Quality Assurance and Research Manager
Guy’s and St Thomas’ is among the UK’s busiest and most successful NHS foundation trusts. We provide a full range of hospital and community services for people in south London and as well as specialist care for patients from further afield including cancer, renal, orthopaedic, respiratory and cardiovascular services.
Guy’s is home to the largest dental school in Europe and a £160 million Cancer Centre opened in 2016. As part of our commitment to provide care closer to home, in 2017 we also opened a cancer centre and a kidney treatment centre at Queen Mary’s Hospital in Sidcup.St Thomas’ has one of the largest critical care units in the UK and one of the busiest emergency departments in London. It is also home to Evelina London Children’s Hospital.
Evelina London cares for local children in Lambeth and Southwark and provides specialist services across south east England including cardiac, renal and critical care services. We lead a number of specialist service networks aiming to ensure children are treated locally where possible, but have access to specialist expertise when they need it.Our community services include health visiting, school nursing and support for families of children with long-term conditions.
Our adult community services teams deliver care at the heart of the local communities we serve, working in partnership with GPs, local authorities and other healthcare and voluntary sector organisations. Working with our partners in Lambeth and Southwark, we are focusing on new ways of working to improve care for local patients.
In February 2021 the Royal Brompton and Harefield joined Guy’s and St Thomas’ NHS Foundation Trust, bringing together world-leading expertise in the care and research of heart and lung disease. Our merger provides a once in a generation opportunity to build a lasting, world-renowned heart and lung centre, providing the highest quality care for patients and conducting world-leading research.
We have a reputation for clinical excellence and high quality teaching and research. We are part of King’s Health Partners, one of eight accredited UK academic health sciences centres. In partnership with King’s College London we have dedicated clinical research facilities including an MHRA accredited Phase I clinical trials unit.
Patients are at the heart of everything we do and we pride ourselves on ensuring the best possible patient experience as well as safe, high quality care. We are proud to have one of the lowest mortality rates in the NHS. Following a comprehensive Care Quality Commission (CQC) inspection in 2019 we maintained our overall rating of ‘good’.Our adult community services achieved a rating of ‘outstanding’.
The commitment of our 23,500 staff is key to our success. We are one of the largest local employers and we aim to develop and support all our staff so they are able to deliver high quality, safe and efficient care. The 2019 NHS staff survey results show that we have one of the most engaged and motivated workforces in the NHS.We know this has a positive impact on the care provided to our patients.
We have one of the most ambitious capital investment programmes anywhere in the NHS.
Job overview
We are looking for an enthusiastic and dynamic Quality Assurance and Research Manager with experience of managing a team, managing a large and varied workload, and with deep knowledge about regulatory compliance.
The postholder will manage the QA and Sponsorship team to ensure appropriate setup of sponsored projects, and oversight of research activity, including hosted projects, across the activity areas.
Main duties of the job
As the Research Office’s subject matter expert in research governance and regulatory compliance, the post holder will be responsible for ensuring that research undertaken fulfils the extensive legal requirements for setting up, conducting and managing clinical research in line with any applicable regulatory requirements.
Working for our organisation
The post holder will be in regular contact with clinical, research and academic staff within Guy’s & St Thomas’ NHS Foundation Trust, Imperial College London (ICL), King’s College London (KCL), in addition to outside organisations/agencies. This will include the following:
- Senior R&D leadership in the Clinical Group as well as the Trust
- Trust Finance team
- Central R&D Department
- King’s Health Partner’s Clinical Trials Office
- The Trust’s Clinical Research Facilities and Service Departments
- South London Research Delivery Network (RDN)
- Grants and Contracts team within the Trust
- Trust R&D Governance Leads
- Investigators from within the Trust and KCL and ICL
- Research Delivery Teams
- Quality and Safety Department
The post holder is required to follow Trust policies and procedures which are regularly updated.
Detailed job description and main responsibilities
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, King’s 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 Office’s 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 Trust’s 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.
Person specification
Skills, Knowledge & Abilities
Essential criteria- Ability to work constructively as an individual; as part of a close-knit team; and as part of a wider research community.
- Excellent IT literacy: evidence of competence with MS Office, particularly Excel, Word and PowerPoint.
- Ability to summarise and explain complex regulatory and research issues to all grades of staff; ability to understand and analyse complex research protocols.
- Project management skills
- Giving presentations, undertaking training and briefing sessions.
Previous experience
Essential criteria- At least 5 years’ experience of working in the NHS or Academia within a relevant clinical research environment.
- Significant experience of clinical research management, to include experience in the planning, coordination and conducting of clinical research studies or the management of clinical research.
- Ability to work on own initiative, good team worker, ability to prioritise and balance work priorities
- Experience of research in a clinical environment
- Experience of managing Quality Management Systems
- Knowledge of the processes required to set up and conduct clinical trials.
Qualifications & Education
Essential criteria- Post graduate qualification, related to biomedical sciences or similar, (or the equivalent relevant education and experience) in a discipline relevant to clinical research, clinical trials or their regulatory oversight.
- Previous management skills/relevant professional qualification e.g. project management
- Clinical Background
Guy’s and St Thomas’ celebrates, respects and values the diversity of its staff and patients. We review our policies, procedures and practices to ensure that all employees, patients and carers are treated equitable according to their needs. We are actively committed to ensuring that no one who applies for a job, works or study’s at the Trust, or accesses our services is discriminated against on the grounds of race, ethnicity, nationality, disability, religion or belief, age, gender identity , gender reassignment, sexual orientation, pregnancy and maternity/paternity, or marital/civil partnership.
Applications are welcomed from applicants with a disability. We can make reasonable adjustments and offer support and advice in a variety of ways throughout the application process. Equality of opportunity is our policy.
As an organisation we are committed to developing our services in ways that best suit the needs of our patients. This means that some staff groups will increasingly be asked to work a more flexible shift pattern so that we can offer services in the evenings or at weekends.
Flexible working
We are committed to supporting all employees to achieve a healthy work life balance and to work in a way that is best for them and our patients. We will consider all requests to work flexibly, taking in to account the individual’s personal circumstances as well the needs of the service.We encourage all prospective applicants to discuss their individual circumstances with the recruiting manager as part of the on-boarding process.
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