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- 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 opportunities to make a meaningful impact in healthcare.
- Other info: Work remotely and collaborate with diverse teams to advance clinical research.
- Why this job: Be part of a mission-driven team that values your expertise and empowers you to thrive.
- 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, will 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) in London employer: Advarra
Contact Detail:
Advarra Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Pharmaceutical Quality GCP Auditors Freelance/Independent (Consulting) in London
✨Network Like a Pro
Get out there and connect with people in the industry! Attend events, join online forums, and engage on social media. The more you network, the better your chances of landing that freelance gig with Advarra.
✨Show Off Your Skills
When you get the chance to chat with potential clients or during interviews, make sure to highlight your GCP auditing experience. Share specific examples of how you've tackled challenges in past roles to demonstrate your expertise.
✨Be Proactive
Don’t just wait for job postings to pop up! Reach out directly to companies like Advarra and express your interest in joining their consultant network. A little initiative can go a long way in getting noticed.
✨Keep Learning
Stay updated on the latest trends and regulations in clinical quality assurance. Consider taking additional courses or certifications to boost your profile. This shows you're committed and ready to make an impact!
We think you need these skills to ace Pharmaceutical Quality GCP Auditors Freelance/Independent (Consulting) in London
Some tips for your application 🫡
Get to Know Us: Before you start your application, take a moment to familiarise yourself with Advarra's values and culture. We’re all about being patient-centric, ethical, and collaborative, so make sure your application reflects these principles.
Tailor Your Application: Don’t just send in a generic CV and cover letter! We want to see how your experience aligns with the GCP auditing role. Highlight your relevant skills and experiences that match the job description to stand out.
Be Clear and Concise: When writing your application, keep it clear and to the point. Use straightforward language and avoid jargon unless it's relevant to the role. We appreciate well-structured reports, so show us your best writing skills!
Apply Through Our Website: If you're not already part of our network, make sure to register using the Expert Enrollment Form on our website. This is the first step to being considered for the role, so don’t skip it!
How to prepare for a job interview at Advarra
✨Know Your GCP Inside Out
Make sure you brush up on your Good Clinical Practice knowledge before the interview. Familiarise yourself with the latest regulations and guidelines, especially those from the FDA and EMA. Being able to discuss these confidently will show that you're not just experienced but also up-to-date.
✨Prepare for Scenario Questions
Expect to be asked about specific situations you've encountered in your auditing experience. Prepare examples that highlight your problem-solving skills and how you've handled compliance issues. Use the STAR method (Situation, Task, Action, Result) to structure your answers clearly.
✨Showcase Your Collaborative Spirit
Advarra values collaboration, so be ready to discuss how you've worked with clients and stakeholders in the past. Share examples of how you’ve built relationships and ensured quality standards through teamwork. This will demonstrate that you align with their company culture.
✨Practice Your Report Writing Skills
Since you'll need to provide comprehensive audit reports, it’s crucial to showcase your report writing skills during the interview. Bring along samples of your previous work if possible, and be prepared to discuss your approach to writing clear and concise reports.