Job overview
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:
•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.
Detailed job description and main responsibilities
Person specification
Education/Qualifications
Essential criteria
1. Degree qualification (e.g. BSc) in a relevant subject
2. Recognised Good Clinical Practice certification.
3. Commitment to continued professional development
Desirable criteria
4. Higher degree qualification (e.g. MSc) in a relevant subject
5. Project management qualification
Experience
Essential criteria
6. Significant experience of working with/on research involving clinical data (data-driven, databases, AI and software as medical device which use algorithms/AI).
7. Experience of working in an NHS or HEI environment in a clinical research governance role.
8. Experience of working with staff from a range of backgrounds and different levels of seniority.
Desirable criteria
9. Experience of developing a strong culture of customer service.
10. Experience of working across organisations
11. Experience of delivering training sessions
12. Experience of project management.
Skills / knowledge
Essential criteria
13. 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.
14. Exceptional understanding of information governance and application in healthcare; in particular familiarity with research related Data Protection Impact Assessments.
15. Basic understanding of IT security standards in the NHS
16. Ability to work constructively as an individual; as part of a closeknit team; and as part of a wider research community
17. Ability to summarise and explain complex issues to both technical and non-technical audiences.
18. Willing and able to coach and train others
19. Ability to work in a proactive manner to identify new risks and issues and flag upwards appropriately.
20. 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.
21. Able to work under pressure, methodical in approach, with effective problem-solving ability
22. Excellent IT literacy: evidence of competence with MS Office, particularly Excel, Word, PowerPoint, Teams and Access
Desirable criteria
23. Knowledge and understanding of research funding streams and award bodies.
24. Understanding of issues relating to intellectual property and ensuring fair value for the NHS relating to data-driven research
25. Awareness of international differences in data protection legislation and legal requirements for research.
26. Line management of staff.
The Royal Marsden values diversity and is committed to the recruitment and retention of underrepresented minority groups. We particularly welcome applications from Black, Asian and minority ethnic candidates, LGBTQ+ candidates and candidates with disabilities.
As a Disability Confident Employer, we are working to create a workplace that enables all staff to reach their full potential. We are committed to this because we know that greater diversity and inclusion will lead to an even greater positive impact for the people we serve.
Due to the high volumes of applications we receive, we reserve the right to close any adverts before the published closing date once we have received a sufficient number of applications. We advise you to submit your application as early as possible to prevent disappointment.
Flu Vaccination – What We Expect of our Staff
At The Royal Marsden we have an immune compromised patient population who we must protect as much as we can against the flu virus. Each year, seasonal flu affects thousands of people in the UK. Occurring mainly in winter, it is an infectious respiratory disease capable of producing symptoms ranging from those similar to a common cold, through to very severe or even fatal disease.
The wellbeing of our staff and patients is of the upmost importance to us, and it is the expectation of The Royal Marsden that all patient-facing staff have an annual flu vaccination, provided free of charge by the Trust.
Employer certification / accreditation badges