Quality Control Manager | University Hospitals NHS Trust

Overview

Nottingham University Hospitals (NUH) NHS Trust has identified excellence in research for the benefit of patients as a core component of our corporate vision to be the best acute teaching organisation. NUH sponsors and hosts a comprehensive portfolio of Clinical Trials of Investigational Medicinal Products (CTIMPs). NUH aims to develop and maintain robust pharmacovigilance and quality management systems in order to ensure patient safety and data quality during the conduct of clinical trials.

The post holder will assist in maintaining systems to assure the quality of clinical research undertaken within NUH in accordance with the prevailing legislative and best practice requirements, including the UK Policy Framework for Health and Social Care for Research, Good Clinical Practice, the Medicines for Human Use (Clinical Trials) Regulations, the Human Tissue Act and the Mental Capacity Act. The post holder, based at QMC, will be responsible for promoting and developing a culture that supports high quality research through help and support to research leaders and their teams.

The post holder will play a key role in the co-ordination of standards, working practices and policy implementation to ensure that NUH and our partners are at all times compliant with both internal policies and external regulatory frameworks. The post holder will also play a key role in preparing for external audits and MHRA inspections.

With over 19,000 staff, NUH is one of the largest employers in the city, playing a central role in supporting the health and wellbeing of the local population, and leading in research, education and innovation. We welcome applications from diverse backgrounds and strive to turn your job into a career.

We particularly welcome applications from people who identify as Black, Asian and Minority Ethnic, or Disabled, as we are striving to be better represented at NUH.

Contribute to policy development for NUH.

The post holder must ensure GCP and R&I SOP training is complete and their training records are up to date.

Maintain precise and accurate quality management records that are ready for inspection by regulatory bodies and Sponsors on demand.

Undertake quality control checks of research activity undertaken within and on behalf of NUH, in conduction with our partners, including but not limited to our suppliers, BRC Partners, the CRF and Clinical Trials Unit.

Through monitoring, support the management of systems to document accountability and traceability of Investigational Medicinal Products (IMPs)/study drugs in order to make certain that their receipt, storage, dispensing, administration and disposal is undertaken in accordance with local SOPs.

Recognise and respond to research governance and quality issues that might arise during quality control checks.

Recognise and act upon departures from legislative and research governance requirements including failure to follow protocols and/or SOPs, responding appropriately and escalating as required, for example, reporting serious breaches in accordance with the Medicines for Human Use (Clinical Trials) Regulations.

Promote a quality culture among NUH and our partners researchers.

Liaise with members of medical and non-medical staff regarding research quality management issues where appropriate. Maintain good working relationships with academic and service departments in order to promote effective teamwork.

Recording and reporting incidents to the R&I board and the wider research teams when appropriate, ensuring that staff involved with incidents provide all necessary reports, submissions and notifications to the attention of R&I and regulatory authorities.

Work autonomously and efficiently.

Maintain effective communication across NUH where non-compliances have been identified through monitoring, or inspection.

Ensure that any Trust reporting systems, including DATIX, are utilised appropriately.

Meet with the Research and Innovation Head of Research Governance, Quality and Integrity (HRGQI) on a regular basis to provide feedback on workload and quality management activities.

Organise and chair regular quality management operational meetings e.g.…