Job summary
Responsible for developing, promoting, facilitating, and advising on, high quality research activity throughout our Trust, an exciting opportunity has arising for a Research Manager to lead a team that enables the Trust to undertake research as a core clinical activity. The Research Manager will compile a Chair's Report following monthly Research Meetings to present to the Digital,Education, Research, Innovation & Commercialisation Committee.
Applicants must hold a degree in a relevant health or science subject (or equivalent) and attained a postgraduate qualification within clinical research (Bsc or equivalent). You will also have worked within clinical research environment within either a commercial or academic organisation.
This is a full time permanent post.
**Banding subject to agenda for change evaluation**
Main duties of the job
The post holder will ensure that systems are in place to ensure accurate and timely research project notification and approval and that such projects meet all the necessary research governance and regulatory requirements required for the Trust to either sponsor or host them. Liaising with finance and research team colleagues will ensure that projects are accurately staffed and costed. The post holder will also be responsible for the management of the department's information systems including the Research database, the Research Passport Database and CSP. The post holder will support and provide advice to researchers pre-award and will be responsible for all aspects of disseminating information to researchers via the internet/intranet, newsletters and forums. The post holder will also act as a main contact for the WMN CLRN for dissemination of information to the Trust as well as ensuring that all possible financial support is negotiated and requested from WMN CLRN. The post holder will work with the Finance Lead and the Chief Medical Officer & Research Director in the development and completion of the yearly Research Business Case for the Trust for both internal and external purposes and for the WMN CLRN.
About us
The Robert Jones and Agnes Hunt Orthopaedic NHS Trust (RJAH)is one of the leading orthopaedic hospitals in the country, with some of the highest levels of staff and patient satisfaction, as well as a strong reputation for research and innovation.
Joining RJAH is more than just a job - we want our people to have the best opportunities to thrive in their role.We have a range of fantastic staff benefits on offer to everyone who joins RJAH and you'll have access to outstanding professional development opportunities and state-of-the-art facilities - including our recently-opened £6 million Headley Court Veterans' Orthopaedic Centre (the first unit of its kind in the UK).RJAH has strong links with a range of universities including Staffordshire, Keele, Chester and Birmingham.
As the busiest orthopaedic centre in the UK, we have a portfolio of sponsored and hosted studies covering all aspects of musculoskeletal care. The Research Office has a tight knit team of Project Managers, Clinicians and Governance Support who ensure that the research undertaken by the Trust is safe and of high quality.
Job description
Job responsibilities
- The post holder is required to communicate and collaborate with a number of key stakeholders within the research community in the UK and abroad. It will include communicating highly complex and highly sensitive and contentious information.
- A working knowledge of the conduct and management of research in primary and secondary care is also a requirement of this post together with experience of preparing strategies, policies and Board level reports.
- Develop and implement strategies and systems for quality assurance. These should include systems which:
- Ensure that all research within RJAH is managed in accordance with the requirements of the Research Governance Framework for Health and Social Care (2001) and subsequent versions, the Medicines for Human Use (Clinical Trials) Regulations (SI 1031/2004 and later amendments) and other relevant regulations and guidelines such as GCP. The Governance staff within the Innovation Team are dedicated to supporting Research and Clinical Audit across both areas and will work closely with the Research Manager.
- Ensure processes and Standard Operating Procedures (SOPs) are in place to set up studies within RJAH to comply with ethical, regulatory and relevant Research guidance, assisting with complex queries as necessary.
- Ensure RJAH signatory in place for confidentiality agreements between RJAH and other organisations including pharmaceutical and medical device companies in relation to research activity & intellectual property
- Responsible for reviewing clinical trial agreements both commercial and non commercial on behalf of the Chief Medical Officer, Research Director and or Chief Executive and advising accordingly.
- Promote joint working with medical and other healthcare professionals within Research both internally and nationally.
- Work with the Medical and Research Director to facilitate the development, implementation and maintenance of RJAH Policies, Procedures and Strategy for Research across the whole organisation. These are complex documents that have a long term impact on the whole organisation.
- Oversee the management and maintenance of the databases of Research activities (e.g. EDGE, WMN CLRN Activity Log)
- Support all researchers and potential researchers by providing advice, information and training on the processes involved in undertaking Research.
- Ensure that all aspects relating to quality, ethics and risk management are adhered to for all areas of RJAH Research activity and that there are systems in place for monitoring such activity and reducing the associated research risks to the whole Organisation.
- Co-ordinate RJAH Research Risk Review Group, Research Meeting.
- Assist in the preparation / preparation of detailed and complex reports as required, to include the Research Annual Report to the WMN CLRN. This includes data collection, compilation of data and writing of report (author), the content of which can impact on the financial support received from the central agency and therefore the Research agenda and strategy across the whole organisation.
- To represent and deputise for the Chief Medical Officer & Research Director as appropriate.
- Continue to develop the process for the management and monitoring of all Research activities within RJAH by responding to changing National and organisational needs.
- Organise training on Research related topics e.g. good clinical practice.
- Support the Chief Medical Officer & Research Director in the development and implementation of research practice standards in support of research.
- Contribute to the planning and management of an annual Research Conference/Day to disseminate the activity and results of RJAH research.
- Collaborate with Research leads in each research active division of RJAH to ensure the growth of research and the development of appropriate and often complex systems to assure quality in system flows for Research approval and ethical site-specific assessments.
- Key role in the review of the process for the management and monitoring of all Research and Development activities within RJAH in line with Research Governance Framework for Health and Social Care (2001) and subsequent versions, the Medicines for Human Use (Clinical Trials) Regulations (SI 1031/2004 and later amendments) and other relevant regulations and guidelines, proposing, developing and leading the implementation of changes that will impact on other areas within the organisation.
- Ensuring RJAH remains at the forefront of service delivery nationally, advising the Chief Medical Officer & Research Director of new NIHR / Government service delivery initiatives within Research.
- Identify and advise the Chief Medical Officer & Research Director of new National Research related service delivery tendering opportunities.
- The development, co-ordination and ongoing management of the Research approval process, including ensuring that all projects have an identified Sponsor and are registered, reviewed and approved to ensure indemnity in line with the NHS Indemnity scheme or Commercial / Academic Indemnity Insurance. Also that the required documentation is completed including the development and monitoring of appropriate formal research agreements with other organisations which collaborate with RJAH, proposing, developing and leading the implementation of changes that will impact on other areas within the organisation.
- The development and implementation of joint processes for the management of research across RJAH and the promotion of links with other NHS organisations (and other healthcare and research providers), to promote an integrated approach to research management.
- RJAH lead for Research, and ensure that the principles and requirements of the research governance framework are consistently applied across all Divisions in relation to Research
- Contribute to the Trusts programmes of development and innovation
- Oversee the development, promotion and implementation of the Research philosophy at a strategic level in collaboration with the Chief Medical Officer & Research Director. This will have an impact across all areas of the organisation.
- Report preparation for submission at Board and WMN CLRN level
- Promoting communication of Research issues and opportunities to the researchers across RJAH, including the development and management of the Research Departments website.
- Advising and supporting RJAH researchers, proactively leading initiatives to maintain and improve the quality of the research environment (including facilitating the provision of statistical support and other infrastructure needs) and the development of RJAH research-active workforce.
- To identify, protect, manage, support and exploit intellectual property related to Research activity throughout RJAH and which can impact on all areas across the organisation, when I.P. is identified.
- Promoting RJAH capability to external organisations and partners such as CLRN and Pharmaceutical and Medical Devices companies.
- The Research Department is responsible for accounting for the NIHR CLRN Research Support funding allocated to RJAH by WMN CLRN.
- The post-holder will play a leading role in meeting the annual reporting requirements which secures this funding stream and in meeting the future challenges posed by the NIHR CLRN funding allocation process.
- Jointly with RJAH finance department, develop and implement processes to ensure the full costing of research projects and to maximise recovery of costs from external funders.
- Identify and circulate information on Research funding opportunities to RJAH research active professionals.
- Responsible for recruiting members of staff to the department.
- To take responsibility for managing any grievance and disciplinary matters etc in partnership with the Trusts HR Department in line with RJAH policies and procedures.
- Develop skills and capacity of divisional research leads to enable the development of internal Research management systems for reviewing local risk and resource issues relating to individual project level.
- To oversee the management of the Research Management database (EDGE) which records all RJAH research activity. This information is reported to the Board via the Chief Medical Officer & Research Director.
- Maintain RJAH own systems and the NIHR CSP system for recording and reporting Research approvals within RJAH and to external organisations.
- Advise on the electronic processes, the integrated application system (IRAS) for gaining ethical and Research approval and especially on the NIHR CSP system.
- Coordinate and sustain the Research approval process for reviewing and approving research studies within RJAH.
- Maintain and develop appropriate systems for registering and scrutinising Research applications to ensure their compliance with the Research Governance Framework and for monitoring same.
- Advise researchers and research partners on the format of partnership, contractual and/or indemnity agreements, monitor performance and progress against such agreements.
- Ensure research activity is audited on a regular basis to confirm compliance to the Research Governance Framework for Health and Social Care (2001) and subsequent versions, the Medicines for Human Use (Clinical Trials) Regulations (SI 1031/2004 and later amendments) and other relevant regulations and guidelines.
- RJAH lead on all research governance matters, supporting the Chief Medical Officer & Research Director in advising the Chief Executive and Board directly.
- The information requested below is for supplementary purposes, to support an accurate job matching outcome, by clearly identifying the post holders exposure to certain conditions whilst undertaking the job role
- ** Please refer to attachment for full job description**
Job description
Job responsibilities
- The post holder is required to communicate and collaborate with a number of key stakeholders within the research community in the UK and abroad. It will include communicating highly complex and highly sensitive and contentious information.
- A working knowledge of the conduct and management of research in primary and secondary care is also a requirement of this post together with experience of preparing strategies, policies and Board level reports.
- Develop and implement strategies and systems for quality assurance. These should include systems which:
- Ensure that all research within RJAH is managed in accordance with the requirements of the Research Governance Framework for Health and Social Care (2001) and subsequent versions, the Medicines for Human Use (Clinical Trials) Regulations (SI 1031/2004 and later amendments) and other relevant regulations and guidelines such as GCP. The Governance staff within the Innovation Team are dedicated to supporting Research and Clinical Audit across both areas and will work closely with the Research Manager.
- Ensure processes and Standard Operating Procedures (SOPs) are in place to set up studies within RJAH to comply with ethical, regulatory and relevant Research guidance, assisting with complex queries as necessary.
- Ensure RJAH signatory in place for confidentiality agreements between RJAH and other organisations including pharmaceutical and medical device companies in relation to research activity & intellectual property
- Responsible for reviewing clinical trial agreements both commercial and non commercial on behalf of the Chief Medical Officer, Research Director and or Chief Executive and advising accordingly.
- Promote joint working with medical and other healthcare professionals within Research both internally and nationally.
- Work with the Medical and Research Director to facilitate the development, implementation and maintenance of RJAH Policies, Procedures and Strategy for Research across the whole organisation. These are complex documents that have a long term impact on the whole organisation.
- Oversee the management and maintenance of the databases of Research activities (e.g. EDGE, WMN CLRN Activity Log)
- Support all researchers and potential researchers by providing advice, information and training on the processes involved in undertaking Research.
- Ensure that all aspects relating to quality, ethics and risk management are adhered to for all areas of RJAH Research activity and that there are systems in place for monitoring such activity and reducing the associated research risks to the whole Organisation.
- Co-ordinate RJAH Research Risk Review Group, Research Meeting.
- Assist in the preparation / preparation of detailed and complex reports as required, to include the Research Annual Report to the WMN CLRN. This includes data collection, compilation of data and writing of report (author), the content of which can impact on the financial support received from the central agency and therefore the Research agenda and strategy across the whole organisation.
- To represent and deputise for the Chief Medical Officer & Research Director as appropriate.
- Continue to develop the process for the management and monitoring of all Research activities within RJAH by responding to changing National and organisational needs.
- Organise training on Research related topics e.g. good clinical practice.
- Support the Chief Medical Officer & Research Director in the development and implementation of research practice standards in support of research.
- Contribute to the planning and management of an annual Research Conference/Day to disseminate the activity and results of RJAH research.
- Collaborate with Research leads in each research active division of RJAH to ensure the growth of research and the development of appropriate and often complex systems to assure quality in system flows for Research approval and ethical site-specific assessments.
- Key role in the review of the process for the management and monitoring of all Research and Development activities within RJAH in line with Research Governance Framework for Health and Social Care (2001) and subsequent versions, the Medicines for Human Use (Clinical Trials) Regulations (SI 1031/2004 and later amendments) and other relevant regulations and guidelines, proposing, developing and leading the implementation of changes that will impact on other areas within the organisation.
- Ensuring RJAH remains at the forefront of service delivery nationally, advising the Chief Medical Officer & Research Director of new NIHR / Government service delivery initiatives within Research.
- Identify and advise the Chief Medical Officer & Research Director of new National Research related service delivery tendering opportunities.
- The development, co-ordination and ongoing management of the Research approval process, including ensuring that all projects have an identified Sponsor and are registered, reviewed and approved to ensure indemnity in line with the NHS Indemnity scheme or Commercial / Academic Indemnity Insurance. Also that the required documentation is completed including the development and monitoring of appropriate formal research agreements with other organisations which collaborate with RJAH, proposing, developing and leading the implementation of changes that will impact on other areas within the organisation.
- The development and implementation of joint processes for the management of research across RJAH and the promotion of links with other NHS organisations (and other healthcare and research providers), to promote an integrated approach to research management.
- RJAH lead for Research, and ensure that the principles and requirements of the research governance framework are consistently applied across all Divisions in relation to Research
- Contribute to the Trusts programmes of development and innovation
- Oversee the development, promotion and implementation of the Research philosophy at a strategic level in collaboration with the Chief Medical Officer & Research Director. This will have an impact across all areas of the organisation.
- Report preparation for submission at Board and WMN CLRN level
- Promoting communication of Research issues and opportunities to the researchers across RJAH, including the development and management of the Research Departments website.
- Advising and supporting RJAH researchers, proactively leading initiatives to maintain and improve the quality of the research environment (including facilitating the provision of statistical support and other infrastructure needs) and the development of RJAH research-active workforce.
- To identify, protect, manage, support and exploit intellectual property related to Research activity throughout RJAH and which can impact on all areas across the organisation, when I.P. is identified.
- Promoting RJAH capability to external organisations and partners such as CLRN and Pharmaceutical and Medical Devices companies.
- The Research Department is responsible for accounting for the NIHR CLRN Research Support funding allocated to RJAH by WMN CLRN.
- The post-holder will play a leading role in meeting the annual reporting requirements which secures this funding stream and in meeting the future challenges posed by the NIHR CLRN funding allocation process.
- Jointly with RJAH finance department, develop and implement processes to ensure the full costing of research projects and to maximise recovery of costs from external funders.
- Identify and circulate information on Research funding opportunities to RJAH research active professionals.
- Responsible for recruiting members of staff to the department.
- To take responsibility for managing any grievance and disciplinary matters etc in partnership with the Trusts HR Department in line with RJAH policies and procedures.
- Develop skills and capacity of divisional research leads to enable the development of internal Research management systems for reviewing local risk and resource issues relating to individual project level.
- To oversee the management of the Research Management database (EDGE) which records all RJAH research activity. This information is reported to the Board via the Chief Medical Officer & Research Director.
- Maintain RJAH own systems and the NIHR CSP system for recording and reporting Research approvals within RJAH and to external organisations.
- Advise on the electronic processes, the integrated application system (IRAS) for gaining ethical and Research approval and especially on the NIHR CSP system.
- Coordinate and sustain the Research approval process for reviewing and approving research studies within RJAH.
- Maintain and develop appropriate systems for registering and scrutinising Research applications to ensure their compliance with the Research Governance Framework and for monitoring same.
- Advise researchers and research partners on the format of partnership, contractual and/or indemnity agreements, monitor performance and progress against such agreements.
- Ensure research activity is audited on a regular basis to confirm compliance to the Research Governance Framework for Health and Social Care (2001) and subsequent versions, the Medicines for Human Use (Clinical Trials) Regulations (SI 1031/2004 and later amendments) and other relevant regulations and guidelines.
- RJAH lead on all research governance matters, supporting the Chief Medical Officer & Research Director in advising the Chief Executive and Board directly.
- The information requested below is for supplementary purposes, to support an accurate job matching outcome, by clearly identifying the post holders exposure to certain conditions whilst undertaking the job role
- ** Please refer to attachment for full job description**
Person Specification
Qualification and Training
Essential
- Degree (or equivalent) in relevant health/science subject.
- Postgraduate qualification (BSc or equivalent) in relevant subject.
Desirable
- Masters or PhD
- Recent completion of Good Clinical Practice (GCP) course
Experience
Essential
- Clinical Research in commercial or academic organisation.
Desirable
- Commercial clinical research experience either as a CRA, project manager or site co-ordinator.
- Experience of grant writing and the NIHR system.
Skills / Comptencies
Essential
- Able to advise on clinical research projects, including correct completion of research related documentation.
- Able to develop trial protocols, and other study documents.
- Proficient Microsoft Office user.
- Able to work on own initiative, under pressure and as part of a multi-disciplinary team.
- Effective communication skills - written, verbal and digital.
- Ability to support and develop a multidisciplinary team of Research Office clinicians, programme managers and support staff.
Desirable
- Appraisal and interviewing skills
- Able to present work to a wide range of audiences.
- Experience of report writing.
Knowledge
Essential
- GCP, NRES, IRAS, MHRA
- Regulatory and governance requirements of clinical research.
- NHS Research Strategy, Research Governance Framework.
Desirable
- Understands the development of clinical research within the NHS
- Understands NIHR funding system.
- Understands CLRN and funding provided
Person Specification
Qualification and Training
Essential
- Degree (or equivalent) in relevant health/science subject.
- Postgraduate qualification (BSc or equivalent) in relevant subject.
Desirable
- Masters or PhD
- Recent completion of Good Clinical Practice (GCP) course
Experience
Essential
- Clinical Research in commercial or academic organisation.
Desirable
- Commercial clinical research experience either as a CRA, project manager or site co-ordinator.
- Experience of grant writing and the NIHR system.
Skills / Comptencies
Essential
- Able to advise on clinical research projects, including correct completion of research related documentation.
- Able to develop trial protocols, and other study documents.
- Proficient Microsoft Office user.
- Able to work on own initiative, under pressure and as part of a multi-disciplinary team.
- Effective communication skills - written, verbal and digital.
- Ability to support and develop a multidisciplinary team of Research Office clinicians, programme managers and support staff.
Desirable
- Appraisal and interviewing skills
- Able to present work to a wide range of audiences.
- Experience of report writing.
Knowledge
Essential
- GCP, NRES, IRAS, MHRA
- Regulatory and governance requirements of clinical research.
- NHS Research Strategy, Research Governance Framework.
Desirable
- Understands the development of clinical research within the NHS
- Understands NIHR funding system.
- Understands CLRN and funding provided
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.
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).
Additional information
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.
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
Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Address
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Trust
Oswestry
SY10 7AG
Employer's website
https://www.rjah.nhs.uk/ (Opens in a new tab)
