Research Support Facilitator

5 months ago


Plymouth, United Kingdom University Hospitals Plymouth NHS Trust Full time

The Research and Development department are looking for an enthusiastic, proactive, process driven Band 4 Research Support Facilitator to join our busy, dedicated research support team. You will be responsible for supporting 2 trainee Research Support Facilitators and working in close liaison with the Research Operations Manager and for the day to day prioritisation of study setup. This post is key in supporting the clinical delivery team by proactively managing study setup in line with, amongst others our CRN metrics and University Hospitals Plymouth NHS Trust strategy for the delivery of research. You will need to be conversant with Microsoft Office and the tools within it, such as Outlook, Excel and Word.

**Preference will be given to internal Trust staff, as well as ‘Priority’ and 'At Risk' status including NHS At Risk staff throughout Devon who are able to display recent relevant experience as dictated by the Person Specification.**

The role of a Research Support Facilitator is to provide administrative and data management support for all aspects of trial organisation, as an integrated member of the Research and Development Office.

The role is a very busy one, requiring excellent organisational skills and the ability to prioritise accordingly.

The post holder advocates the safe conduct of research by supporting the principles of the Research Governance Framework and compliance with the International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) Regulations and General Data Protection Regulations 2018. They use their knowledge of these principles to ensure all aspects of a study are compliant and have been completed during study set up.

Advice and Support
- To be expert in the use of the web-based electronic research systems, for example TriNetX, IRAS and ODP, and to be able to support researchers and other staff using these systems. To be able to support research teams in using the web-based database EDGE to enter, retrieve and report on project information.
- Using TriNetX to sense check feasibility requests to allow early responses to sponsors.
- Liaise with and support investigators, research nurses, trial co-ordinators, Clinical Research Network Staff, and external Clinical Research Associates to ensure full trial documentation sets are available and in place before Confirmation of capability and capacity (R&D Approval). The completion of this process must be organised in a timely and efficient manner in order to achieve national targets on which funding is dependent.
- To provide training and assistance to research nurses with the use of the EDGE database. To liaise with research teams and helpdesks to resolve queries/problems and to be a general point of contact for project queries.
- Provide effective and timely communication with the Health Research Authority (HRA), R&D offices, investigators and their multi-disciplinary teams, pharmaceutical companies and other research organisations such as Universities and Clinical Trials Units.
- Mentor and support Junior and Trainee Research Support Facilitator’s to perform their role to time and target.
- To support the training of Junior Trainee Research Support Facilitators against the agree competencies
- Support the R&D Operations Manager to ensure all member of the R&D Operations Team receive regular one to ones and annual appraisals.
- To line manage allocated Junior & Trainee Research Support Facilitators

R&D Approvals Facilitation
- To be able to identify the different types of R&D projects, (CTIMPs and non-CTIMPs, Device studies, GMO, ATMP’s, Phase I, Commercial and Academic), in order to make appropriate and accurate judgements concerning their approval and governance requirements.
- To drive the study feasibility process - disseminating potential study information to the appropriate research delivery teams and potential researchers, and gaining timely feedback on Expressions of Interest.
- To be aware of and deliver study set-up and amendments to national and local targets and timelines, whilst also being sensitive to the wider research environment and understanding the possible impact on a delivery team’s other commitments to research.
- To complete the necessary governance checks and administration tasks of studies as they progress through their set up delivery and archive process. To ensure that all study related documentation is up to date, reflecting information in the R&D study e-files and EDGE, in a timely and accurate manner and to be aware of the implications of inaccuracy.
- Appropriately identify when external researchers may require letters of access or honorary contracts for studies and facilitate accordingly in order to issue in a timely fashion.
- Work closely with integrated teams within the R&D Office and teams across the South West Peninsula in collation of full document sets.
- To set up and maintain R&D study files in accordance with the latest Trust SOPs, ICH GCP and other regulatory body re


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