Senior Research Governance Officer: Clinical Data

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Detailed job description and main 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:
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.

Person specification

Education/Qualifications

Essential criteria

• Degree qualification (e.g. BSc) in a relevant subject
• Recognised Good Clinical Practice certification.
• Commitment to continued professional development

Desirable criteria

• Higher degree qualification (e.g. MSc) in a relevant subject
• Project management qualification

Experience

Essential criteria

• 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 criteria

• 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 criteria

• 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 criteria

• 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.

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.

All applicants will be contacted by email to the address supplied on your application. Applicants are advised to check their email accounts regularly and to ensure that email filters are set to allow our emails.

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

Documents to download

• Job Description and Person Specification (PDF, 811.5KB)
• Job Features Form (PDF, 128.6KB)
• Royal Marsden Trust Values (PDF, 715.5KB)
• Workplace Wellbeing and Rewards Guide (PDF, 1.2MB)