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The Role of the Research Office

The Role of the Research Office. Joint Research & Enterprise Office (JREO) St George’s University of London and St George’s University Hospitals NHS Foundation Trust. MaryCate MacLennan R&D Performance & Delivery Manager. What does a Research Office do ?. FINANCES & LEGAL

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The Role of the Research Office

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  1. The Role of the Research Office Joint Research & Enterprise Office (JREO) St George’s University of London and St George’s University Hospitals NHS Foundation Trust MaryCate MacLennan R&D Performance & Delivery Manager

  2. 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 protocol • ETHICS/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 inspections • STRATEGY • 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

  3. What are the regulations* Medicines for Human Use (Clinical Trials ) Regulations 2004 *list not exhaustive Joint Research & Enterprise Office Training

  4. SGUL Council Trust Board Strategy, Planning & Resources Executive Management group Senate Quality & Risk Finance & Performance Commercial Audit Finance Joint Executive Group Risk Management Patient Safety Research Strategy Committee Joint Clinical Research Committee Joint Research Governance Committee Delivery / Management Risk, Compliance, Assurance Strategy Troika JREO Research Facilities

  5. Structure Joint Research & Enterprise Office Training

  6. Who do we deal with? Joint Research & Enterprise Office Training

  7. How we interact internally within our JREO Joint Research & Enterprise Office Training

  8. How we interact internally within our JREO Joint Research & Enterprise Office Training

  9. 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 Joint Research & Enterprise Office Training

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