Quality Assurance Officer

Applications are invited for the above position within the North Wales Organisation for Randomised Trials in Health and Social Care (NWORTH).

This is an exciting opportunity to join a highly motivated Clinical Trials Unit team and play a leading role in maintaining the Unit’s reputation for excellence in conducting research of the highest quality. As lead for the quality assurance (QA) function at the Clinical Trials Unit, the post holder will be responsible for the Unit’s quality management system and will ensure that the Unit maintains robust systems and processes to ensure compliance with national and international standards for the conduct of health and social care research.

The post-holder will be responsible for instigating regular audits and lead on NWORTH’s preparations for regulatory inspections by the Medical Healthcare products Regulatory Agency (MHRA) and will link with the UK Clinical Research Collaboration (UKCRC) QA Subgroup.

Applications will also be considered to carry out this role on a part-time or job share basis.

The ability to communicate in Welsh is desirable for this post.

Committed to Equal Opportunities

Overview

Bangor University:
A reputation for excellence. Founded in 1884, Bangor University has a long tradition of academic excellence and a strong focus on the student experience. Bangor University’s research has been ranked highly in the Government’s most recent Research Excellence Framework (REF2021), with 85% judged to be world-leading (4*) or internationally excellent (3*).The University is located in an area of outstanding natural beauty, between the mountains of Snowdonia and the shores of the Menai Strait - and road and rail links to Liverpool, Manchester, London and elsewhere are excellent.

College of Medicine and Health:
The College of Medicine and Health is one of three colleges at Bangor University. The College, through the University, is formally linked to the Betsi Cadwaladr University Health Board enabling an integrated approach to developing research, training, medical and healthcare education that serves the needs of North Wales and beyond.

North Wales Medical School:
The North Wales Medical School aims to champion and promote excellent medical and health sciences, research, scholarship, teaching and learning, quality and values with people who use services, practitioners, and stakeholders. Its mission is to promote language and cultural competence relevant to local, national and international partners, and provide an inclusive culture and environment for staff and students within the school.

North Wales Organisation for Randomised Trials in Health and Social Care (NWORTH):
NWORTH is a clinical trials unit (CTU) which has full UKCRC registration. The mission of the Unit is to conduct clinical trials and studies of complex interventions of the highest quality, delivering research with impact and advancing methodological developments in clinical trials research. With a history of successful design and delivery of pragmatic trials of complex interventions, NWORTH provides a wide range of research and development opportunities for its staff.

Purpose of the Job

The post is to provide 9-months maternity cover for the current Quality Assurance Officer. As part of an established team working in the area of clinical trials, the postholder will ensure NWORTH Clinical Trials Unit is compliant with national and international standards for the conduct of health research including:
UK policy framework for health and social care research (2017), the World Medical Association Declaration of Helsinki (1996), Principles of ICH Good Clinical Practice, and the current regulatory requirements, as detailed in the Medicines for Human Use (Clinical Trials) Regulations 2004 (UK S.I. 2004/1031) and subsequent amendments of the clinical trial regulations. The post holder will provide the QA insight into prospective new collaborations and feed these back to the core operational team at project triage.

Main

**Responsibilities**:

- To provide specialist advice to NWORTH staff, collaborators and participating centres on national and international standards for the conduct of clinical research and to ensure that NWORTH is compliant.- To maintain and develop the existing Quality Management System (QMS), to monitor compliance to UK regulations within NWORTH projects and update as and when necessary.- To liaise with University’s Governance Services to support alignment of NWORTH QMS with the University’s Research Governance policies.To be responsible for:

- Quality Assurance activities related to the clinical trial(s) managed by NWORTH and to ensure that relevant staff are fully aware of, trained in, and comply with trial regulations.- To provide training as and when necessary, on Standard Operating Procedures (SOPs), quality and regulatory-related activities.- To plan, develop and monitor the implementation of SOPs within NWORTH and, where appropriate, within individua