Clinical Research Facility Business and Operations Manager
| Posting date: | 22 May 2024 |
|---|---|
| Salary: | Not specified |
| Additional salary information: | £58,698 - £65,095 per annum incl. HCA |
| Hours: | Full time |
| Closing date: | 21 June 2024 |
| Location: | London, SE1 9RT |
| Company: | Guys and St Thomas NHS Foundation Trust |
| Job type: | Permanent |
| Job reference: | 6306927/196-RD101 |
Summary
A Vacancy at Guy's and St Thomas' NHS Foundation Trust.
The post holder will provide strong operational and management support to the 5 specialist CRF units to ensure the effective use of infrastructure and resources. The post holder will work alongside the CRF Directors and other senior operational leads to ensure the timely delivery of a large and diverse portfolio of commercial and non-commercial studies undertaken in the CRF (including first-in-human Phase 1 trials and other experimental medicine studies), while ensuring compliance with regulatory research frameworks. They will be responsible for monitoring financial activity against agreed budgets, and for the development and implementation of comprehensive operational business plans and business cases for additional financial support, when appropriate. The post holder will drive the strategic development of the CRF, including working to strengthen links and collaborations with partner organisations and other NIHR funded infrastructure. The post holder will contribute to the development of national CRF policies and initiatives through participation in the UK CRF Network.
The Research and Development (R&D) Department
The R&D Department at Guy’s & St Thomas’ NHS Foundation Trust (GSTFT) is one of the focal points for innovative research in London through its nationally recognised research portfolio and research infrastructure. We are systems leaders in NHS research with strong strategic partnerships
across the National Institute for Health Research (NIHR), Department of Health & Social Care (DHSC) and the Health Research Authority (HRA) and are active members of the organisations such as the Shelford Group, University Hospitals Association (previously AUKUH) and UKRD.
Research is a top priority for the Trust which in 2021/22 was the top NHS organisation nationally for the number of NIHR portfolio studies open (417) and was the top recruiting organisation in South
London (third nationally) recruiting over 19,000 participants into NIHR portfolio studies. This is approximately over 40% of the total number of participants of research studies within our Local Clinical Research Network in South London. For the financial year 2022/23, the NIHR budget for
the R&D Department totalled approximately £25m. We are a the most active research partner in the King’s Health Partners Clinical Trials Office for contract commercial clinical trials with 60% of the commercial trials portfolio in 2021/22 lead by the Trust; we also collaborate in the South London NIHR Applied Research Collaboration (ARC).
Our research infrastructure includes our NIHR Clinical Research Facility (CRF) located St Thomas’ Hospital, Guy’s Hospital, Evelina London Children’s Hospital and the Royal Brompton Hospital; the
Guy’s Phase I unit is an MHRA Accredited Phase I Unit (1 of only 2 NHS managed Units in England). Within the Biomedical Hub at Guy’s Hospital, the NIHR CRF is co-located with our Advanced Therapies Manufacturing (GMP) Unit, which is currently undergoing an expansion by an
additional two clean rooms (60% increase in capacity); the Advanced Therapies Accelerator houses our Immune Monitoring Platform and Genomics Platform. These are supported by the Statistics and
Data Management Platform and a Clinical Trials Management. A Med Tech Hub exists at St Thomas’ Hospital which incorporates the Imaging arm of our CRF, the pan-London 7T MRI scanner and the InnovateUK London Medical Imaging and AI Centre for Value Based Healthcare.
The Trust was also awarded an NIHR Healthtech Research Centre infrastructure award which replaces the Medtech and In vitro Diagnostics Collaboratives (MIC) which the Trust held until 2024.
The £3m award over 5 years will support building on existing expertise and the development of novel technologies, devices, diagnostics and digital solutions designed to improve health and care and speed up translation of new technologies into clinical practice.
The Trust holds the contract to host the NIHR Clinical Research Network in South London - one of only 15 NHS organisations in England to host a Local Clinical Research Network (LCRN). The Trust, in partnership with the University of Leeds, was awarded the contract from the Department
3 of Health to provide the NIHR Clinical Research Network Coordinating Centre (NIHR CRNCC) since 2015, which allows the Trust to influence research activity at a national level.
We have a large research workforce across the Trust including a range of technical experts, researchers, research support staff, research nurses, research delivery staff and administrative staff. Based in offices within the Tower Wing at Guy’s Hospital we are co-located with the South
London CRN and Clinical Trials Office, creating a dynamic, lively and diverse research department has the breadth of knowledge and skills to ensure that this high level of research activity and associated research processes are managed smoothly, efficiently and collaboratively.
• Strategic development of the CRF
• Financial management
• Facilities management
• Human Resources management
• Operational management and leadership
• Communication and networking
• Educational and Training
• Key Relationships
• Confidentiality / Data Protection / Freedom of Information
• Information Governance
• Equal Opportunities
• Health and Safety
• Infection Control
• Risk Management
• Flexible Working
• Safeguarding children and vulnerable adults
• Sustainability
Guy’s and St Thomas’ NHS Foundation Trust comprises five of the UK’s best-known hospitals – Guy’s, St Thomas’, Evelina London Children’s Hospital, Royal Brompton and Harefield – as well as community services in Lambeth and Southwark, all with a long history of high-quality care, clinical excellence, research and innovation.
We are among the UK’s busiest, most successful foundation trusts. We provide specialist care for patients including heart and lung, cancer and renal services as well as a full range of local hospital and community services for people in Lambeth and Southwark.
We have a long tradition of clinical and scientific achievement and – as part of King’s Health Partners – we are one of England’s eight academic health sciences centres, bringing together world-class clinical services, teaching and research.
We strive to recruit and retain the best staff as the dedication and skills of our employees lie at the heart of our organisation and ensure that our services are of the highest quality, safe and focused on our patients.
Strategic Development of the CRF:
a) Lead on the development and implementation of a comprehensive operational business plan and business cases as required for additional financial support and resource to both internal and external audiences.
b) Responsible for the development of research functions and future service delivery requirements of the adult CRFs in order to support commercial and non-commercial/academic research studies.
c) Responsible for the development of key performance indicators and metrics including occupancy data in order to ensure accurate reporting of activities to the CRF Directors, BRC and R&D Departments, and the NIHR.
d) Responsible for reporting the CRF metrics nationally to the NIHR in line with thecontractual obligations of our NIHR CRF funding, and locally within the CRF, BRC and R&D governance structures.
e) Provide expert advice and information to support the development of key strategic external peer reviewed infrastructure bids relevant to the CRF and the development of the strategic vision for the CRF.
f) Working in conjunction with the adult CRF Nurse Manager, develop and maintain productive working relationships with pharmaceutical companies and the biotechnology industry partners in order to create and sustain the sound business relationships, strategic partnerships and business alliances needed to attract commercial research activities to the CRF.
g) Liaise with multiple external agencies and internal departments to promote and facilitate the establishment of new clinical research studies within the adult facilities.
h) Ensure that participant feedback/complaints are reported, investigated and responded to appropriately in order to improve service delivery developments and patient experience.
i) Contribute to the development of national CRF policies and initiatives through participation in the UK CRF Network and be responsible for dissemination and implementation of national initiatives within the CRF.
j) Responsible for developing strategies to ensure effective collaboration with other BRC Core Facilities such as the Good Manufacturing Practice Unit and the Immune Monitoring and Flow Cytometry cores to allow the seamless transition of research activities between these facilities.
k) Responsible for the strategic working relationship with other CRFs within King’s Health Partners in order to increase and maximise operational efficiencies where appropriate and to share best practice.
l) Play a lead role as an Executive member of the CRF Management Team, CRF Review Board and Operations meetings as well as BRC Management meetings.
Financial Management
a) Lead on the development of a robust financial plan and cost recovery system for the CRF for both commercial and non-commercial research activity including the generation of income targets and monitoring of activity against such targets.
b) Responsible for management of the adult CRF budget from both the NIHR CRF funding award and the delegated BRC budget, ensuring income capture, adherence to agreed budget plans, identifying savings and costs reduction in conjunction with the relevant Research Management Accountants/Financial Analysts to ensure budgets are up to date and accurate, making adjustments where required.
c) Delegated signatory of up to£5k.
d) Responsible for identifying costs pressures, service development and cost improvement plans and to present data on performance as required.
e) Responsible for the management and maintenance of the CRF’s Asset Register on behalf of the BRC and management of any relevant associated service or maintenance contracts.
Facilities Management
a) To be responsible for the ongoing management and maintenance of the building, equipment and facilities, ensuring the CRF provides an environment conducive to supporting high quality clinical research in line with relevant regulatory frameworks.
b) To promptly resolve any unexpected operational problems impacting on service users and safety.
c) To be responsible for the procurement of all new equipment, furniture and fittings and to ensure purchases are underpinned by maintenance contracts where appropriate.
d) To develop and maintain inventories/databases appropriate for good resource management and ensure that systems are in place for safety testing, servicing and maintenance as appropriate.
e) Liaise with the Trust’s estates and facilities department and external suppliers in planning and implementing any repairs, improvements or other building works.
f) Develop and implement a security policy for the unit and put systems in place to ensure the ongoing safety and security of staff, children and their families and investigators.
g) Negotiate the annual service level agreements (e.g. the provision of cleaning services) formulated between the CRF and other service departments within the Trust, ensuring they are submitted and reviewed in a timely manner and that value for money is obtained. Act as the primary Health and Safety and Fire representative for the unit, ensuring there is an appropriate H&S structure in place to provide a suitable environment for conducting multi-disciplinary clinical research which is compliant with statutory requirements. Conduct risk analyses as appropriate.
Human Resources
a) Maintain a system of regular performance review and annual appraisals for all staff ensuring training and development needs are identified and met. Ensure appropriate mentors are available to all disciplines of CRF staff.
b) Provide line manage for key CRF staff and lead on recruitment, induction, appraisal, training and development and retention of CRF staff as well as managing sickness and absence, disciplinary and performance issues that may arise.
c) Develop workforce plans which anticipate service changes and developments and which address recruitment, retention and workforce supply issues to minimise the impact of these on service delivery.
d) Lead and support organisational change to ensure efficient service delivery, productivity and compliance with Trust and CRF goals. This could include consultation with staff and promoting new ways of working, implementing new policies and procedures.
Operational Management and Leadership
a) Deputise for the CRF Director, Deputy Director and BRC Platforms Manager as required.
b) Overall responsibility for the day to day operational management of the adult Clinical Research Facilities including operational planning to establish appropriate resources and capacity to deliver the forthcoming pipeline of clinical research in the CRF.
d) In collaboration with the adult CRF Nurse Managers, provide operational leadership ensuring there is a clear framework for the delivery of high quality care and clinical research and that best practice is maintained at all times.
e) Set, monitor, implement and seek to continuously improve adult CRF services in line with MHRA Phase I Accreditation, Good Clinical Practice, Research and Clinical Governance, Health and Safety, Data Protection, Infection Control and Ethics.
f) Ensure that all Trust policies including child protection, vulnerable adult and Human Tissue Act legislation are adhered to by CRF staff.
g) Lead by example and act as a positive role model for all staff, taking responsibility for your own professional development.
h) Maintain personal standards of conduct and behaviour, which are consistent with Trust and professional standards and requirements, ensuring these standards are achieved.
Communication and Networking
a) Responsible for representing the CRF and the BRC at relevant internal and external meetings and conferences (national and international as required).
b) Act as the lead on developing, maintaining and fostering strategic links with other national CRFs and the UK CRF Network including representation at the pan-London CRF Network.
c) Responsible for promoting a positive image of the CRFs at all times especially promoting the CRFs as centres of clinical excellence for undertaking research activities in order to attract new business activities to the facility, both in the academic/NHS arena and the commercial sector.
d) Responsible for promoting the CRF by proactively targeting clinical academics, research groups and organisations, building effective management links and networks with the Clusters within the BRC, Trust departments and the College, in order to ensure efficient management and development of research collaborations in relation to CRF activities.
e) Establish and maintain strong links with surrounding NHS and academic partners particularly King’s College Hospital NHS Foundation Trust and South London and Maudsley NHS Foundation Trust within King’s Health Partners.
f) Responsible for developing the patient and public involvement strategy for the CRF in partnership with the BRC, encompassing participation in Trust, UKCRF Network open days, BRC promotional events and also Trust events relating to public engagement in research.
g) Act as the Trust lead in relation to showcasing the CRF in terms of infrastructure facilities and operational management, and provide advice and guidance to external visitors including government and charitable organisations on the development and management of further CRFs across the country.
Educational and Training
a) Facilitate the development of skills in clinical research and ensure training and development opportunities are available to all disciplines of CRF staff.
b)Create and promote an appropriate learning environment across the CRFs.
This advert closes on Sunday 9 Jun 2024
The post holder will provide strong operational and management support to the 5 specialist CRF units to ensure the effective use of infrastructure and resources. The post holder will work alongside the CRF Directors and other senior operational leads to ensure the timely delivery of a large and diverse portfolio of commercial and non-commercial studies undertaken in the CRF (including first-in-human Phase 1 trials and other experimental medicine studies), while ensuring compliance with regulatory research frameworks. They will be responsible for monitoring financial activity against agreed budgets, and for the development and implementation of comprehensive operational business plans and business cases for additional financial support, when appropriate. The post holder will drive the strategic development of the CRF, including working to strengthen links and collaborations with partner organisations and other NIHR funded infrastructure. The post holder will contribute to the development of national CRF policies and initiatives through participation in the UK CRF Network.
The Research and Development (R&D) Department
The R&D Department at Guy’s & St Thomas’ NHS Foundation Trust (GSTFT) is one of the focal points for innovative research in London through its nationally recognised research portfolio and research infrastructure. We are systems leaders in NHS research with strong strategic partnerships
across the National Institute for Health Research (NIHR), Department of Health & Social Care (DHSC) and the Health Research Authority (HRA) and are active members of the organisations such as the Shelford Group, University Hospitals Association (previously AUKUH) and UKRD.
Research is a top priority for the Trust which in 2021/22 was the top NHS organisation nationally for the number of NIHR portfolio studies open (417) and was the top recruiting organisation in South
London (third nationally) recruiting over 19,000 participants into NIHR portfolio studies. This is approximately over 40% of the total number of participants of research studies within our Local Clinical Research Network in South London. For the financial year 2022/23, the NIHR budget for
the R&D Department totalled approximately £25m. We are a the most active research partner in the King’s Health Partners Clinical Trials Office for contract commercial clinical trials with 60% of the commercial trials portfolio in 2021/22 lead by the Trust; we also collaborate in the South London NIHR Applied Research Collaboration (ARC).
Our research infrastructure includes our NIHR Clinical Research Facility (CRF) located St Thomas’ Hospital, Guy’s Hospital, Evelina London Children’s Hospital and the Royal Brompton Hospital; the
Guy’s Phase I unit is an MHRA Accredited Phase I Unit (1 of only 2 NHS managed Units in England). Within the Biomedical Hub at Guy’s Hospital, the NIHR CRF is co-located with our Advanced Therapies Manufacturing (GMP) Unit, which is currently undergoing an expansion by an
additional two clean rooms (60% increase in capacity); the Advanced Therapies Accelerator houses our Immune Monitoring Platform and Genomics Platform. These are supported by the Statistics and
Data Management Platform and a Clinical Trials Management. A Med Tech Hub exists at St Thomas’ Hospital which incorporates the Imaging arm of our CRF, the pan-London 7T MRI scanner and the InnovateUK London Medical Imaging and AI Centre for Value Based Healthcare.
The Trust was also awarded an NIHR Healthtech Research Centre infrastructure award which replaces the Medtech and In vitro Diagnostics Collaboratives (MIC) which the Trust held until 2024.
The £3m award over 5 years will support building on existing expertise and the development of novel technologies, devices, diagnostics and digital solutions designed to improve health and care and speed up translation of new technologies into clinical practice.
The Trust holds the contract to host the NIHR Clinical Research Network in South London - one of only 15 NHS organisations in England to host a Local Clinical Research Network (LCRN). The Trust, in partnership with the University of Leeds, was awarded the contract from the Department
3 of Health to provide the NIHR Clinical Research Network Coordinating Centre (NIHR CRNCC) since 2015, which allows the Trust to influence research activity at a national level.
We have a large research workforce across the Trust including a range of technical experts, researchers, research support staff, research nurses, research delivery staff and administrative staff. Based in offices within the Tower Wing at Guy’s Hospital we are co-located with the South
London CRN and Clinical Trials Office, creating a dynamic, lively and diverse research department has the breadth of knowledge and skills to ensure that this high level of research activity and associated research processes are managed smoothly, efficiently and collaboratively.
• Strategic development of the CRF
• Financial management
• Facilities management
• Human Resources management
• Operational management and leadership
• Communication and networking
• Educational and Training
• Key Relationships
• Confidentiality / Data Protection / Freedom of Information
• Information Governance
• Equal Opportunities
• Health and Safety
• Infection Control
• Risk Management
• Flexible Working
• Safeguarding children and vulnerable adults
• Sustainability
Guy’s and St Thomas’ NHS Foundation Trust comprises five of the UK’s best-known hospitals – Guy’s, St Thomas’, Evelina London Children’s Hospital, Royal Brompton and Harefield – as well as community services in Lambeth and Southwark, all with a long history of high-quality care, clinical excellence, research and innovation.
We are among the UK’s busiest, most successful foundation trusts. We provide specialist care for patients including heart and lung, cancer and renal services as well as a full range of local hospital and community services for people in Lambeth and Southwark.
We have a long tradition of clinical and scientific achievement and – as part of King’s Health Partners – we are one of England’s eight academic health sciences centres, bringing together world-class clinical services, teaching and research.
We strive to recruit and retain the best staff as the dedication and skills of our employees lie at the heart of our organisation and ensure that our services are of the highest quality, safe and focused on our patients.
Strategic Development of the CRF:
a) Lead on the development and implementation of a comprehensive operational business plan and business cases as required for additional financial support and resource to both internal and external audiences.
b) Responsible for the development of research functions and future service delivery requirements of the adult CRFs in order to support commercial and non-commercial/academic research studies.
c) Responsible for the development of key performance indicators and metrics including occupancy data in order to ensure accurate reporting of activities to the CRF Directors, BRC and R&D Departments, and the NIHR.
d) Responsible for reporting the CRF metrics nationally to the NIHR in line with thecontractual obligations of our NIHR CRF funding, and locally within the CRF, BRC and R&D governance structures.
e) Provide expert advice and information to support the development of key strategic external peer reviewed infrastructure bids relevant to the CRF and the development of the strategic vision for the CRF.
f) Working in conjunction with the adult CRF Nurse Manager, develop and maintain productive working relationships with pharmaceutical companies and the biotechnology industry partners in order to create and sustain the sound business relationships, strategic partnerships and business alliances needed to attract commercial research activities to the CRF.
g) Liaise with multiple external agencies and internal departments to promote and facilitate the establishment of new clinical research studies within the adult facilities.
h) Ensure that participant feedback/complaints are reported, investigated and responded to appropriately in order to improve service delivery developments and patient experience.
i) Contribute to the development of national CRF policies and initiatives through participation in the UK CRF Network and be responsible for dissemination and implementation of national initiatives within the CRF.
j) Responsible for developing strategies to ensure effective collaboration with other BRC Core Facilities such as the Good Manufacturing Practice Unit and the Immune Monitoring and Flow Cytometry cores to allow the seamless transition of research activities between these facilities.
k) Responsible for the strategic working relationship with other CRFs within King’s Health Partners in order to increase and maximise operational efficiencies where appropriate and to share best practice.
l) Play a lead role as an Executive member of the CRF Management Team, CRF Review Board and Operations meetings as well as BRC Management meetings.
Financial Management
a) Lead on the development of a robust financial plan and cost recovery system for the CRF for both commercial and non-commercial research activity including the generation of income targets and monitoring of activity against such targets.
b) Responsible for management of the adult CRF budget from both the NIHR CRF funding award and the delegated BRC budget, ensuring income capture, adherence to agreed budget plans, identifying savings and costs reduction in conjunction with the relevant Research Management Accountants/Financial Analysts to ensure budgets are up to date and accurate, making adjustments where required.
c) Delegated signatory of up to£5k.
d) Responsible for identifying costs pressures, service development and cost improvement plans and to present data on performance as required.
e) Responsible for the management and maintenance of the CRF’s Asset Register on behalf of the BRC and management of any relevant associated service or maintenance contracts.
Facilities Management
a) To be responsible for the ongoing management and maintenance of the building, equipment and facilities, ensuring the CRF provides an environment conducive to supporting high quality clinical research in line with relevant regulatory frameworks.
b) To promptly resolve any unexpected operational problems impacting on service users and safety.
c) To be responsible for the procurement of all new equipment, furniture and fittings and to ensure purchases are underpinned by maintenance contracts where appropriate.
d) To develop and maintain inventories/databases appropriate for good resource management and ensure that systems are in place for safety testing, servicing and maintenance as appropriate.
e) Liaise with the Trust’s estates and facilities department and external suppliers in planning and implementing any repairs, improvements or other building works.
f) Develop and implement a security policy for the unit and put systems in place to ensure the ongoing safety and security of staff, children and their families and investigators.
g) Negotiate the annual service level agreements (e.g. the provision of cleaning services) formulated between the CRF and other service departments within the Trust, ensuring they are submitted and reviewed in a timely manner and that value for money is obtained. Act as the primary Health and Safety and Fire representative for the unit, ensuring there is an appropriate H&S structure in place to provide a suitable environment for conducting multi-disciplinary clinical research which is compliant with statutory requirements. Conduct risk analyses as appropriate.
Human Resources
a) Maintain a system of regular performance review and annual appraisals for all staff ensuring training and development needs are identified and met. Ensure appropriate mentors are available to all disciplines of CRF staff.
b) Provide line manage for key CRF staff and lead on recruitment, induction, appraisal, training and development and retention of CRF staff as well as managing sickness and absence, disciplinary and performance issues that may arise.
c) Develop workforce plans which anticipate service changes and developments and which address recruitment, retention and workforce supply issues to minimise the impact of these on service delivery.
d) Lead and support organisational change to ensure efficient service delivery, productivity and compliance with Trust and CRF goals. This could include consultation with staff and promoting new ways of working, implementing new policies and procedures.
Operational Management and Leadership
a) Deputise for the CRF Director, Deputy Director and BRC Platforms Manager as required.
b) Overall responsibility for the day to day operational management of the adult Clinical Research Facilities including operational planning to establish appropriate resources and capacity to deliver the forthcoming pipeline of clinical research in the CRF.
d) In collaboration with the adult CRF Nurse Managers, provide operational leadership ensuring there is a clear framework for the delivery of high quality care and clinical research and that best practice is maintained at all times.
e) Set, monitor, implement and seek to continuously improve adult CRF services in line with MHRA Phase I Accreditation, Good Clinical Practice, Research and Clinical Governance, Health and Safety, Data Protection, Infection Control and Ethics.
f) Ensure that all Trust policies including child protection, vulnerable adult and Human Tissue Act legislation are adhered to by CRF staff.
g) Lead by example and act as a positive role model for all staff, taking responsibility for your own professional development.
h) Maintain personal standards of conduct and behaviour, which are consistent with Trust and professional standards and requirements, ensuring these standards are achieved.
Communication and Networking
a) Responsible for representing the CRF and the BRC at relevant internal and external meetings and conferences (national and international as required).
b) Act as the lead on developing, maintaining and fostering strategic links with other national CRFs and the UK CRF Network including representation at the pan-London CRF Network.
c) Responsible for promoting a positive image of the CRFs at all times especially promoting the CRFs as centres of clinical excellence for undertaking research activities in order to attract new business activities to the facility, both in the academic/NHS arena and the commercial sector.
d) Responsible for promoting the CRF by proactively targeting clinical academics, research groups and organisations, building effective management links and networks with the Clusters within the BRC, Trust departments and the College, in order to ensure efficient management and development of research collaborations in relation to CRF activities.
e) Establish and maintain strong links with surrounding NHS and academic partners particularly King’s College Hospital NHS Foundation Trust and South London and Maudsley NHS Foundation Trust within King’s Health Partners.
f) Responsible for developing the patient and public involvement strategy for the CRF in partnership with the BRC, encompassing participation in Trust, UKCRF Network open days, BRC promotional events and also Trust events relating to public engagement in research.
g) Act as the Trust lead in relation to showcasing the CRF in terms of infrastructure facilities and operational management, and provide advice and guidance to external visitors including government and charitable organisations on the development and management of further CRFs across the country.
Educational and Training
a) Facilitate the development of skills in clinical research and ensure training and development opportunities are available to all disciplines of CRF staff.
b)Create and promote an appropriate learning environment across the CRFs.
This advert closes on Sunday 9 Jun 2024