Detailed job description and main responsibilities

 Advice and Support

•  To act as a first point of contact for researchers receiving queries by telephone, e-mail and in person and an ability to guide them clearly through the complicated R&D application process.  Researchers may be very experienced or may be attempting their first forays into research.  The ability to target and adapt communication style is therefore crucial.

 §  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.

 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 across the R&D Office, Governance, Finance, Clinical 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 requirements. 

·       To manage the completeness of project-related documentation uploaded onto EDGE, and the extraction of reporting based upon this data.

 ·       To draft and issue appropriate Confirmation of Capability and capacity emails, containing accurate information and to disseminate copies to all relevant parties in a timely and professional manner.

·       Liaise with the R&D Finance team to ensure that Clinical Trials Agreements are in place and the studies are fully costed before confirmation of capability & capacity is given.  Making the Finance and research delivery teams aware of any potential study delays.

 ·       Liaise with the R&D Governance Team where appropriate and particularly to deliver timely Snr Manager check signoff.

 ·       Oversee the amendments process and manage complex amendments.

 ·       Proven understanding of study status, compiling data into reports and escalating issues.

Meetings and Reporting

 §  To lead on weekly set-up meetings to discuss progress of commercial and non-commercial studies in set up and further to follow-up any actions identified at the meeting.

§  To support R&D clinical teams, ensuring local projects are delivered to time and target and to represent the Research Operations Manager as appropriate when they are unavailable

 §  To populate EDGE database as appropriate with information relating to study set-up.  This includes identifying essential study aspects, reporting and tracking of any delays along with associated reasons.  These reports are then used for statistical analysis against internal and external higher level objectives.

 §  To support and work collaboratively with other South West Peninsula Trusts, including where required attending meetings/Webinars etc., with the aim of delivering a high quality R&D service across the whole region. 

§  To work alongside other UK RDNs to achieve overall study targets.

 §  To facilitate South West Peninsula-wide updates of studies in feasibility, and identify any potential problems with set up.

§  To check data provided periodically by the RDN SWP relating to local study set up and confirm information is accurate and correct, reporting discrepancies accordingly.

 §  To maintain an effective office filing system, recording information relating to studies in set up and approved ongoing studies through to completion. 

• Assist the R&D Office team in maintaining the portfolio of active studies within the Trust, working, closely alongside other members of the R&D team, the clinical trials team and various RDN SWP teams.

 Study Data Management

 ·       To have a clear understanding of the function and use of the R&D office databases.

§   §  To identify, collate and enter accurate information and data using a combination of (mainly) electronic and (historic) paper based R&D filing systems.

 §  To be responsible for complex data collection on the portfolio of studies as per Good Clinical Research Practice regulations (GCP). 

General

 §  Participate in R&D Office team meetings and actively contribute to process and procedural reviews.

 §  To respond quickly and appropriately to all enquiries and queries, directing to most appropriate team member.

 §  Assist teams in preparation of accurate research reports and presentations.

 §  Able to work within related policies, procedures and regulatory requirements e.g. GDPR, individual Trust policies

 §  General clerical office management duties as need arises, including providing cover for the other Research Support Facilitators

 §  To take part in regular personal development review.

 §  To support R&D office managers with anything else deemed appropriate to the role and grade.