Senior Research Governance Facilitator
6 months ago
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 Trust-wide 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 finance to ensure all research study budgets, costs and funding sources are appopriately managed and a clear audit trail maintained. Support research-related financial management in NUH. This includes working with the R&IDivisional Team to maintain appropriate financial systems to support research and R&I income where required.
Maintain sponsor files and Trial Master Files (electronic and hard copy) in accordance with GCP essential requirements. Support the research teams in identifying and resolving barriers for the delivery of NUH sponsored research projects and escalating issues as appropriate. Support the management and set-up of multi-site studies (where appropriate) by working with the CI and their team and liaising with other site investigators. Co-ordinate and facilitate Site Initiation visits for NUH sponsored research.
Ensure all queries and issues are addressed prior to issuing C&C/greenlight. Prepare and implement a risk based and robust monitoring plan for studies sponsored by NUH. Act as a clinical trials monitor, by conducting ongoing monitoring visits for NUH sponsored studies according to their monitoring plan, where applicable. Support and facilitate the close out of monitoring queries.
Facilitate GCP and R&I SOP training. Ensure training records for research teams are up to date. Act as R&I pharmacovigilance facilitator for CTIMPs by ensuring: o SAE reports are processed and sent to medical monitor, all follow
- up reports are processed and reviewed by the medical monitor. All SAEs are reconciled on a regular basis.
If required, ensure SUSARs are reported to the MHRA within the timelines. Support the study team in preparing amendments, ensure all study amendments are reviewed and classified correctly i.e. minor or substantial. Support the submission of amendments to the relevant approval body.
And address queries from the relevant approval bodies. Review and approve all protocol deviations, violations and breaches. Report violations and breaches to the relevant approval bodies. Support the research team to investigate root causes and implementation of corrective and preventative actions.
Prepare internal systems deviations reports and support the implementation of corrective and preventative actions Ensure all clinical research databases are up to date e.g. ClinicalTrials.gov or Eudract. Attend all relevant Trial Management Group/Trial Steering Committees. Support the Head of Research Governance, Quality and Integrity in preparing sponsor research metrics.
Support research teams in the preparation of APRs and DSURs and ensure that they are submitted to the regulatory authorities within the timelines Support the preparation of end of study reports and ensure that they are submitted to the regulatory authorities within the timelines. Support research teams during study close out Ensure all Investigator Site Files and Trial Master Files are archived according to requirements in conjunction with the QA manager/archivist. Work with the R&I Divisional Team to maintain up-to-date records of performance data and escalate any performance issues to senior R&I management.
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Senior Research Governance Facilitator
6 months ago
Nottingham, United Kingdom Nottingham University Hospitals NHS Trust Full timeThe 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 &...
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