Senior Research Governance Officer: Clinical Data

An exciting opportunity has arisen for a Senior Research Governance Officer – Clinical Data within the Joint Clinical R&D Core Services team. This role will support the Governance & Operations Team and researchers in both The Royal Marsden and our academic partner the Institute of Cancer Research (ICR).

The ideal candidate will have an exceptional understanding of information governance and its application in clinical research, with a passion for solving complex problems and comfortable in navigating ambiguity to provide clear advice in an environment subject to rapid regulatory change.

The Senior Research Governance Officer: Clinical Data is a senior member of the governance and operations function, sitting within the Joint Clinical Research & Development Core Services. The purpose of the role is to provide expert advice for an expanding portfolio of research involving clinical data (data-driven, databases, artificial intelligence (AI) and software as medical device which use algorithms/AI). This portfolio will be conducted by The Royal Marsden and the Institute of Cancer Research, frequently involving partnerships with industry and academia.

The ideal candidate will have an exceptional understanding of information governance and its application in clinical research, with a passion for solving complex problems and comfortable in navigating ambiguity to provide clear advice in an environment subject to rapid regulatory change.

The post-holder will:

• Lead on the governance, coordination and approval of research involving clinical data (data-driven, databases, AI and software as medical device which use algorithms/AI) throughout the life course of the study. Review and understand highly complex research protocols and assess these for compliance to the relevant regulations. Provide specific governance advice to enable appropriate classification of research involving clinical data, and input into research related Data Protection Impact Assessments.

The Royal Marsden NHS Foundation Trust is a world-leading cancer centre. Our role is to offer our patients the best cancer care available anywhere in the world, and to continue to make a global contribution to finding better ways of diagnosing and treating cancer. We employ over 4,500 staff in a diverse range of careers including nursing, medical, science, radiography, pharmacy, occupational therapy, finance and administrative services. We have two hospitals – one in Chelsea, London, and one in Sutton, Surrey – as well as a Medical Daycare Unit in Kingston Hospital.

At The Royal Marsden, we deal with cancer every day, so we understand how valuable life is. When people entrust their lives to us, they have the right to demand the very best. That's why the pursuit of excellence lies at the heart of everything we do.

At the heart of the hospital is our dedicated team. We offer a stimulating and dynamic working environment, a wide range of staff benefits, learning and development opportunities and clear career pathways. There are opportunities to work flexibly across a range of areas and specialities and we welcome flexible working requests from point of hire to support employees work life balance. We are looking for employees who aspire to excellence, share our values and can play a crucial role in our on-going achievements.

For further information on this role, please see the attached detailed Job Description and Person Specification.

• Working alongside colleagues in the Joint Clinical Research and Development Core Services team, lead on coordinating and providing expert advice on all aspects of research involving clinical data (data-driven, databases, AI and software as medical device which use algorithms/AI) . This will involve close liaison with corporate legal services, information governance and digital/informatics colleagues at The Royal Marsden and the ICR.
• Undertake reviews of research involving clinical data (data-driven, databases, AI and software as medical device which use algorithms/AI) submitted for sponsorship by The Royal Marsden and the ICR and as reviewed either by the Committee for Clinical Research (CCR) or Data and Tissue Access Committee (DTAC). This will include:

o Initiating, developing and leading the delivery of the review process of relevant research applications - identifying any areas of the application that are inconsistent or unclear, communicating with the researcher any changes or further information that is required, and identifying the regulatory review requirements.

o Making definitive judgements on relevant research applications determine whether projects, and therefore The Royal Marsden and the ICR, are compliant with current governance and relevant regulatory frameworks and legislation.

o Ensuring that research applications have been costed appropriately.

o Working with corporate legal services, information governance and digital/informatics colleagues to ensure that necessary legal contracts (including data sharing agreement) are in place to cover data flows.

o Review amendments and independently determine if the changes made will affect research governance and action as appropriate.

o Provide specific governance advice to enable appropriate classification of research involving clinical data, and input into research related Data Protection Impact Assessments.