Quality Assurance Manager

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. What We Offer As an employer, we genuinely care about our employees' wellbeing and this is reflected in the range of benefits that we offer including:

• An excellent contributory pension scheme
• 38 days annual leave
• A comprehensive range of childcare services
• Family leave schemes
• Cycle loan scheme
• Discounted bus travel and Season Ticket travel loans
• Membership to a variety of social and sports clubs, 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.

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.

Oxford Experimental Medicine Clinical Research Facility Churchill Drive, Headington, OX3 7LA, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS) Grade 7: £39,424 per annum. This is inclusive of a pensionable Oxford University Weighting of £1,730 per year. 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 University of Oxford is a stimulating work environment, which enjoys an international reputation as a world-class centre of excellence. Our research plays a key role in tackling many global challenges, from reducing our carbon emissions to developing vaccines during a pandemic. The Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS) is part of the Medical Sciences Division and is the largest European academic department in its field, running a globally competitive programme of research and teaching. 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.