Frimley Health NHS Foundation Trust

Research and Innovation Governance Officer

The closing date is 11 December 2025

Job summary

An exciting opportunity has arisen within our R&I Team for a research professional who has experience in clinical study governance and expertise within the regulatory environment surrounding clinical studies.

The post holder will be expected to undertake duties in an independent manner without the need for direct supervision and be capable of using and taking initiative. The role requires a research professional who has experience in clinical study governance and expertise within the regulatory environment surrounding clinical studies.

The post holder will be working cross-site within the Trust.

Main duties of the job

The primary responsibility of the R&I Governance Officer is to co-ordinate the R&I governance approval process, ensuring that correct documents are available for Trust approval, keep up to date records on EDGE research management system, EPIC and other database systems, as required.

The post holder will be responsible for ensuring that appropriate governance arrangements are in place and maintained in accordance with the national and international legislation and guidance (e.g. UK Policy Framework for Health and Social Care Research, International Conference on Harmonisation Guidelines- Good Clinical Practice (ICH-GCP) through the conduct of the research across all sites within the Trust.

The post holder supports the Head of R&I in audit and monitoring processes, collates and presents information required for internal and external reports and other activities as required to promote and ensure safe delivery of R&I within the Trust.

The post holder will be expected to undertake duties in an independent manner without the need for direct supervision and be capable of using and taking initiative.

The role requires a research professional who has experience in clinical study governance and expertise within the regulatory environment surrounding clinical studies.

About us

Frimley Health NHS Foundation Trust is committed to being an inclusive and disability confident employer and has been awarded the Gold for the Armed Forces Employment Recognition Scheme. We provide first class development opportunities for all staff and have a wide range of professional, management and leadership, and clinical skills training available.

Here at Frimley Health NHS Foundation Trust, we know how important it is to have a healthy work life balance; this benefits not only individuals but the patients we care for too.

We encourage applications from people who wish to work on a flexible basis, recognising that flexibility may mean a range of different working patterns and hours, we do our utmost to work with our staff to meet their needs and the needs of our service and its users.

Frimley Health Trust benefits on Vimeo

Details

Date posted

28 November 2025

Pay scheme

Agenda for change

Band

Band 6

Salary

£40,617 to £48,778 a year per annum incl HCAS

Contract

Fixed term

Duration

2 years

Working pattern

Full-time

Reference number

151-KM104

Job locations

Wexham Park Hospital

Wexham Street

Slough

SL2 4HL


Job description

Job responsibilities

To act as an expert resource and is responsible for ensuring all elements ofstudy set up are completed in accordance with UK and EU legal requirements,

Ensure all studies have the required documentation and arrangements in place prior to providing R&I approval confirming the Trusts readiness to recruit.

Manage the potentially conflicting demands of governance approval of the capacity and capability (R&I approval) of multiple research projects in collaboration with the research delivery team and Research Operations Manager.

Oversee a register of ICH-GCP training and Research-CVs for all research staff

Establish, evaluate and update existing Trust policies and Standard Operating Procedures (SOPs) including the development of new local polices and SOPs in accordance with national legislation for research and recommendations from regulatory authorities such as Health Research Authority (HRA) and Medicines and Healthcare products Regulatory Agency (MHRA).

Ensure the implementation of research Standard Operating Procedures across the Trust in conjunction with the SOP Controller.

To keep all staff informed of any regulatory changes and its impact on the local research processes including sponsorship processes.

Collaborate with the R&I governance staff in contract negotiations. Ensure study protocol amendments are incorporated into research practice in a timely manner and any delay/hindrance in the enactment of the amendment, is brought to the attention of the study sponsor at the earliest and before the deadline.

Prepare, conduct and oversee the internal audit process of the department under the guidance of Head of R&I.Prepare, support and coordinate external regulatory inspections including responses to findings and implementation of subsequent action plans in liaison with Research Operations Manager.

Support the Chief Investigator (CI) in obtaining ethical permissions, including completing IRAS / MHRA, local ethics and HRA submissions and support the process for Trust sponsored studies.

As directed by Head of R&I, ensure regular invoicing in line with contractual agreements, in a timely manner and provide study finance support to raise timely invoices in line with contractual agreements and to ensure accurate records are maintained for finance associated with studies.

Assist in negotiation / co-ordination of costing information and development of systems (e.g. EDGE finance workflows and forms) to track / forecast potential costs.

Ensure costs are assigned to the appropriate budgets according to current R&I finance policiesAnalyse, investigate and resolve study income queries including liaising with the finance department.

Contribute to the development and validation of systems e.g. electronic data capture platforms, in the R&I department to provide effective support in the set-up and delivery of research and innovation.

Support the development of home-grown studies and grant applications, including IRAS submission.

Contribute to the professional and educational development of staff by identifying and facilitating training opportunities in conjunction with Research Training lead, where appropriate.

Ensure the archiving of study related documentation in line with the Trial Agreement and ICH-GCP / ISO 14155 / Trust and departmental Archiving and Off-Site Polices.

Contribute to the creation and maintenance of content on the R&I website and intranet pages ensuring information provided is accurate and up to date

Assist in the development of marketing material to promote FHFTs research and innovation and to improve engagement of staff, patients and public in it.

Support R&I team to promote research at FHFT to internal and external stakeholders through events and training.

Assist in Patient, Public, Involvement and Engagement (PPIE) activities of R&I.

Job description

Job responsibilities

To act as an expert resource and is responsible for ensuring all elements ofstudy set up are completed in accordance with UK and EU legal requirements,

Ensure all studies have the required documentation and arrangements in place prior to providing R&I approval confirming the Trusts readiness to recruit.

Manage the potentially conflicting demands of governance approval of the capacity and capability (R&I approval) of multiple research projects in collaboration with the research delivery team and Research Operations Manager.

Oversee a register of ICH-GCP training and Research-CVs for all research staff

Establish, evaluate and update existing Trust policies and Standard Operating Procedures (SOPs) including the development of new local polices and SOPs in accordance with national legislation for research and recommendations from regulatory authorities such as Health Research Authority (HRA) and Medicines and Healthcare products Regulatory Agency (MHRA).

Ensure the implementation of research Standard Operating Procedures across the Trust in conjunction with the SOP Controller.

To keep all staff informed of any regulatory changes and its impact on the local research processes including sponsorship processes.

Collaborate with the R&I governance staff in contract negotiations. Ensure study protocol amendments are incorporated into research practice in a timely manner and any delay/hindrance in the enactment of the amendment, is brought to the attention of the study sponsor at the earliest and before the deadline.

Prepare, conduct and oversee the internal audit process of the department under the guidance of Head of R&I.Prepare, support and coordinate external regulatory inspections including responses to findings and implementation of subsequent action plans in liaison with Research Operations Manager.

Support the Chief Investigator (CI) in obtaining ethical permissions, including completing IRAS / MHRA, local ethics and HRA submissions and support the process for Trust sponsored studies.

As directed by Head of R&I, ensure regular invoicing in line with contractual agreements, in a timely manner and provide study finance support to raise timely invoices in line with contractual agreements and to ensure accurate records are maintained for finance associated with studies.

Assist in negotiation / co-ordination of costing information and development of systems (e.g. EDGE finance workflows and forms) to track / forecast potential costs.

Ensure costs are assigned to the appropriate budgets according to current R&I finance policiesAnalyse, investigate and resolve study income queries including liaising with the finance department.

Contribute to the development and validation of systems e.g. electronic data capture platforms, in the R&I department to provide effective support in the set-up and delivery of research and innovation.

Support the development of home-grown studies and grant applications, including IRAS submission.

Contribute to the professional and educational development of staff by identifying and facilitating training opportunities in conjunction with Research Training lead, where appropriate.

Ensure the archiving of study related documentation in line with the Trial Agreement and ICH-GCP / ISO 14155 / Trust and departmental Archiving and Off-Site Polices.

Contribute to the creation and maintenance of content on the R&I website and intranet pages ensuring information provided is accurate and up to date

Assist in the development of marketing material to promote FHFTs research and innovation and to improve engagement of staff, patients and public in it.

Support R&I team to promote research at FHFT to internal and external stakeholders through events and training.

Assist in Patient, Public, Involvement and Engagement (PPIE) activities of R&I.

Person Specification

Qualifications

Essential

  • Degree level or equivalent professional experience in research environment
  • Significant experience of working in a clinical research environment
  • Experience in audit and monitoring of research studies in compliance with ICH-GCP

Desirable

  • Good Clinical Practice Certificate

Experience

Essential

  • Experience research of working in the NHS
  • At least 2 years' experience of the Health Research Authority process for granting research approval in the NHS.
  • Experience in the use of the EDGE research management platform

Desirable

  • Experience of submitting external grant applications
  • Awareness of Trust Sponsorship processes

Skill and Knowledge

Essential

  • Possess highly developed, specialist knowledge related to research activity and research governance
  • Understanding of UK Policy Framework for Health and Social Care Research and current issues in the NHS
  • Knowledge of NIHR High Level objectives and priorities
  • IT skills particularly in the use of MS Office applications
Person Specification

Qualifications

Essential

  • Degree level or equivalent professional experience in research environment
  • Significant experience of working in a clinical research environment
  • Experience in audit and monitoring of research studies in compliance with ICH-GCP

Desirable

  • Good Clinical Practice Certificate

Experience

Essential

  • Experience research of working in the NHS
  • At least 2 years' experience of the Health Research Authority process for granting research approval in the NHS.
  • Experience in the use of the EDGE research management platform

Desirable

  • Experience of submitting external grant applications
  • Awareness of Trust Sponsorship processes

Skill and Knowledge

Essential

  • Possess highly developed, specialist knowledge related to research activity and research governance
  • Understanding of UK Policy Framework for Health and Social Care Research and current issues in the NHS
  • Knowledge of NIHR High Level objectives and priorities
  • IT skills particularly in the use of MS Office applications

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.

Employer details

Employer name

Frimley Health NHS Foundation Trust

Address

Wexham Park Hospital

Wexham Street

Slough

SL2 4HL


Employer's website

https://www.fhft.nhs.uk/ (Opens in a new tab)


Employer details

Employer name

Frimley Health NHS Foundation Trust

Address

Wexham Park Hospital

Wexham Street

Slough

SL2 4HL


Employer's website

https://www.fhft.nhs.uk/ (Opens in a new tab)


Employer contact details

For questions about the job, contact:

Head of Research and Innovation

Swapna Thomas

swapnathomas@nhs.net

07584385489

Details

Date posted

28 November 2025

Pay scheme

Agenda for change

Band

Band 6

Salary

£40,617 to £48,778 a year per annum incl HCAS

Contract

Fixed term

Duration

2 years

Working pattern

Full-time

Reference number

151-KM104

Job locations

Wexham Park Hospital

Wexham Street

Slough

SL2 4HL


Supporting documents

Privacy notice

Frimley Health NHS Foundation Trust's privacy notice (opens in a new tab)