About this role
Job summary
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.
Main duties of the job
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.
About us
With over 19,000 staff, we are one of the biggest employers in the city with a central role in supporting the health and wellbeing of our local population. We play a leading role in research, education and innovation.
Come and join our wonderful team at NUH. We are big believers in diversity and welcome new ideas to help develop our team in order to deliver world class healthcare to the vast patient populations we serve. With endless personal development opportunities available, at NUH we will endeavour 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.
Job description Job responsibilities
GENERAL DUTIES
General
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. Monitoring visits, Training performance.
Work in accordance with Trustwide policies and procedures.
Assist in any information governance or potential fraud and misconduct issues identified through quality control activities or inspection.
Maintain knowledge of legislation and guidance governing clinical research and quality management processes, for example, through attending conferences, training courses, or through relevant networks or forums.
Education and Training
Maintain a high level of knowledge relating to the EU and UK legislation, regulations, management and conduct of research and act as an NUH expert on these matters.
Maintain personal training record.
Documentation Management
Overall Management of the R&I GCP documentation e.g. policies, SOPs and forms.
Manage the preparation, review and approval of policies, standard operating procedures and forms, ensuring that all regulatory and Trust requirements are encapsulated.
Manage the documentation control of SOPs and forms.
Manage the 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 ensure an appropriate training matrix for all R&I staff.
Overall management and tracking of the R&I workforce compliance with the training matrix.
Oversight of training on policies, SOPs, templates and other appropriate documentation for R&I staff and researchers, ensuring this is appropriately documented.
Provide metrics on training completeness to the HRGQI for quarterly reporting.
Manage the process for retention of staff training records in accordance with Trust Policy.
Provide support and advice to NUH researchers regarding the principles of ICH-GCP and compliance.
Assist the HRGQI, QA Manager, Research Governance Manager and Workforce Development Team in preparing and delivering targeted training programmes of the principles of ICH-GCP, research governance, compliance and quality management to departments involved in research and pharmacovigilance activities, and other members of the Research and Innovation department.
Vendor Management
Overall Management of the R&I Approved Vendor system.
Risk assess vendors following review of associated due diligence documentation, including the vendor questionnaire, and activities.
Approve or reject vendors on completion of due diligence documentation and activities.
Review vendors in accordance with associated standard operating procedures.
Inspections
In collaboration with the HRGQI and senior management team, conduct the appropriate preparation for local inspections.
Provide support during the conduct of local inspections.
Assist in providing responses to inspection findings and coordinating corrective and preventative actions.
Monitoring
Develop, maintain and deliver a risk-based monitoring programme for the research and pharmacovigilance functions within NUH to determine on-going compliance to the research protocols, principles of ICH-GCP, regulatory requirements, and NUH SOPs and policies.
Review risk assessments and monitoring plans to ensure a risk proportionate approach to monitoring.
Review and define acceptable error rates, and take appropriate actions to address any failure to meet required standards.
Interact with research teams and departments to arrange monitoring activities, to include (but not limited to):
Source data verification
Consent processes
Pharmacovigilance activities
Accountability (investigational medicinal products, devices and equipment, and clinical samples)
Ensure the monitoring programme is annually reviewed and is risk based.
Liaise with research teams to ensure monitoring reports are complete, overseeing completion of any actions.
Ensure all monitoring findings are relayed to the appropriate teams, such as the Quality Assurance Manager and HRGQI so that any corrective and preventive actions can be put in place where necessary, which may include triggering audits for the QA team.
Ensure that these monitoring activities are documented and that findings are disseminated within NUH in order to drive continuous improvement to procedures.
Ensure all overdue monitoring visits are escalated to research team, HRGQI and senior R&I management (where required).
Assist in the preparation of complex reports for the relevant QC oversight committees, documenting monitoring activities, metrics, findings and resolutions.
This list of responsibilities is not exhaustive, the post holder will be expected to undertake any other relevant duties appropriate to the grading of the post.
Person Specification
Commitment to Trust Values and Behaviours Essential
Must be able to demonstrate behaviours consistent with the Trust's "We are here for you" behavioural standards
Training & Qualifications Essential
Educated to at least Master's degree level / or equivalent experience in a related subject area, e.g. a life science or clinical subject. Expert knowledge of: i.Good Clinical Practice as defined in the Medicines for Human Use (Clinical Trials) Regulations; ii.the Human Tissue Act and iii.the Mental Capacity Act. iv.Data Protection Act (2018) and UK GDPR Knowledge of the clinical trial lifecycle from confirmation of sponsorship through to archiving. Evidence of Continuous Personal Development
Desirable
Quality improvement Qualification i.e. QSIR Project Management Qualification i.e. PRINCE2 Understanding of other GCP principles (GxP) Understanding of clinical investigations of medical devices (ISO14155). Monitoring of Non-Commercial Clinical Research Studies Qualification.
Experience Essential
Experience of the design and management of quality control activities within a clinical research environment. Experience within either a pharmaceutical company, contract research organisation, NHS or academic setting of : i.risk assessments (including defining and reviewing acceptable error rates); ii.monitoring visits; iii.source data verification Experience of developing, implementing and following standard operating procedures in a clinical research environment. Experience of developing and delivering research-related training modules to a variety of audiences both online and in person. Experience of implementing a risk proportional approach to quality control activities. Proficient IT skills, particularly in the use of Web applications and MS Office applications. Line management experience. Experience presenting complex reports to senior committees or Board-level groups
Desirable
Understanding of the NHS and its research priorities. Experience of working within the UK Policy Framework for Health and Social Care Research (2017). Experience of quality systems management within clinical research. Experience of computer systems validation. Knowledge of current national systems and structures for the approval, management and monitoring of clinical research in the NHS. Experience of research across a range of therapeutic areas. Experience of project management and leading quality improvement initiatives. Experience of preparing for and supporting regulatory inspections.
Communication and Relationship Skills Essential
Ability to influence, negotiate, and support change across teams to embed a just culture and continuous improvement approach. Excellent interpersonal and communication skills, with ability to engage effectively with multidisciplinary teams and stakeholders Ability to communicate difficult and sometimes challenging information both orally and in writing, internally and externally to a range of audiences. Ability to build excellent working relationships and gain the respect and confidence of others.
Desirable
Ability to deliver feedback in a positive and encouraging manner. Ability to deal with challenging behaviour from researchers in a calm, diplomatic and professional manner. Highly motivated to improve the understanding of Quality amongst researchers.
Analytical and Judgement Skills Essential
Strong analytical skills with the ability to interpret complex data, identify themes, and support systems-based learning and improvement Experience of producing high-quality written reports Ability to make judgements regarding a range of highly complex research management issues. Strong problem solving and negotiation skills.
Desirable
Ability to construct a balanced argument to internal and external parties.
Planning and Organisation Skills Essential
Ability to plan, manage and deliver complex projects, involving multiple agencies and individuals and a range of tasks. Demonstrates attention to detail alongside the ability to extract key learning from complex information. Ability to work autonomously, prioritise workload, and translate strategic priorities into operational plans, consistently to tight timelines
Desirable
Flexible approach to working.
Physical Skills Essential
Physical effort: Frequent requirement to work in a restricted position, when using a computer. Mental effort: Frequent requirement for concentration, with an unpredictable work pattern Emotional effort: Occasional exposure to distressing or emotional circumstances, or challenging behaviour. Working conditions: Use of computer continuously for prolonged periods on most days.
Other requirements specific to the role (e.g. be able to drive or work shifts) Essential
Ability to travel across both campuses, regionally and nationally to conduct monitoring visits and attend meetings, training and conferences.
Disclosure and Barring Service Check This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Employer details Employer name Nottingham University Hospitals NHS Trusts
Address Queens Medical Centre, Nottingham University Hospitals NHS Trust
Nottingham
NG7 2UH
United Kingdom
Employer's website https://www.nuh.nhs.uk/ (Opens in a new tab)