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Quality Assurance and Research Manager
| Posting date: | 25 February 2025 |
|---|---|
| Salary: | £61,927.00 to £68,676.00 per year |
| Additional salary information: | £61927.00 - £68676.00 a year |
| Hours: | Full time |
| Closing date: | 16 March 2025 |
| Location: | London, SW3 6NP |
| Company: | NHS Jobs |
| Job type: | Permanent |
| Job reference: | C9196-25-0330 |
Summary
Communication Represent the Research Office internally and externally to develop effective communication and collaborative working in the wider NHS and with counterparts at Imperial College London, Kings College London, Brunel University and other collaborative partners in order to maintain regulatory compliance for research. Present complex information on all aspects of the service in a clear, understandable and audience-appropriate manner to senior management, internal and external stakeholders. To be the lead contact within the Research Office providing advice, training and support to investigators on compliance with the UK Policy for Health and Social Care Research and any other legislation applicable to research projects. Policy & Service development Maintain a Quality Management System (QMS) and document control process for all critical documents within the Research Office and ensure that these documents are communicated, implemented, monitored, reviewed and kept up to date to ensure compliance with the complex requirements of the UK Policy Framework for Health and Social Care Research, ICH Good Clinical Practice (GCP), EU Clinical Trials Directive and specifically Medicines for Human Use Clinical Trials Regulation 2004 (as amended) and medical device regulations (as appropriate). Challenge ways of working and persuade, motivate and influence other senior managers to realign their practice where necessary in particular within the Research Office teams Research Delivery Teams, researchers and their research teams and other stakeholders as appropriate to implement necessary changes to processes to ensure compliance with Trust policies for research. Engage with stakeholders (multidisciplinary and cross-divisional) to understand the full scope of detailed patient pathways, to ensure that any new processes are fit for purpose and that staff are actively engaged and supportive of overall audit activities of clinical research. To be responsible for the Research Offices oversight and monitoring processes to ensure compliance with research regulations and Trust policies associated with the UK Policy Framework for Health and Social Care Research and other relevant regulations. To work closely with the Chair of the relevant Oversight Committee to ensure that the Research Office complies with all regulatory requirements in the context of the UK Policy Framework for Health and Social Care Research, The Medicines for Human Use (Clinical Trials) Regulations and the UK legislation implementing Good Clinical Practice (GCP) for CTIMPs, as applicable. To take the lead in the organisation of the relevant Oversight meetings, including minute taking, ensuring that appropriate issues are considered, managed and any decisions/actions implemented. Project Design, Set-up and OversightTo lead a team and take part in supporting investigators and their research teams in planning new clinical research projects, ensuring that all aspects of the regulations have been considered; providing advice on development of protocol and associated documents. The role will also involve line management responsibilities of grant funded clinical trial managers/officers employed for specific Trust sponsored research projects. Review and put agreements in place, in close collaboration with the legal advisor/contracts team, to direct and define responsibilities between the Trust and third parties to support sponsored research projects. To act as the authority on regulatory and feasibility advice on grant submissions. To critically evaluate and suggest ways forward that will, if grant is awarded, lead to successful completion of project. To lead on ensuring that appropriate set-up activities are in place (including costings and contracts/agreements) prior to commencing patient recruitment for all research set up by the Research Office. To establish and agree appropriate monitoring and audit plans for all sponsored research projects overseen by the Research Office, maintaining appropriate evidence of monitoring, audit and inspection including associated reporting (via Clin-ROC Royal Brompton and Harefield Hospitals Clinical Research Oversight Committee) and action plans arising from this activity to proactively identify corrective and preventative measures to improve service. Work closely with research delivery teams to answer safety/regulatory related queries promptly and efficiently in relation to requirements of legislation impacting on the conduct of clinical trials, acknowledging all communication, and ensuring efficient flow of information. To ensure that study closure and archiving procedures are compliant with research regulations. To oversee the Research Office budget in relation to sponsored research projects, including sign off of related invoices and purchase order requisitions, working closely with the Associate Director of Research and Research Business Manager. Quality Management Maintain a Quality Management System (QMS) and document control process for all critical documents within the service and ensure that these documents are communicated, implemented, monitored and reviewed considering new changing requirements, legislations and standards. Monitor and analyse the performance of the service and relevant parties (e.g. research teams) by establishing and conducting a robust auditing process. Instigate the collection of complex or sensitive data, collate and analyse the results. Oversee and advise on the suitable resolution of audit findings, incidents and complaints through the implementation of root cause analysis and corrective and preventative actions (CAPAs). Establish regular reporting and trending to identify areas for improvement of persistent errors. Communicate audit findings to audit stakeholders ensuring understanding and collaboration with auditees to develop CAPAs to address root cause analysis and produce detailed written reports To be the lead point of contact for the Quality and Safety Department in relation to investigating any incidents that are related to research and reported to the Trust patient safety database (RADAR). To coordinate and act as the key contact with support services for statutory MHRA inspections (e.g. staff meetings to ensure training and inform of outcomes) in conjunction with the Associate Director, the Research Office, service departments and investigators. Ensure the suitability and provide support to local sites and pharmacy departments conducting hosted CTIMPs before, during and after regulatory inspections. To respond to findings of MHRA inspections, while identifying risk areas, taking forward corrective and preventative actions (CAPAs) and escalating CAPAs to the Clin- ROC and Trust R&D centrally as appropriate. People management To provide professional leadership by providing line management to the QA and Sponsorship team (clinical trial managers, monitor), ensuring continued professional development through appraisal, identification of skill gaps and by facilitating access to appropriate training opportunities to improve performance where deficits are identified. To lead the selection and recruitment of staff in compliance team, contributing to recruitment to other roles across the Research Office and delivery teams as appropriate. To ensure the delivery of Trust research governance and clinical trials policies within the Research Office and externally through a matrix management structure providing proactive advice and support as required. Further sections To ensure all team members have a real voice in the development of the Research Regulatory Compliance, Quality Assurance and Quality Control service to patients/customers in relation to regulatory compliance with any applicable research legislations To maximise the potential of all team members and to ensure that all team members have a meaningful appraisal/personal development plan that includes feedback to the individual from a selection of internal customers and team members To provide a safe and attractive working environment for team members within available resources To attend and play a part in corporate groups as a representative of the directorate and team to represent the Trust at regional and national conferences and on working groups as appropriate To abide by the NHS Code of conduct for managers, the Trusts Core behaviours for staff and managers and all other Trust policies, codes and practices, including standing financial instructions, research governance, clinical governance, patient and public involvement and health and safety. To undertake any other duties commensurate with the grade as requested.