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Research Assurance

Clinical trials

In addition to the overarching governance role, the Director of Research Assurance also undertakes operational support for the Clinical Trials Office (CTO). Functions include:

  • Lead on non-commercially sponsored CTIMP (Clinical Trial of Investigational Medicinal Product) and ATIMP (Advanced Therapy Investigational Medicinal Product) activities that fall outside the standard grant award or government contract process;

  • Co-ordinate and manage the CTIMP / ATIMP site and service agreements with the CTO, Clinical Trials Unit (CTU), and KHP Trusts;

  • Ensure that the service is delivered within the regulatory and third-party funder deadlines;

  • Collaborate with the Director of the CTO on the development and negotiation of sponsorship agreements with external co-sponsors;

  • Work with the CTO Management Accountant, Head of Post Award and CTO Quality Assurance Manager to identify and facilitate CTO costs to be journaled;

  • Provide expert advice on complex sponsorship issues and non-commercially sponsored CTIMP and ATIMP issues falling outside of the standard process and communicate such advice to the Operations Director (Research & Researchers), Director of the CTO and, where relevant, other Service Portfolio Leads.

 

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