Junior Research Support Facilitator

The purpose of this role is to support the R&D Operations Manager in the process of approving, maintaining, amending and closing research projects taking place at University Hospitals Plymouth NHS Trust. In this role it is envisaged that the post holder will learn about the research projects ongoing in a large acute hospital and how to apply the legislation and guidance associated with the safe performance of clinical research in this setting.

For more information, please contact Elinor Pegg

***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 R&D Office facilitates and governs the management of all research projects ongoing in this Trust, from first introduction and feasibility review, through internal approval and active recruitment of patient, and any amendments to project details and finally trial closure and archiving. At any one time there can be approximately 200 feasibilities, almost 100 projects in development and more than 500 active projects. The role of the research support facilitators is to provide administrative support for these projects, as a part of the integrated Research and Development office

We are a people business – where every member of staff matters and can make a difference. Patients are at the heart of everything we do. Joining University Hospitals Plymouth NHS Trust means becoming part of a team of dedicated staff, who are committed to leading the way through innovation, clinical excellence and great customer care. The Trust has great opportunities for career development in a highly progressive working environment. We offer all of this in a vibrant, modern city with a historic reputation for adventure. PLEASE NOTE THAT ALL COMMUNICATION WILL BE ELECTRONIC, PLEASE CHECK YOUR EMAIL ACCOUNT REGULARLY. If you have any issues with applying online and need additional support including reasonable adjustments with the application process please contact the recruitment team on We recognise that work life balance is important for our colleagues and so we invite requests from applicants around less than full time/flexible working for our advertised roles. Please contact the recruiting manager to discuss this prior to your application submission. We commit to giving this full consideration in each case. We encourage people from diverse backgrounds to apply for our roles, as diversity strengthens our teams. It is sometimes necessary to close vacancies before the closing date. If you have not heard from us within 4 weeks of the closing date, please assume that you have not been shortlisted.

Advice and Support

• To act as a first point of contact for researchers, receiving queries by telephone, e-mail and in person

with an ability to guide them clearly to the appropriate person for guidance through the complicated

R&D application processes. 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 become proficient in the use of our web-based electronic research database such as EDGE to enter,

update and retrieve project information, to be able to use the web-based systems eg: NIHR operating

data platform ODP .

• 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 authorisation of R&D Confirmation of Capacity and Capability. The completion of

applications must be organised in a timely and efficient manner.

• Provide effective and timely communication with ethics committees, R&D offices, investigators and the

multi-disciplinary teams, pharmaceutical companies and other research organisations such as the

Universities.

R&D Approvals Facilitation

• Liaise with the R&D Finance team to ensure that Clinical Trials Agreements are in place and the studies

are fully costed before approval is given. Making the R&D Finance team aware of any potential study

delays.

• To learn to identify the different types of R&D projects (Clinical Trial of an Investigational Medicinal

Product [CTIMPs] and non-CTIMPs, device studies, genetics, Phase I, commercial and academic), in

order to make appropriate and accurate judgements concerning their approval and governance

requirements.

• To be aware of and deliver studies 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 learn to complete the necessary governance checks and administration tasks of studies such as

contract type and Statement of Events (SoE). To ensure that all local and study wide checks are up to

date, reflecting information in the R&D study files, in a timely and accurate manner and to be aware of

the implications of inaccuracy.

• Appropriately identify when external researchers may require Research Passports, Honorary Contracts

or Letters of Access for studies and to notify the line manager accordingly, in order to issue the

documents 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 Standard Operating

Procedures (SOPs), International Conference on the Harmonisation of Good Clinical Practice (ICH

GCP) and other regulatory body requirements.

• To draft and issue appropriately signed Trust Approval Letters/emails, containing accurate information

and to disseminate copies to all relevant parties in a timely and professional manner.

For further details please see the attached JD & PS