Research Assurance sit within the Department of Business Assurance and the Office of the Chairman & College Secretariat and are responsible for overseeing the provision of a range of assurance services to the Research & Researchers Function within King’s. The Research Assurance team primarily report to the Chief Compliance Officer and support the Chief Compliance Officer in reporting to University Executive, College Council, relevant University committees and the Vice-Chancellor & President in order to contribute to a robust governance framework within the University and an effective culture of process improvement. 

The team provide subject matter expertise across the research portfolio, including to the wider academic and professional services communities, and support in relation to research governance, compliance, risk management and clinical trials. The work of the team includes undertaking exercises and studies relating to compliance and risk management oversight. They play a key role in the sound governance of the institution and are an integral part of the network to promote continual improvement within the University.

The key responsibility of Research Assurance is to provide appropriate and effective assurance oversight for the Research & Researchers Function. The range of work that the Research Assurance team undertake is aimed at providing assurance on risk management, regulatory and legislative compliance, value for money and operation of controls.

The team’s core functions cover all aspects of activity in the Research & Researchers Function, including undertaking comprehensive due diligence on external entities in compliance with funder requirements and national and international regulations and actively engaging with the research community (and those who support them) to provide guidance, training and advisory services in relation to risk management and compliance to regulations, legislation, funder terms and conditions and internal policies and procedures. The Research Assurance team support the Chief Compliance Officer by undertaking pre-scheduled and ad-hoc assurance reviews and investigations and producing reports for University Executive, College Council, relevant University committees and the Vice-Chancellor & President in relation to research activity. The Research Assurance team are also a key point of contact for external regulators in matters relating to research.

Further detail on Research Assurance’s core functions:

Provision of support for effective assurance oversight and risk management for the Research & Researchers Function

~ Supporting the establishment and maintenance of a robust governance framework within the University

~ Providing assurance in matters of research policy and research project or research programme management

~ Development of risk assessment tools, checklists and associated pathways to aid the management and protection of the University’s research activities in line with current UK government guidance and legislation including the Trusted Research initiative and international regulations such as Import and Export Controls, government sanction listings and the National Security and Investment Act

~ Supporting effective risk management in all systems within the Research & Researchers Function including close collaboration on the on-going development of any research systems

~ Building effective links and, where possible, efficient integrations with other areas of the University

~ Working closely with the University’s Research Governance, Ethics and Integrity Office to ensure adherence to the Concordat to Support Research Integrity and provision of support and expert advice in relation to governance and sponsorship matters

~ Developing and maintaining relationships with risk management leads in partner institutions and sponsors, particularly in King’s Health Partners (KHP) and the associated NHS Trusts, in order to support effective risk management for all research activity within the University

Development and maintenance of the University’s due diligence framework for research

~ Undertaking due diligence on our research partners in accordance with published guidance from major research funders including National Institute of Health Research (NIHR), Wellcome Trust and UK Research and Innovation (UKRI)

~ Undertaking due diligence on commercial funders, overseas government funders and service providers in accordance with University processes and procedures

~ Undertaking due diligence in connection with opportunities for potential third-stream income to include licencing and patents in accordance with University processes and procedures

~ Reporting on due diligence activities to University Executive, relevant University committees and funders as well as overseeing due diligence related risks on project risk registers

Internal assurance reviews and investigations

~ Undertaking assurance reviews and investigations in relation to specific areas of the University’s research activities as established through the Audit, Risk and Compliance Committee and the Senior Vice-President (Operations) or University Executive

~ Undertaking of ad-hoc assurance reviews and investigations in connection with specific projects, activities or research integrity requests

~ Production of comprehensive reports for University Executive, College Council, relevant University committees and the Vice-Chancellor & President

~ Supporting the establishment and maintenance of an effective culture of process improvement

Co-ordination of certain regulatory and research funder audits

~ Acting as the lead (alongside the appropriate function leads) for any external agency or funder wishing to undertake audits of the University’s management of research grants or to carry out other reviews of research management working closely with the Senior Vice-President (Operations), Vice-President (Finance) and the Operations Director (Research & Researchers)

~ On behalf of the Operations Director (Research & Researchers) and in collaboration with the Director of Service Improvement & Operations, identifying key stakeholders in order to manage, co-ordinate and support visits from external agencies and funders in response to their requests

~ Supporting the establishment and maintenance of an effective culture of process improvement

Training and guidance

~ Providing expert advice on compliance and risk management to staff within the Research & Researchers Function, principal investigators and their academic teams and professional services staff within faculties in relation to all aspects of research management

~ Engaging with the research community (and those who support them) to provide appropriate training opportunities (in consultation and collaboration with the Research Management and Innovation Directorate (RMID) unit heads) in order to mitigate risk and ensure compliance with legislation, regulations and funder terms and conditions

Other

~ Representing the interests of the Research & Researchers Function’s activities in national surveys or reports to regulators, professional bodies, associations or member groups or on specific project or programme boards where formally invited

~ Supporting RMID with escalation issues in relation to Pre- and Post-Award grant management activities when there is a need to seek further scrutiny

In addition to the overarching governance role, the Director of Research Assurance also undertakes operational support for the Research & Researchers Function and, specifically, the KHP Clinical Trials Office (KHP CTO) the Research Governance Office (RGO) and RMID's Pre-Award and Contracts Teams. Core functions include:

~ Leading on non-commercially sponsored CTIMP (Clinical Trial of an Investigational Medicinal Product), ATIMP (Advanced Therapy Investigational Medicinal Product) and Medical Device activities that fall outside the standard grant award or government contract process

~ Supporting the co-ordination and management of clinical trial site and service agreements with the KHP CTO, Clinical Trials Unit (CTU), King’s Health Partners (KHP) and other relevant entities

~ Collaborating with the Director of the CTO and Quality Manager on the development and negotiation of sponsorship agreements with all external co-sponsors

~ Delivery of pharmacy, IMP supply agreements and device loan arrangements and other related agreements including manufacturing, distribution and associated quality and technical agreements

~ Supporting the co-ordination and management of Medical Device agreements and manufacturing arrangements in collaboration with the Research Governance Office (RGO) and respective Contract teams within King’s Health Partners (KHP)

~ Providing expert advice on complex sponsorship issues associated with non-commercially sponsored clinical trials including CTIMP, ATIMP and Medical Device issues falling outside of the standard process and communicating such advice to the Operations Director (Research & Researchers), Director of the CTO and, where relevant, other Service Portfolio Leads

~ Providing expert advice and support on procurement and insurance arrangements connected to clinical trial activity working closely with KCL professional service leads in Finance and King’s Health Partners (KHP)