Overview
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 The Royal Marsden and 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.
Responsibilities
* 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.
* Liaise regularly with staff across all levels of the organisation, providing guidance and advice to ensure compliance with the regulatory requirements including the UK Policy Framework for Health and Social Care, UK General Data Protection Regulation and Data Protection Act, and Medical Devices Regulations.
* Be responsible for improving processes and procedures for research involving clinical data, recommending and leading system change and development, and sitting on relevant committees. This will involve significant oversight and input into our institutional research database with generic NHS research ethics approval (The Royal Marsden Cancer Datastore) and the Data and Tissue Access Request Service (DTARS).
* Coordinate and provide expert advice on all aspects of research involving clinical data (data-driven, databases, AI and software as medical device which use algorithms/AI); liaise with corporate legal services, information governance and digital/informatics colleagues at The Royal Marsden and the ICR. Undertake reviews of research involving clinical data submitted for sponsorship by The Royal Marsden and the ICR and reviewed by the Committee for Clinical Research (CCR) or Data and Tissue Access Committee (DTAC).
* Initiate, develop and lead the delivery of the review process of relevant research applications, identify areas that are inconsistent or unclear, communicate with the researcher any changes or further information required, and identify regulatory review requirements.
* Make definitive judgments on relevant research applications to determine whether projects are compliant with current governance and regulatory frameworks and legislation.
* Ensure research applications are costed appropriately. Work with corporate legal services, information governance and digital/informatics colleagues to ensure necessary legal contracts (including data sharing agreements) cover data flows.
* Review amendments and independently determine if changes affect research governance and action as appropriate. Provide specific governance advice to enable appropriate classification of research involving clinical data, and input into Data Protection Impact Assessments.
Qualifications
Education/Qualifications
Essential
* Degree qualification (e.g. BSc) in a relevant subject
* Recognised Good Clinical Practice certification
* Commitment to continued professional development
Desirable
* Higher degree qualification (e.g. MSc) in a relevant subject
* Project management qualification
Experience
Essential
* Significant experience of working with/on research involving clinical data (data-driven, databases, AI and software as medical device which use algorithms/AI).
* Experience of working in an NHS or HEI environment in a clinical research governance role.
* Experience of working with staff from a range of backgrounds and different levels of seniority.
Desirable
* Experience of developing a strong culture of customer service.
* Experience of working across organisations
* Experience of delivering training sessions
* Experience of project management
Skills / knowledge
Essential
* Expert knowledge of Good Clinical Practice (GCP), UK Policy Framework for Health and Social Care, UK General Data Protection Regulation (GDPR) and Data Protection Act (DPA), Medical Devices Regulations (MDR), and the Common Law Duty of Confidentiality, and best practice from the Information Commissioner.
* Exceptional understanding of information governance and application in healthcare; in particular familiarity with research related Data Protection Impact Assessments.
* Basic understanding of IT security standards in the NHS.
* Ability to work constructively as an individual; as part of a close-knit team; and as part of a wider research community.
* Ability to summarise and explain complex issues to both technical and non-technical audiences.
* Willing and able to coach and train others.
* Ability to work proactively to identify new risks and issues and flag upwards appropriately.
* Excellent communication, persuasion, listening and strong interpersonal skills, attention to detail, and analytical thinking.
* Able to work under pressure, methodical in approach, with effective problem-solving ability.
* Excellent IT literacy: MS Office (Excel, Word, PowerPoint, Teams and Access).
Desirable
* Knowledge and understanding of research funding streams and award bodies.
* Understanding of IP issues and ensuring fair value for the NHS relating to data-driven research.
* Awareness of international differences in data protection legislation and legal requirements for research.
* Line management of staff.
Disclosures
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and a submission for Disclosure to the Disclosure and Barring Service may be required to check for any previous criminal convictions.
Employer details
The Royal Marsden NHS Foundation Trust
The Royal Marsden Sutton, Sutton, SM2 5PT
Employer website: https://www.royalmarsden.nhs.uk/working-royal-marsden
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