Job summary
The Study Support Service supports researchers in the development, planning, set-up, feasibility, delivery and performance management of the NIHR Clinical Research portfolio across the region, with specific focus on Divisions 1 & 3 which include the following specialties; Cancer, Non-malignant Haematology, Genetics, Children and Reproductive Health & Child Birth. .
The National Institute for Health Research (NIHR) Clinical Research Network is the clinical research delivery arm of the NHS in England, tasked with supporting the rapid set-up and effective conduct of studies, so that researchers can gather the robust evidence needed to improve treatments for NHS patients. The CRN consists of many different organisations, NHS trusts including 16 NHS Trusts in Derbyshire, Leicestershire, Lincolnshire, Nottinghamshire, Northampton and Rutland. 19 CCGs, Independent Providers of NHS Services across the region, Local Authorities and Care Homes where service support and infrastructure are required to enable patient participation in research across a diverse population of 4.3million.
Post-Covid we have embraced a hybrid model of office and home working, with our offices based at Leicester Royal Infirmary and Queen's Medical Centre. However there will still be a requirement to travel throughout the region, and occasionally further afield, you must be able to demonstrate that you have access to a vehicle or other means of travel to these locations.
Main duties of the job
The Study Support Service Manager will manage the Division 1 & 3 Study Support Service team within the CRN to deliver a robust and professional research management service to NHS Trusts and Stakeholders across the East Midlands area. The post holder will provide day to day line management of the Facilitators, Co-ordinators and supervision of other staff within the Study Support Service team. The service will be in all care settings and throughout the research pathway.
About us
We are one of the biggest and busiest NHS trusts in the country, incorporating the General, Glenfield and Royal Infirmary hospitals. We have our very own Children's Hospital and run one of the country's leading heart centres.
Our team is made up of more than 17,000 staff providing a range of services primarily for the one million residents of Leicester, Leicestershire and Rutland.
We work with partners at the University of Leicester and De Montfort University providing world-class teaching to nurture and develop the next generation of doctors, nurses and other healthcare professionals, many of whom go on to spend their working lives with us.
Our purpose is to provide 'Caring at its best' and our staff have helped us create a set of values that embody who we are and what we're here to do. They are:We focus on what matters mostWe treat others how we would like to be treatedWe are passionate and creative in our workWe do what we say we are going to doWe are one team and we are best when we work togetherOur patients are at the heart of all we do and we believe that 'Caring at its best' is not just about the treatments and services we provide, but about giving our patients the best possible experience.
About the University Hospitals of Leicester NHS Trust (leicestershospitals.nhs.uk)
Job description
Job responsibilities
Delivery of the Study Support Service within Division 1 & 3, ensuring researchers are supported through the study pathway including, Early Contact & Engagement, Site Identification, Effective Study Start Up and Performance Monitoring.
Work closely with the Research Delivery Manager, Research Operations Manager, and Trust R&D/I to promote the importance of research, and build strong working relationships within the Study Support Service team and with staff in partner Trusts who have a responsibility for R&D/I to ensure that they continue to comply with NIHR CRN directives and guidance to deliver portfolio studies.
KEY RESULT AREAS
- Delivery of the Key Components of SSS as per National Guidance and Standard Operating Procedures Project management
- Data management and reporting
- Communication, training and education
- Line management
- Regulatory inspections
STAFF
The post holder will directly line manage x2 Study Support Service (SSS) Senior Facilitators and will provide leadership to the Divisional SSS Team. For those directly managing the post holder is required to undertake all aspects of performance, attendance, training and appraisal in accordance with Trust Policy; for the wider team within the scope of the role, the post-holder will also ensure this is undertaken.
KEY WORKING RELATIONSHIPS
- All Research staff across the East Midlands at all levels, both clinical and non-clinical
- CRN East Midlands Study Support Service Compliance and Assurance Manager and Research Delivery Managers/Operational Managers
- CRN East Midlands Divisional Clinical Research Leads and Clinical Research Specialty Leads in the relevant Divisions
- CRN East Midlands Industry, Delivery and Operational teams
- Other CRN study support colleagues across England
- CRN East Midlands partner NHS Trusts and other service providers (R&D Leads, Directors, Managers, support and delivery teams)
- NHS Research Managers and support service departments (e.g. radiology, Pharmacy)
- East Midlands wider research community
- Patient and carer groups/organisations and forums as relevant
- External research commercial and noncommercial sponsors and funders
- Affiliated organisations where required: University Partners, CCGs, LATS, Community Trusts, NIHR Partners i.e. BRC, ARC etc
- The Life Sciences Industry
Job description
Job responsibilities
Delivery of the Study Support Service within Division 1 & 3, ensuring researchers are supported through the study pathway including, Early Contact & Engagement, Site Identification, Effective Study Start Up and Performance Monitoring.
Work closely with the Research Delivery Manager, Research Operations Manager, and Trust R&D/I to promote the importance of research, and build strong working relationships within the Study Support Service team and with staff in partner Trusts who have a responsibility for R&D/I to ensure that they continue to comply with NIHR CRN directives and guidance to deliver portfolio studies.
KEY RESULT AREAS
- Delivery of the Key Components of SSS as per National Guidance and Standard Operating Procedures Project management
- Data management and reporting
- Communication, training and education
- Line management
- Regulatory inspections
STAFF
The post holder will directly line manage x2 Study Support Service (SSS) Senior Facilitators and will provide leadership to the Divisional SSS Team. For those directly managing the post holder is required to undertake all aspects of performance, attendance, training and appraisal in accordance with Trust Policy; for the wider team within the scope of the role, the post-holder will also ensure this is undertaken.
KEY WORKING RELATIONSHIPS
- All Research staff across the East Midlands at all levels, both clinical and non-clinical
- CRN East Midlands Study Support Service Compliance and Assurance Manager and Research Delivery Managers/Operational Managers
- CRN East Midlands Divisional Clinical Research Leads and Clinical Research Specialty Leads in the relevant Divisions
- CRN East Midlands Industry, Delivery and Operational teams
- Other CRN study support colleagues across England
- CRN East Midlands partner NHS Trusts and other service providers (R&D Leads, Directors, Managers, support and delivery teams)
- NHS Research Managers and support service departments (e.g. radiology, Pharmacy)
- East Midlands wider research community
- Patient and carer groups/organisations and forums as relevant
- External research commercial and noncommercial sponsors and funders
- Affiliated organisations where required: University Partners, CCGs, LATS, Community Trusts, NIHR Partners i.e. BRC, ARC etc
- The Life Sciences Industry
Person Specification
Training & Qualifications
Essential
- oFirst degree or equivalent experience
- oEvidence of continuing professional development.
- oWorking knowledge and relevant training in ICH GCP
Desirable
- oMSc or equivalent relevant experience
Experience
Essential
- oAt least 5 years management experience within the NHS or equivalent public sector settings.
- oExperience of developing/delivering training.
- oExperience of managing of supervising other members of staff.
- oKnowledge of the research process and research issues applicable to health settings.
- oWorking knowledge of Department of Health AcoRD guidance
- oKnowledge of research management arrangements for NHS studies.
- oKnowledge of the CRN Study Support Service research governance.
- oAn understanding of the importance of maintaining security and confidentiality of information.
- oKnowledge of the NIHR Clinical Research Network, particularly a sound understanding of the role of Local Clinical Research Networks (LCRNs).
- oExperience of managing specialists teams in a changing environment.
- oExpert specialist knowledge of the regulatory framework around research
- oExperience of reviewing studies and/or service evaluation projects for quality, governance, financial, legal and data protection issues.
- oExperience of working with databases and using reporting tools.
- oPractical working knowledge of Microsoft Word, Access, PowerPoint, e-mail and the Internet
Desirable
- oClinical trial management experience (Commercial /Non Commercial
- oExperience of costing research.
- oAn understanding of audit and monitoring procedures for research studies.
- oExperience of managing service evaluation/clinical audit and/or research projects (NHS, University or Industry).
- oKnowledge of Google Suite Applications
Communication & relationship skills
Essential
- oAbility to communicate complex information clearly, both in writing and orally, to a range of audiences at both local and national level
- oAbility to present and explain information in a manner that can be understood easily by non-specialists
- oAbility to communicate with staff at all levels in a calm and professional manner
- oAbility to build excellent working relationships
- oAbility to deliver feedback in a positive, constructive manner.
- oAbility to manage challenging behaviour and difficult situations in a diplomatic and professional manner
- oExcellent negotiation skills
- oAbility to communicate with industry sponsors and build relationships while remaining professional and presenting a positive representation of both the East Midlands LCRN and Stakeholders.
- oAbility to persuade and positively influence other team members and work colleagues.
Analytical and Judgement skills
Essential
- oAbility to read, digest and interpret complex documents including European and National legislation, Department of Health policies and guidance, research agreements.
- oAbility to accurately interpret and present data in appropriate formats.
- oAbility to process specialist and complex information and present as appropriate.
- oAbility to absorb information from several sources quickly and be able to make well informed judgements in a timely manner.
- oAbility to learn new information, procedures and processes in a limited time period. E.g. familiarise oneself with a complex study to be able to support researchers or Industry Team at the coordinating centre with tasks that require completing within short deadlines
- oExcellent problem solving skills with the ability to make well informed decisions on a continuous basis.
Skills
Essential
- oSelf-motivated and flexible.
- oEvidence of continued professional development.
- oEvidence of implementing successful and sustainable change.
- oSelf-confidence and ability to cope under pressure.
- oAble to learn new skills and apply these in the workplace.
- oCan work both independently and as part of a team
- oAbility to motivate themselves and others
- oSelf -awareness and understanding of own strengths and limitations and impact of personal style and approach on others
- oCommitment to openness, honesty, inclusiveness and personal integrity in dealing with others
- oCommitment to continuing professional development
- oSets and achieves high standards for own behaviour and personal presentation
Planning and organisation skills
Essential
- oExcellent planning and organisational skills, with the ability to prioritise and work to multiple deadlines
- oRecord of managing work streams/projects simultaneously and delivering to tight deadlines
- oCapacity to formulate short and long term objectives
- oAbility to prioritise and manage own workload and that of others and respond appropriately to deadlines
- oAble to demonstrate the personal development of members within a team
- oAbility to plan and organise a large and varied workload and complete tasks within a tight time frame.
- oDevelopment of key policies and responsibility for keeping them up to date.
- oAbility to work to local and national deadlines, objectives and targets.
- oAbility to work to deadlines when completing study budgets and contract negotiations and other designated time lines
- oAbility to identify and establish agreed workload/tasks with study site teams, Industry sponsors/contract research organisations, CRN and LCRN team members and other NHS organisation contacts
- oAbility to work independently
Equality, Diversity and Inclusion
Essential
- oAble to demonstrate a commitment to and understanding of the importance of treating all individuals with dignity and respect appropriate to their individual needs.
- oAll staff are expected to engage in compassionate and inclusive leadership in the provision of high quality care and interactions with others
Other requirements specific to the role
Essential
- oAbility to travel between the sites in the East Midlands region and nationally as required
- oEngages with and promotes continuous improvement projects
- oWilling to work flexibly across the area
- oWilling to use "hot desking" facilities
- oAbility to use manual handling skills to transport documentation and equipment in a safe manner.
- oAbility to work for long periods on a computer. Use of a keyboard on a daily basis
- oAbility to be able to manage long periods of concentration and pressured work.
Person Specification
Training & Qualifications
Essential
- oFirst degree or equivalent experience
- oEvidence of continuing professional development.
- oWorking knowledge and relevant training in ICH GCP
Desirable
- oMSc or equivalent relevant experience
Experience
Essential
- oAt least 5 years management experience within the NHS or equivalent public sector settings.
- oExperience of developing/delivering training.
- oExperience of managing of supervising other members of staff.
- oKnowledge of the research process and research issues applicable to health settings.
- oWorking knowledge of Department of Health AcoRD guidance
- oKnowledge of research management arrangements for NHS studies.
- oKnowledge of the CRN Study Support Service research governance.
- oAn understanding of the importance of maintaining security and confidentiality of information.
- oKnowledge of the NIHR Clinical Research Network, particularly a sound understanding of the role of Local Clinical Research Networks (LCRNs).
- oExperience of managing specialists teams in a changing environment.
- oExpert specialist knowledge of the regulatory framework around research
- oExperience of reviewing studies and/or service evaluation projects for quality, governance, financial, legal and data protection issues.
- oExperience of working with databases and using reporting tools.
- oPractical working knowledge of Microsoft Word, Access, PowerPoint, e-mail and the Internet
Desirable
- oClinical trial management experience (Commercial /Non Commercial
- oExperience of costing research.
- oAn understanding of audit and monitoring procedures for research studies.
- oExperience of managing service evaluation/clinical audit and/or research projects (NHS, University or Industry).
- oKnowledge of Google Suite Applications
Communication & relationship skills
Essential
- oAbility to communicate complex information clearly, both in writing and orally, to a range of audiences at both local and national level
- oAbility to present and explain information in a manner that can be understood easily by non-specialists
- oAbility to communicate with staff at all levels in a calm and professional manner
- oAbility to build excellent working relationships
- oAbility to deliver feedback in a positive, constructive manner.
- oAbility to manage challenging behaviour and difficult situations in a diplomatic and professional manner
- oExcellent negotiation skills
- oAbility to communicate with industry sponsors and build relationships while remaining professional and presenting a positive representation of both the East Midlands LCRN and Stakeholders.
- oAbility to persuade and positively influence other team members and work colleagues.
Analytical and Judgement skills
Essential
- oAbility to read, digest and interpret complex documents including European and National legislation, Department of Health policies and guidance, research agreements.
- oAbility to accurately interpret and present data in appropriate formats.
- oAbility to process specialist and complex information and present as appropriate.
- oAbility to absorb information from several sources quickly and be able to make well informed judgements in a timely manner.
- oAbility to learn new information, procedures and processes in a limited time period. E.g. familiarise oneself with a complex study to be able to support researchers or Industry Team at the coordinating centre with tasks that require completing within short deadlines
- oExcellent problem solving skills with the ability to make well informed decisions on a continuous basis.
Skills
Essential
- oSelf-motivated and flexible.
- oEvidence of continued professional development.
- oEvidence of implementing successful and sustainable change.
- oSelf-confidence and ability to cope under pressure.
- oAble to learn new skills and apply these in the workplace.
- oCan work both independently and as part of a team
- oAbility to motivate themselves and others
- oSelf -awareness and understanding of own strengths and limitations and impact of personal style and approach on others
- oCommitment to openness, honesty, inclusiveness and personal integrity in dealing with others
- oCommitment to continuing professional development
- oSets and achieves high standards for own behaviour and personal presentation
Planning and organisation skills
Essential
- oExcellent planning and organisational skills, with the ability to prioritise and work to multiple deadlines
- oRecord of managing work streams/projects simultaneously and delivering to tight deadlines
- oCapacity to formulate short and long term objectives
- oAbility to prioritise and manage own workload and that of others and respond appropriately to deadlines
- oAble to demonstrate the personal development of members within a team
- oAbility to plan and organise a large and varied workload and complete tasks within a tight time frame.
- oDevelopment of key policies and responsibility for keeping them up to date.
- oAbility to work to local and national deadlines, objectives and targets.
- oAbility to work to deadlines when completing study budgets and contract negotiations and other designated time lines
- oAbility to identify and establish agreed workload/tasks with study site teams, Industry sponsors/contract research organisations, CRN and LCRN team members and other NHS organisation contacts
- oAbility to work independently
Equality, Diversity and Inclusion
Essential
- oAble to demonstrate a commitment to and understanding of the importance of treating all individuals with dignity and respect appropriate to their individual needs.
- oAll staff are expected to engage in compassionate and inclusive leadership in the provision of high quality care and interactions with others
Other requirements specific to the role
Essential
- oAbility to travel between the sites in the East Midlands region and nationally as required
- oEngages with and promotes continuous improvement projects
- oWilling to work flexibly across the area
- oWilling to use "hot desking" facilities
- oAbility to use manual handling skills to transport documentation and equipment in a safe manner.
- oAbility to work for long periods on a computer. Use of a keyboard on a daily basis
- oAbility to be able to manage long periods of concentration and pressured work.
Additional information
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).
