Job summary
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.
Main duties of the job
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:oLead 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.
About us
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.
Job description
Job responsibilities
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:oInitiating, 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.oMaking 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.oEnsuring that research applications have been costed appropriately.oWorking 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.oReview amendments and independently determine if the changes made will affect research governance and action as appropriate.oProvide specific governance advice to enable appropriate classification of research involving clinical data, and input into research related Data Protection Impact Assessments.
Job description
Job responsibilities
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:oInitiating, 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.oMaking 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.oEnsuring that research applications have been costed appropriately.oWorking 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.oReview amendments and independently determine if the changes made will affect research governance and action as appropriate.oProvide specific governance advice to enable appropriate classification of research involving clinical data, and input into research related Data Protection Impact Assessments.
Person Specification
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), and 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 closeknit 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 in a proactive manner to identify new risks and issues and flag upwards appropriately.
- Excellent communication, persuasion, listening and strong interpersonal skills as well as attention to detail and a sharp analytical mind and an ability to think laterally.
- Able to work under pressure, methodical in approach, with effective problem-solving ability
- Excellent IT literacy: evidence of competence with MS Office, particularly Excel, Word, PowerPoint, Teams and Access
Desirable
- Knowledge and understanding of research funding streams and award bodies.
- Understanding of issues relating to intellectual property 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.
Person Specification
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), and 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 closeknit 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 in a proactive manner to identify new risks and issues and flag upwards appropriately.
- Excellent communication, persuasion, listening and strong interpersonal skills as well as attention to detail and a sharp analytical mind and an ability to think laterally.
- Able to work under pressure, methodical in approach, with effective problem-solving ability
- Excellent IT literacy: evidence of competence with MS Office, particularly Excel, Word, PowerPoint, Teams and Access
Desirable
- Knowledge and understanding of research funding streams and award bodies.
- Understanding of issues relating to intellectual property 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.
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
