The Role of the Research OfficeJoint Research & Enterprise Office (JREO)
St George’s University of London and St George’s University Hospitals NHS
Foundation Trust
MaryCate MacLennanR&D Performance & Delivery Manager
What does a Research Office do?FINANCES & LEGAL•Identification of research funding opportunities•Costings and pre-award support for grant applications•Financial management and administration of research grants and contracts•Costing of (commercial) clinical studies•Commercial/IP implications•Contracts •Distribution of funds to all departments involved in the protocolETHICS/GOVERNANCE & COMPLIANCE•Providing guidance on the Ethics process•Sponsorship of clinical research studies•Host site approval for clinical research studies•Clinical and Research Governance on site (including study initiation, audit and monitoring, safety reporting, and study close-out)•Co-ordinating external audits and regulatory inspectionsSTRATEGY•Partially responsible for delivering the Research Strategies•Monitoring and reporting on research activity•Training and guidance for researchers•Supporting teams to think about future resourcing, plans, ambitions•Connecting researchers/support departments
Joint Research & Enterprise Office Training
What are the regulations*
Medicines for Human Use (Clinical Trials ) Regulations
2004
*list not exhaustive
Joint Research & Enterprise Office Training
SGUL Council Trust Board
Stra
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Fina
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Sena
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Exec
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Patient Safety
Joint Executive
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Research Strategy Committee
Joint Clinical Research Committee
Joint Research Governance Committee
Strategy Delivery / Management Risk, Compliance, Assurance
Research Facilities
JREO
Troika
Risk Management
Audi
t
Structure
Joint Research & Enterprise Office Training
Who do we deal with?
Joint Research & Enterprise Office Training
Joint Research & Enterprise Office Training
How we interact internally within our JREO
Joint Research & Enterprise Office Training
How we interact internally within our JREO
Joint Research & Enterprise Office Training
What we have done in the last 2 years – key areas.
• Audits – 31 studies audited 2013 and 2014. 7% of all studies active at St Georges. (10% is the target)
• Had 2 MHRA inspections , 1 FDA inspection• Trained 277 people on Good Clinical Practice.• Trained about 161 people on our training courses• Updated existing 19 SOPs and added a further 28. And created 19 WPD.• Archived 154 studies* (364 boxes in total)• Increased no of Clinical trials recruiting their 1st patient within 70 days from 50%
(31st Dec 2013) to 80% (31st Dec 2014)• Increased recruitment on CRN recruitment• Largest (in terms of recruitment – not studies) of commercial portfolio in South
London• Investment in research time for clinicians.• Bring new clinical areas into research
