At a Glance
- Tasks: Conduct GCP audits and ensure compliance across clinical sites and vendors.
- Company: Join Advarra, a leader in clinical research with a focus on inclusivity and collaboration.
- Benefits: Flexible freelance role with the opportunity to make a meaningful impact in healthcare.
- Other info: Work remotely and collaborate with diverse teams across the UK.
- Why this job: Be part of a mission-driven team that improves lives through quality clinical research.
- Qualifications: 10+ years in Clinical Quality Assurance and strong GCP auditing experience required.
The predicted salary is between 60000 - 80000 £ per year.
This role is open to candidates based in the United Kingdom.
At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each person is not only valued but empowered to thrive and make a meaningful impact.
Our people—both employees and consultants—are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient‑Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives.
Advarra is seeking Good Clinical Practice (GCP) Auditors to join our consultant network for United Kingdom‑based projects. Auditors support compliance reviews across GCP clinical sites and vendors.
Job Duties & Responsibilities:
- Conduct Good Clinical Practice (GCP) audits (planning, agenda, physical or remote audit, and report writing).
- Evaluate investigator sites, CROs, and vendor compliance or qualification.
- Prepare comprehensive audit reports detailing findings and root‑causes.
- Provide written audit reports in English.
- If required, provide corrective actions support and present findings to QA leadership and stakeholders.
- Work collaboratively with clients to ensure quality standards.
Basic Qualifications:
- Minimum 10+ years of Clinical Quality Assurance and/or Good Clinical Practice (GCP) experience.
- Minimum 5+ years of Good Clinical Practices auditing experience.
- Demonstrated experience with regulatory agency expectations (e.g., FDA, EMA) and audit readiness activities.
- Demonstrated experience in developing and implementing quality assurance plans, audit programs, and corrective action plans.
- B2 level in English communication, verbal and written.
- Bachelor's degree.
Preferred Qualifications:
- Strong interpersonal and client interaction skills.
- Excellent analytical, problem‑solving, communication, and report‑writing skills.
- Ability to work collaboratively across departments and interact with internal and external stakeholders.
Pharmaceutical Quality GCP Auditors Freelance/Independent (Consulting) employer: Advarra, Inc.
At Advarra, we pride ourselves on being an exceptional employer that values inclusivity and collaboration, making it an ideal place for Pharmaceutical Quality GCP Auditors to thrive. Our commitment to a patient-centric culture ensures that every team member is empowered to make a meaningful impact in clinical research, while our focus on professional growth and development provides ample opportunities for career advancement. Located in the United Kingdom, our supportive work environment fosters respect and diverse perspectives, allowing you to contribute to a mission that truly matters.
