Job overview
The post holder will support the Clinical Director of R&D, Associate Director of R&D and R&D Governance Manager in delivering high-quality research activity across Hampshire Hospitals NHS Foundation Trust in line with national standards and regulatory requirements.
The role involves supporting the set-up and governance of research studies, ensuring compliance with relevant legislation, research governance requirements, contractual obligations, ICH-GCP, the HRA approval process and the UK Policy Framework for Health and Social Care Research. This includes detailed review and tracking of study documentation through to confirmation that studies are ready to open.
The post holder will work closely with internal and external stakeholders including investigators, sponsors, research nurses, trial coordinators, clinicians and support services to facilitate timely and effective study set-up and delivery. They will maintain accurate records of trust-wide research activity using agreed systems, prepare reports for the R&D management team, and support performance monitoring across clinical divisions and departments.
The post holder will also provide advice and guidance to researchers within the Trust and contribute to the wider work of the R&D Office, including sponsored research oversight, commercial partnerships, research strategy, study set-up and research archiving.
Main duties of the job
·Together with the Associate Director of R&D and R&D Governance Manager, be responsible for the delivering of the divisional R&D targets
·Facilitate the research confirmation process and be responsible for obtaining required authorisations on behalf of researchers
·Ensure studies run within the division are on time and to target
·Assist with feasibility assessments and costing research
Working for our organisation
Our vision is to provide outstanding care for every patient. Patient care is at the heart of what we do at our three sites: Basingstoke and North Hampshire Hospital, Royal Hampshire County Hospital in Winchester and Andover War Memorial Hospital. Hampshire Hospitals NHS Foundation Trust provides medical and surgical services to a population of approximately 600,000 people across Hampshire and parts of West Berkshire.
Our cultural ambition is to have a culture that places people at the heart of all we do, where we all belong, and where learning, improvement and excellence thrive.
We provide specialist services to people across the UK and internationally. We are one of only two centres in the UK treating pseudomyxoma peritonei (a rare form of abdominal cancer) and we are leaders in the field of tertiary liver cancer and colorectal cancer.
The trust employs more than 9,000 staff and has a turnover of over £500 million a year. As a Foundation Trust, we are directly accountable to our members through the governors. The Council of Governors represent the interests of their constituencies and influence the future plans of the Foundation Trust.
Your Next Career Move Made Easier – Accommodation May Be Offered
We understand relocating can be a big step. Hampshire Hospitals may be able to provide accommodation options for successful candidates, depending on availability. If this something you would like to explore please contact on 02080 360017
Detailed job description and main responsibilities
Study Management
Project identification and feasibility
1. Identify NIHR Portfolio studies suitable for Trust participation and support identification of Principal Investigators.
2. Work with clinicians to assess interest, scope, and barriers to participation.
3. Lead feasibility assessments with external partners (NIHR, commercial, networks).
4. Determine resource and staffing requirements and coordinate solutions across the Trust.
5. Provide advice on funding, training, portfolio adoption, approvals, and systems (e.g. IRAS, EDGE).
Study Set-up
6. Support efficient study set-up from expression of interest through to site opening.
7. Ensure all studies are registered, documented, and compliant with Trust policy, HRA, ethical and legal requirements.
8. Promote new study opportunities and support feasibility assessment.
9. Coordinate approvals and amendments, including: Local feasibility review Contract and budget negotiation Compliance with legislation Assessment of research team capability Coordination with support services (pharmacy, pathology, radiology) Issuing Letters of Access/Honorary Contracts
10. Maintain communication with researchers on study status.
11. Liaise with R&D leadership to ensure workforce capacity for new and amended studies.
Study Support
12. Support prioritisation and workload management to maintain timelines.
13. Maintain EDGE as the central system for study tracking and activity recording.
14. Monitor study progress, documentation, and set-up workflows.
15. Support recruitment initiatives within clinical departments.
16. Collect and report recruitment data for internal and external stakeholders.
17. Provide ongoing governance and reporting support to study teams.
18. Facilitate MHRA inspections, including preparation, coordination, and follow-up.
Person specification
Qualifications
Essential criteria
19. Educated to degree or equivalent knowledge and skills gained through any combination of alternative study, employment or voluntary work
20. Evidence of continuing professional development
Desirable criteria
21. Good Clinical Practice (GCP) training within the last 2 years
22. Experience of critical appraisal of research evidence/evidence based medicine
Knowledge
Essential criteria
23. An understanding of the systems and processes which are used to support the delivery of high-quality clinical care
24. An understanding of R&D issues in the NHS
25. Understanding of governance and quality assurance systems to ensure safe systems for patients
26. Project management experience
Desirable criteria
27. Experience of working in the NHS
28. Personal research experience
29. Commercial research experience
30. Previous experience in using IRAS database for R&D applications
Skills
Essential criteria
31. Enthusiastic, resolute and flexible approach to work
32. Extensive IT and IS skills including Microsoft Office
33. Excellent communication skills both written and verbal with the ability to communicate with different professions, both internal and external
34. Excellent presentation skills
Desirable criteria
35. Critical appraisal and analytical skills for interpreting qualitative and quantitative information
36. A high level of numeracy with the ability to interpret statistical and epidemiological data
37. Knowledge of EDGE/ IRAS
38. Experience of internet research
39. Experience of delivering training