Quality Assurance Manager

This is a full time (part time will be considered at a minimum of 80% FTE), fixed term position for 2 years. This post is available as a secondment opportunity.

The Botnar Institute for Musculoskeletal Sciences enables and encourages research and education into the causes of musculoskeletal disease and their treatment. The Centre provides world-class facilities for scientists in the field of musculoskeletal research.

Oxford EMCRF is part of the National Institute of Health Research (NIHR) Oxford Clinical Research Facility. This is a collaboration between Oxford University and Oxford University Hospitals NHS Foundation Trust to support the delivery of experimental research in Oxford.

Oxford EMCRF supports the delivery of clinical research projects to the highest standards of research and clinical governance, ensuring that quality and safety considerations are embedded throughout the facility, and promoting a culture of continual quality improvement. The facility has a documented and maintained quality management system in accordance with the requirements of ICH GCP Guidelines and all applicable regulatory requirements.  Oxford EMCRF also aims to work to the best practice principles outlined by the NIHR UKCRF Network workstream and current MHRA Guidance for CRF accreditation.

About the Role

We are seeking an experienced and enthusiastic Quality Assurance Manager to support the EMCRF (CRF) Operational team with the implementation, maintenance and development of the CRF Quality Management System to assure that clinical research is completed in accordance with prevailing legislative and best practice requirements. In this role you will review study documents in development to ensure that they comply with current clinical trial regulations; and institutional SOPs as well as assist with the review CRF processes to ensure compliance with SOPs and regulations. You will coordinate risk assessments in the CRF space and manage the CRF Risk Register as well as review clinical trials in terms of risk, lead the construction of risk assessment and monitoring plans at trial set up and throughout the trial when necessary. Additionally, you will plan and participate in proactive audits of both systems and trials, including preparation of audit plans, audit report, and track from plan to close.

About You

You will hold a Bachelor’s degree (or the equivalent relevant education and experience), together with previous Quality Assurance experience including: conducting, managing, auditing or monitoring in a GCP environment. You will posses sound knowledge of the EU Directive 2001/20/EC, the Department of Health Research Governance Framework for Health and Social Care 2017, the Medicines for Human Use (Clinical Trials) Regulations 2004 and its amendments, Guidelines for Good Clinical Practice (GCP), the Human Tissue Act 2004, Data Protection Act 2000, GDPR 2018 and the Mental Capacity Act 2005 and the ability to interpret these in a non-commercial environment. You will also demonstrate a flexible and adaptive approach to work with an organised approach to dealing with large numbers of complex documents and an ability to think on one’s feet under pressure. Experience using iPassport is desirable.

Application Process

You will be required to upload a covering letter/supporting statement, CV and the details of two referees as part of your online application. Please quote 188222 in all correspondence.

The closing date for applications is 12pm 7 September 2026.

Interviews will take place during week commencing 14 September 2026 and will be in person.

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