Senior Research Governance Facilitator

1 week ago

Nottingham, Nottingham, United Kingdom Nottingham University Hospitals NHS Trust Full time
The post-holder will be a member of the NUH R&I department. The post holder will be responsible for a portfolio of research projects sponsored by NUH.

The post holder will be responsible for this portfolio of studies throughout the different stages of the sponsorship management process:

feasibility, risk assessment, confirmation of capacity, ethical & governance review and study set up, monitoring compliance to Good Clinical Practice (GCP), audit and inspection and finally study closure.

The post holder will be responsible for promoting and developing a culture that supports high quality research through help and support to research leaders and their teams with a focus on NUH sponsored studies.

The post holder will also participate in preparing for external audits and MHRA inspections.

The post of SRGF is central to our commitment to deliver research studies of the highest quality to time and target

  • The post holder will contribute to the preparation and review of R&I policies.
  • The post holder will contribute to the preparation, review and writing of standard operating procedures and other study related documents.
  • The post holder will establish and maintain effective working relationships with all relevant organisations and individuals, including key service support departments within the Trust, East Midlands CRN, other UKCRN research networks, other providers of NHS services within the LCRN, local Higher Education Institutions, Industry, and NHS commissioners.
  • The postholder will maintain a strong and current working knowledge of developments regarding clinical research management, regulation and governance, NHS structures and services and inform and guide R&I staff accordingly.
  • The post holder must ensure GCP and R&I SOP training is complete and their training records are up to date.
  • The post holder will be involved in the implementation of assigned Corrective Action Preventative Actions (CAPA) plan(s), within their respective areas.
More specifically, the post holder will support the Head of Research Governance, Quality and Integrity

NUH sponsors and hosts a comprehensive portfolio of research projects.

NUH works in close partnership with the East Midlands Clinical Research Network (CRN) to provide a timely, proportionate and pragmatic research approvals service for both portfolio and non-portfolio studies conducted within NUH.

The Trust has established robust pharmacovigilance and quality assurance systems in order to ensure patient safety and data quality during the conduct of clinical trials.

The post-holder will be a member of the NUH R&I department. The post holder will be responsible for a portfolio of research projects sponsored by NUH.

The post holder will be responsible for this portfolio of studies throughout the different stages of the sponsorship management process:

feasibility, risk assessment, confirmation of capacity, ethical & governance review and study set up, monitoring compliance to Good Clinical Practice (GCP), audit and inspection and finally study closure.

The post holder will be responsible for promoting and developing a culture that supports high quality research through help and support to research leaders and their teams with a focus on NUH sponsored studies.


SPONSORSHIP APPLICATIONS AND APPROVALS

  • Act as the sponsor point of contact within NUH and for outside organisations.
  • Review medical device Technical Files to ensure all regulatory essential requirements are met.
  • Review sponsorship requests in accordance with NUH policy, with the UK Policy Framework for Health and Social Care Research, Good Clinical Practice (GCP) and appropriate Clinical Trials/medical device Regulations.
  • Engage with other teams within R&I, NUH and other organisations to ensure the feasibility of the study.
  • Perform study feasibilities, risk assessments and complete Schedule of Events for NUH sponsored studies.
  • Support research teams to assess capacity and capability to deliver the proposed NUH sponsored study at NUH.
  • Liaise with the R&I Research Contracts team to ensure the legal requirements of the study are met and that appropriate contracts and insurance are in place prior to research commencing at any site.
  • Ensure all study vendors are reviewed in accordance with Vendor Management process.
  • Work with study teams to develop documentation required for the study and support the researcher during the submission to the relevant approval bodies via IRAS. Support and facilitate queries from relevant approval bodies.
  • Ensure sponsorship data is captured in Documas.
  • Effectively disseminate information on research governance procedures to all staff, independent contractors, researchers, service users, carers and members of the public.
  • Work within Trustwide policies and procedures relating to Research and Research management where appropriate, working to ensure that documents are prepared to a high standard and delivered on time.

STUDY SPONSORSHIP MANAGEMENT

  • Work with R&I

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