Job summary
The Research Governance Coordinator is responsible for a portfolio of studies, which consists of a number of specialties within the Trust. They are the dedicated lead for that portfolio, offering consistent and competent expertise to researchers, clinicians and research delivery team.
Provide a comprehensive managerial and administrative system for the running of research projects in compliance with the UK Policy Framework for Health and Social Care Research, the Human Tissue Act, the Data Protection Act and any other applicable regulatory and government legislation and/or framework and/or guidance.
Review budgets and contracts for commercial and non-commercial research studies. Ensure that the projects are risk assessed before commencement as well as audited.
Monitor studies taking place at the Trust, ensuring that researchers are fully compliant with legislation, policies and guidance.
Main duties of the job
Support the R&D Project Lead in the review process of applications for research Sponsorship and for applications for the Trust to be a participating site for research, identifying any areas that are inconsistent or unclear and communicating with the researcher any changes or further information that is required. The review includes negotiating costings and contracts, particularly for studies from the commercial sector.
Review and analyse research applications to determine whether projects, and therefore the Trust, are compliant with current legislation.
Conduct a full and comprehensive governance assessment for relevant research studies. This involves checking that research staff are appropriately trained/qualified and that facilities are suitable for research etc. This review requires a full understanding of the requirements for research and Ethics review procedures and may involve the post holder visiting the department involved to ensure that research can commence.
Take a leading role on the management of the amendments process, reviewing amendments made to research studies and independently determining if the changes made will affect research governance.
About us
Cambridgeshire and Peterborough NHS Foundation Trust is a health and social care organisation dedicated to providing high-quality care with compassion to improve the health and wellbeing of the people we care for, as well as supporting andempowering them to lead a fulfilling life.
Our clinical teams deliver many NHS services, not only via inpatient and primary care settings, but also within the community. These services include children's, adult and older people's mental health, forensic and specialist mental health, learning disabilities, primary care and liaison psychiatry, substance misuse, social care, research and development.
To achieve our goal, we look to recruit high-calibre candidates who share our vision and values. As an equal opportunities employer, we encourage applications from all sectors of the community, particularly from under-represented groups including people with long term conditions and members of our ethnic minority and LGBTQ+ communities.
Please be advised we reserve the right to close adverts earlier than the closing date should we receive sufficient applications.
Regrettably, we cannot offer sponsorship for all our job roles. If you apply for a role that we cannot offer sponsorship for, unfortunately, your application form will be rejected from the process.
For further information on CPFT, please visit our website at www.cpft.nhs.uk
Job description
Job responsibilities
Please refer to the attached job description and person specification for full details of responsibilities.
With the support of the R&D Project Lead and other R&D staff, provide training to researchers on the research Sponsorship, approval/amendment process, completing the application forms and explaining the requirements of the Research Governance Framework.
Contribute to maintaining and developing Standard Operating Procedures, guidance and procedures for own work area and communicating any changes to those affected by them, which will include external researchers.
To provide regular reports and updates on CPFT R&D study activity and issues that arise for reporting to CPFT strategy groups, NIHR and the Department of Health.
The post holder will be required to keep abreast with new legislation and government requirements relating to research passport process and Trust Research activity reporting to carry out their role. Actively participate in relevant R&D meetings and committees as required.
Job description
Job responsibilities
Please refer to the attached job description and person specification for full details of responsibilities.
With the support of the R&D Project Lead and other R&D staff, provide training to researchers on the research Sponsorship, approval/amendment process, completing the application forms and explaining the requirements of the Research Governance Framework.
Contribute to maintaining and developing Standard Operating Procedures, guidance and procedures for own work area and communicating any changes to those affected by them, which will include external researchers.
To provide regular reports and updates on CPFT R&D study activity and issues that arise for reporting to CPFT strategy groups, NIHR and the Department of Health.
The post holder will be required to keep abreast with new legislation and government requirements relating to research passport process and Trust Research activity reporting to carry out their role. Actively participate in relevant R&D meetings and committees as required.
Person Specification
Education / Qualifications
Essential
- Educated to degree level or equivalent.
- ICH GCP training
Desirable
- Post graduate research qualification.
Experience
Essential
- Experience of working in a research environment (NHS, University, or industry)
- Experience of research set up and/or recruitment practice and processes.
- Experience of information handling and analysis gained in a work environment.
Desirable
- Experience using research databases such as EDGE, CPMS, ODP
- Experience of Sponsor Level Review of Protocol prior to submission for regulatory approvals
- Experience of working in the NHS in a Research Governance capacity
Knowledge & Skills
Essential
- Excellent communication and interpersonal skills
- Excellent IT skills including the recording of data within electronic databases.
- Attention to detail and meticulous organisation and documentation skills.
- Competent in using database. software, such as Excel for analysing and presenting information.
Desirable
- Knowledge of how R&D Finance works within LPMS - EDGE
Personal Qualities
Essential
- Willingness to work flexibly
Person Specification
Education / Qualifications
Essential
- Educated to degree level or equivalent.
- ICH GCP training
Desirable
- Post graduate research qualification.
Experience
Essential
- Experience of working in a research environment (NHS, University, or industry)
- Experience of research set up and/or recruitment practice and processes.
- Experience of information handling and analysis gained in a work environment.
Desirable
- Experience using research databases such as EDGE, CPMS, ODP
- Experience of Sponsor Level Review of Protocol prior to submission for regulatory approvals
- Experience of working in the NHS in a Research Governance capacity
Knowledge & Skills
Essential
- Excellent communication and interpersonal skills
- Excellent IT skills including the recording of data within electronic databases.
- Attention to detail and meticulous organisation and documentation skills.
- Competent in using database. software, such as Excel for analysing and presenting information.
Desirable
- Knowledge of how R&D Finance works within LPMS - EDGE
Personal Qualities
Essential
- Willingness to work flexibly
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).
