Job Overview 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. Working for our organisation 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 Detailed Job Description And Main Responsibilities To act as an expert resource and is responsible for ensuring all elements of study 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 Trust’s 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 FHFT’s 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 criteria 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 criteria Good Clinical Practice Certificate Experience Essential criteria 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 criteria Experience of submitting external grant applications Awareness of Trust Sponsorship processes Skill and Knowledge Essential criteria 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 Frimley Health NHS Foundation Trust (FHFT) is proud of its strong reputation, record of achievement and ambition for the future. We serve a population of over 900,000 people across Berkshire, Hampshire, Surrey and South Buckinghamshire, and remain committed to improving the health and wellbeing of our communities. Our new organisational strategy – FHFT 2030 – sets out our ambition to be the best place to receive care and the best place to work in the NHS. Underpinned by our Trust values – Committed to Excellence, Working Together, Facing the Future, and being a modern, compassionate, Healthcare Organisation – we are creating a culture where our people can thrive and patients always come first. We continue to invest heavily in our services and facilities. This includes the development of a new hospital at Frimley Park, major expansion of diagnostics and inpatient capacity, and the continued transformation of services across our sites. We have already delivered a brand-new £100m state-of-the-art Heatherwood Hospital, a £49m Emergency Assessment Centre at Wexham Park, and a £10m upgrade to maternity services. We are also committed to sustainability and the NHS Net Zero ambition. Our new hospital and estate developments are being designed to be environmentally responsible, energy efficient, and future-proofed, featuring on-site renewables energy and intelligent energy systems. Through our green plan, we are embedding sustainable practices across all areas of care and operations, ensuring we reduce our environmental impact while improving population health and wellbeing. Our staff are key to helps us deliver on our ambition and to ensure sustainability is a core component of care delivery and our operations. Alongside estates’ investments, we are embedding a strong focus on digital innovation and quality improvement. Our electronic patient record (Epic), launched in 2024, is already enabling safer, more connected, and more effective care for patients, while giving staff the tools they need to do their best work. Our electronic patient record also supports safe and effective digitised care pathways, savings time and carbon, whilst delivering excellent quality of care. Everything we do is guided by our values, shaping how we care for patients, support colleagues, and build a sustainable future for healthcare together. Apply online now