Nottingham University Hospitals (NUH) NHS Trust has identified excellence in research for the benefit of patients as a core component of its corporate vision to be the best acute teaching organisation. NUH sponsors and hosts a comprehensive portfolio of Clinical Trials of Investigational Medicinal Products (CTIMPs) and aims to maintain robust pharmacovigilance and quality management systems to ensure patient safety and data quality during the conduct of clinical trials.
Overview
The post holder, based at QMC, will assist in maintaining systems to assure the quality of clinical research undertaken within NUH in accordance with 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 role supports a culture of high quality research, promotes compliance across partners, and helps prepare for external audits and MHRA inspections.
Responsibilities
* Contribute to policy development for NUH.
* Ensure GCP and R&I SOP training is complete and records are up to date.
* Maintain accurate quality management records ready for inspection.
* Undertake quality control checks of research activity within NUH and partner organisations.
* Support systems that document accountability and traceability of investigational medicinal products (IMPs)/study drugs.
* Recognise and respond to research governance and quality issues identified during quality control checks.
* Act on departures from legislative and research governance requirements, escalating breaches as required.
* Promote a quality culture among NUH and partner researchers.
* Liaise with medical and non‑medical staff regarding research quality management issues.
* Record and report incidents to the R&I board and wider research teams, ensuring appropriate notifications to regulatory authorities.
* Communicate non‑compliances across NUH and utilise Trust reporting systems such as DATIX.
* Meet with the Research and Innovation Head to review workload and quality management activities.
* Organise and chair regular quality management operational meetings (e.g., monitoring visits, training performance).
* Assist with information governance or potential fraud and misconduct issues identified through quality control activities or inspections.
* Maintain knowledge of legislation and guidance governing clinical research through conferences, training courses, and professional networks.
* Conduct activities across documentation management, CAPA management, training management, vendor management, inspections, and monitoring as outlined below.
Education & Training
* Maintain a high level of knowledge relating to EU and UK legislation and act as an internal NUH expert.
* Maintain personal training records.
Documentation Management
* Overall management of R&I GCP documentation (policies, SOPs, forms).
* Prepare, review, and approve policies, SOPs, and forms ensuring regulatory and Trust requirements are met.
* Manage documentation control and biennial review process for SOPs.
* Ensure SOPs and forms are published in the correct format and location.
CAPA Management
* Identify and report incidents requiring corrective and preventative actions to the Quality Assurance Manager.
Training Management
* Collaborate with the R&I Workforce Development Team to maintain a training matrix for all R&I staff.
* Track compliance with the training matrix and oversee training on policies, SOPs, and documentation.
* Provide metrics on training completeness and support retention of staff training records in accordance with Trust policy.
Vendor Management
* Overall management of the R&I Approved Vendor system.
* Risk assess vendors following due diligence documentation and activities.
* Approve or reject vendors upon completion of due diligence.
* Review vendors in accordance with standard operating procedures.
Inspections
* Prepare for local inspections in collaboration with the HRGQI and senior management.
* Provide support during the conduct of inspections.
* Assist in responding to inspection findings and coordinating corrective actions.
Monitoring
* Develop, maintain and deliver a risk‑based monitoring programme for research and pharmacovigilance functions.
* Review risk assessments and monitoring plans to ensure a proportionate approach.
* Define acceptable error rates and take appropriate actions to address failures.
* Coordinate monitoring activities such as source data verification, consent processes, pharmacovigilance activities, and accountability of investigational products.
* Ensure annual review of the monitoring programme and relay findings to appropriate teams.
* Document all monitoring findings and disseminate within NUH to drive continuous improvement.
* Escalate overdue monitoring visits to the relevant teams.
* Prepare complex reports for QC oversight committees documenting monitoring activities and resolutions.
Additional Information
This role welcomes applications from people who identify as Black, Asian and Minority Ethnic, or Disabled, as NUH is striving to improve representation within the organisation.
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