Job summary
We are looking for someone with experience, who is ready to be committed to provide support to clinical research within our Trust. We're looking for candidates who are open minded and flexible in their approach, who understand that proportionate research management is essential in supporting busy clinicians and clinical academics.
The post-holder works as part of the Research and Innovation Centre team responsible for implementation and maintenance systems to deliver a productive research atmosphere to facilitate the delivery of the Trust research objectives. The successful candidate will also be interested expanding our research portfolio by supporting innovative external funding applications.
The post holder should know about current clinical research environment within the NHS, be knowledgeable about GCP, HRA processes, CRN processes and potentially be familiar with grant funding environment.
Main duties of the job
The post-holder works as part of the Research and Innovation Centre team responsible for implementation and maintenance systems to deliver productive research atmosphere, which enables the delivery of Trust objectives.
The post-holder will be required to deliver and maintain the research support functions for the RNOH as required by the Health Research Authority (HRA).
The RNOH RIC team expects all staff to have a positive, pragmatic and proportionate approach to interpretation of UK Policy Framework for Health and Social Care Research and relevant legal requirements and guidance.
About us
Royal National Orthopaedic Hospital NHS Trust is a leading organisation, specialising in orthopaedic, musculoskeletal and spinal injury research and rehabilitation.
Our aim is to develop research supportive environment, which encourages good quality research, which can improve patient care and bring innovation and excellence to our patients. The post-holder will play a key role in delivering our aims.
Job description
Job responsibilities
Main Duties and Responsibilities
The post-holder will be working closely with various investigators with clinical units, project leads, research nurses, research physiotherapists, research coordinators, trial managers, sponsors and academic staff.
The post holder will be providing line management responsibilities for the RMG officer.
Research Management and Governance
- Actively involved in the delivery of the overarching Research Management and Governance Function of Research and Innovation Centre
- Responsible for ensuring investigators, academic collaborators, clinical research fellows, nurses, support departments, external organisations receive professional regulatory and governance advice, guidance and support, which is proportionate to their activities.
- Working knowledge of the regulatory and ethics requirements for the conduct of clinical research, especially the Research Governance Framework, Good Clinical Practice, and related guidance, in order to ensure delivery of authoritative advice to investigators and continued compliance with regulations and governance.
- Able to work with minimum supervision, line management responsibilities and provide guidance and support to junior members of the team on the RMG function.
- To maintain a strong and current working knowledge of developments regarding clinical research management, regulation and governance, and NHS structure and services.
- Lead on reviewing research ethics submissions and other regulatory bodies, and ensure the protocols and other study documentation in line with Trust SOPs and Research Governance Framework.
- Conduct pre-study feasibility, review protocols for feasibility and make sure relevant logistical requirements are covered to ensure the success of a clinical study in accordance with regulatory approved conditions.
- Maintains a working knowledge of non-commercial research processed and documentation e.g. attributing costs for health and social care Research and Development (AcoRD) and SOECAT and support RIC finance coordinator with AcoRD and SOECAT related tasks.
- Support with the set-up of studies, negotiations and finalisation of all that pertains to studies on site.
- Involved with local implementation of national and local strategies related to research.
- Support costing of commercial as well as non-commercial project.
- A grounding and understanding of medical device directives and their application in studies
- Good working relationship with a range of stakeholders, including clinicians, academics, our local NIHR network, commercial companies and relevant departments within the Trust.
- Has clear understanding of governance management systems e.g. CPMS, Edge, and ensures accurate information is entered and can produce reports.
- To ensure studies have received applicable regulatory approvals and staff are appropriately trained and follows a structured approach to confirmation of capacity and capability and issuing of greenlight before a study commences.
- Promote ethos of research within the clinical units and provide the facilitation required to deliver research
- Has clear understanding of the Human Tissue Act, provides guidance to researchers and works closely with the Designated Individual, Persons Designated and the Biobank Manager. Has oversight of RNOH paper work and adherence to SOPs.
- Attend meetings on behalf of the RMG team, chairs relevant meetings and ensures accurate minutes are taken and actively involved in the running of the Project Evaluation Panel.
- With support from the Research Projects Delivery Lead, identify suitable funding opportunities for RNOH led projects and support the coordination of grant submissions.
- Support the day to day activities of R&D Office and any other relevant duties, which will be required from time to time for efficient running of the department
Job description
Job responsibilities
Main Duties and Responsibilities
The post-holder will be working closely with various investigators with clinical units, project leads, research nurses, research physiotherapists, research coordinators, trial managers, sponsors and academic staff.
The post holder will be providing line management responsibilities for the RMG officer.
Research Management and Governance
- Actively involved in the delivery of the overarching Research Management and Governance Function of Research and Innovation Centre
- Responsible for ensuring investigators, academic collaborators, clinical research fellows, nurses, support departments, external organisations receive professional regulatory and governance advice, guidance and support, which is proportionate to their activities.
- Working knowledge of the regulatory and ethics requirements for the conduct of clinical research, especially the Research Governance Framework, Good Clinical Practice, and related guidance, in order to ensure delivery of authoritative advice to investigators and continued compliance with regulations and governance.
- Able to work with minimum supervision, line management responsibilities and provide guidance and support to junior members of the team on the RMG function.
- To maintain a strong and current working knowledge of developments regarding clinical research management, regulation and governance, and NHS structure and services.
- Lead on reviewing research ethics submissions and other regulatory bodies, and ensure the protocols and other study documentation in line with Trust SOPs and Research Governance Framework.
- Conduct pre-study feasibility, review protocols for feasibility and make sure relevant logistical requirements are covered to ensure the success of a clinical study in accordance with regulatory approved conditions.
- Maintains a working knowledge of non-commercial research processed and documentation e.g. attributing costs for health and social care Research and Development (AcoRD) and SOECAT and support RIC finance coordinator with AcoRD and SOECAT related tasks.
- Support with the set-up of studies, negotiations and finalisation of all that pertains to studies on site.
- Involved with local implementation of national and local strategies related to research.
- Support costing of commercial as well as non-commercial project.
- A grounding and understanding of medical device directives and their application in studies
- Good working relationship with a range of stakeholders, including clinicians, academics, our local NIHR network, commercial companies and relevant departments within the Trust.
- Has clear understanding of governance management systems e.g. CPMS, Edge, and ensures accurate information is entered and can produce reports.
- To ensure studies have received applicable regulatory approvals and staff are appropriately trained and follows a structured approach to confirmation of capacity and capability and issuing of greenlight before a study commences.
- Promote ethos of research within the clinical units and provide the facilitation required to deliver research
- Has clear understanding of the Human Tissue Act, provides guidance to researchers and works closely with the Designated Individual, Persons Designated and the Biobank Manager. Has oversight of RNOH paper work and adherence to SOPs.
- Attend meetings on behalf of the RMG team, chairs relevant meetings and ensures accurate minutes are taken and actively involved in the running of the Project Evaluation Panel.
- With support from the Research Projects Delivery Lead, identify suitable funding opportunities for RNOH led projects and support the coordination of grant submissions.
- Support the day to day activities of R&D Office and any other relevant duties, which will be required from time to time for efficient running of the department
Person Specification
Knowledge, Training and Experience
Essential
- Educated to degree level
- GCP Training
- Human Tissue Act
- Six year's experience in a healthcare or academic environment
- Evidence of working with staff from different professional disciplines
Desirable
- Educated to a Master's Degree level
- Science based degree
- Experience of working with academics
Responsibility for R&D
Essential
- Knowledge of Research Governance Framework
- Good research process knowledge
- Good understanding of ethics process and using IRAS
- Good understanding of device regulations and other applicable legal requirements related to a range of Orthopaedic studies
- Demonstrates and understanding of current developments in the Trust, NHS and Government strategies
- Good knowledge of clinical research environment in England (i.e. NIHR, HRA, MHRA)
Desirable
- Knowledge of ICH GCP and EU clinical trials directive and medicines for human use regulations
Other skills
Essential
- Costing studies
- Experience in interpreting national guidance and policies and their interpretation at a local level
- Good computer skills
- Good organisational skills and self-motivated
Person Specification
Knowledge, Training and Experience
Essential
- Educated to degree level
- GCP Training
- Human Tissue Act
- Six year's experience in a healthcare or academic environment
- Evidence of working with staff from different professional disciplines
Desirable
- Educated to a Master's Degree level
- Science based degree
- Experience of working with academics
Responsibility for R&D
Essential
- Knowledge of Research Governance Framework
- Good research process knowledge
- Good understanding of ethics process and using IRAS
- Good understanding of device regulations and other applicable legal requirements related to a range of Orthopaedic studies
- Demonstrates and understanding of current developments in the Trust, NHS and Government strategies
- Good knowledge of clinical research environment in England (i.e. NIHR, HRA, MHRA)
Desirable
- Knowledge of ICH GCP and EU clinical trials directive and medicines for human use regulations
Other skills
Essential
- Costing studies
- Experience in interpreting national guidance and policies and their interpretation at a local level
- Good computer skills
- Good organisational skills and self-motivated
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).
