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 
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