidelines
Experience in audit readiness and compliance frameworks
Experience developing:
Audit programs
Quality assurance plans
CAPA processes
Language Skills
Minimum B2 level English proficiency (spoken and written)
Preferred Skills
Strong analytical and problem-solving ability
Excellent report writing skills
Strong communication and interpersonal skills
Ability to work with cross-functional and international stakeholders
Client-facing experience in a consulting or audit environment
Strong attention to detail and structured thinking
Key Competencies
Clinical Quality Assurance expertise
GCP compliance knowledge
Audit planning and execution
Risk identification and mitigation
Regulatory inspection readiness
Stakeholder communication
Root cause analysis
CAPA management
Application Note
Candidates already in Advarra’s expert network are not required to reapply via the external form.
Registration through the Expert Enrollment Form is mandatory for new candidates:
https://advarra.my.site.com/experts/s/
Company Values
Advarra emphasizes:
Ethical conduct
High-quality standards
Patient safety
Collaboration
Respect for diversity and inclusion
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