At a Glance
- Tasks: Support initiation, monitoring, and close-out of Open Label Extension Clinical Trials.
- Company: Join Clinigen, a global leader in access to medicines.
- Benefits: Hybrid role with 2-3 days onsite in Weybridge or Burton upon Trent.
- Other info: Strong understanding of GCP E6 (R3) and regulatory frameworks is essential.
- Why this job: Make a significant impact in patient access beyond clinical trials.
- Qualifications: Life sciences degree or equivalent experience; hands-on CRA experience required.
The predicted salary is between 35000 - 45000 £ per year.
We're Hiring: Clinical Research Associate - Managed Access Programmes
Location: Weybridge or Burton upon Trent – this is a hybrid role with 2-3 days onsite.
Make an Impact in Patient Access
Are you a clinical operations professional with a passion for making a difference in patients' lives beyond clinical trials? Join Clinigen, a global leader in access to medicines, and take the lead in developing Managed Access Programmes (MAPs) that ensure patients receive critical therapies post-trial or outside of commercial availability.
As a CRA, you'll play a central role in:
- Supporting initiation, setup, monitoring, and close-out activities of Open Label Extension Clinical Trials
- Ensuring protocol adherence and data integrity across programmes
- Acting as key contact for HCPs, investigators, and sites
- Defining and documenting clinical processes to support operational excellence
- Ensuring full compliance with regulatory standards
- Effectively maintaining study documentation and adhering to GCP frameworks
What We’re Looking For:
- Life sciences degree (or equivalent experience)
- Hands on experience in CRA role / clinical operations
- Strong understanding of GCP E6 (R3) and regulatory frameworks, Clinical data collection and monitoring processes
- Effective stakeholder management: you’ll be dealing with external sites & HCPs
- Strong attention to detail, organisation skills and documentation discipline
- Knowledge of Trial Master Files and Essential Records
Clinical Research Associate in Weybridge employer: Clinigen
Clinigen is dedicated to improving patient access to critical therapies. Located in Weybridge or Burton upon Trent, the company offers a hybrid work model. Join a team focused on operational excellence and compliance in clinical research.
