Responsibilities
* Take responsibility for ensuring all clinical trials within the clinical research group are set-up, conducted and managed in accordance with Good Clinical Practice, all relevant Standard Operating Procedures, and relevant legislation / governance.
* Manage and lead the administrative / operational team of the clinical research group.
* Manage and oversee the finances and budget of the clinical research group, ensuring a balanced portfolio which enables sufficient income generation for the sustainability and development of the team.
* Co‑develop and be responsible for the operational delivery of the strategy of the clinical research group, in conjunction with the consultants / researchers and Clinical Research Manager.
* Lead on business development in the research group, to develop a sustainable portfolio of commercial and non‑commercial research in addition OUH Sponsored trials.
* Be a key member of the clinical research group team responsible for coordinating with the clinical and medical members of the team, providing information as required regarding the portfolio and updates.
* Represent the group at relevant meetings, as required.
* Work with the Clinical Research Manager to ensure deployment of clinical skill and expertise as required.
* Co‑develop and be responsible for the operational delivery of the research group strategy alongside the consultants / researchers.
* Manage, collate, maintain and monitor existing research, publications and audit activities and outputs of the research group.
* Seek out and support research opportunities in a bid to increase the numbers of new trials undertaken within the group and in collaboration with other units and external organisations.
* Provide overall financial management of the research unit budget, and effective management of individual clinical trial budgets, including financial reporting as required.
* Act as an authorising signatory for the research budget within limits agreed.
* Manage finances and developing systems in compliance with the relevant standing financial instructions.
* Work with external groups to ensure that research activity is promoted externally and internally with relevant stakeholders.
* Identify gaps in procedure, policy, information and staff knowledge relevant to research within the area of responsibility and devise appropriate systems to fill them and improve performance.
* Attend and represent the group at relevant meetings.
* Ensure facilities and other resources are available to meet service needs, including analysing and managing space requirements.
* Build alliances and working partnerships.
* Observe and comply with the relevant policies and procedures for health and safety ensuring the environment in which you and your staff work is safe, clean and tidy.
* Comply with standard infection control precautions to prevent or minimise the spread of micro‑organisms and communicable diseases to patients, staff and surrounding community.
* Ensure that all clinical trials are delivered in accordance with Good Clinical Practice, relevant Standard Operating Procedures, and relevant legislation and governance.
* Ensure performance against external NIHR benchmarks and internal metrics.
* Conduct feasibility assessments on all research proposals in line with the group research strategy prior to site selection, providing expert advice to the consultants / researchers.
* Be responsible for the prompt set‑up of clinical research, trouble‑shouting to prevent delays.
* Oversee the collection and entry of data into relevant case report forms and into trial databases in a timely manner, and the correct updating of the data validation tool to record patient visits and raise correct invoices in a timely manner.
* Lead on the development and implementation of procedures to ensure continued streamlining and efficient delivery of all clinical trials within the portfolio.
* Meet with the administrative, operational, clinical and consultant colleagues regularly to ensure efficient management of the trials running, providing support and advice on logistical issues.
* Attend meetings with outside organisations, including academic and commercial partners, to support / advise when hosting and / or managing multi‑centre trials.
* Oversee and be responsible for full cost recovery from the delivery of hosted trials – in particular for commercial trials during the national contract value review process and local costing stage.
* Understand and utilise costing methodology for non‑commercial trials (AcoRD).
* Be the named group archivist for all trial related documentation.
* Have oversight of the coordination of safety review for all trials within the portfolio and ensure systems meet sponsor and regulatory requirements.
* Supervise the group portfolio including overseeing feasibility, protocol development, submissions, design of databases and study amendments.
* Line manage the administrative and operational team of the research unit, providing expertise and guidance (trial coordinators and trial administrators).
* Be responsible for the co‑ordination of annual and all other leave for research staff ensuring minimal disruption to the service provided by this team to patients and the wider Clinical Research Directorate.
* Promote a safe working environment and carry out staff assessments in line with occupational health policies.
* Identify workforce requirements with the appropriate skill mix to meet the team objectives and responsibility for the recruitment processes within the team.
* Take the lead for performance and conduct issues in their clinical research unit.
* Ensure staff are appraised annually, have clear objectives which link to department, care group or corporate objectives and a personal development plan.
* Identify training and development needs of staff in line with unit and institutional objectives and ensure all new staff receive core and departmental induction.
* Ensure performance issues are dealt with in an appropriate and timely manner and follow the relevant disciplinary or capability procedures where formal action is necessary.
* Ensure that satisfactory systems are in place to maintain effective communication within your area and be responsible for ensuring that any communications systems are utilised.
* Observe and continually promote equal opportunities in compliance with the relevant policies on equality, diversity and dignity.
* Keep up to date with relevant statutory research or clinical developments for the management of clinical research ensuring timely and effective implementation of any required changes.
* Educate and update research team about current and forthcoming clinical trials; and lead on the professional and educational development of administrative / operational staff.
* Participate in educational programmes, study days, courses, meetings or conferences as identified in the development plan, and deemed appropriate for their professional development by their line manager.
* Lead on training, induction and orientation of administrative / operational staff in the unit.
* Take a leading role in supporting understanding of the historical and political context in which clinical research has developed and is currently being undertaken.
* Act as an expert resource to staff and consultants / researchers.
* Participate in relevant meetings including study specific, role specific and wider team meetings as required with responsibility for taking and distributing minutes if required.
* Be an expert on the regulatory requirements for conducting clinical trials.
* Act as a champion of the OxCAIR research unit, representing at national and international meetings and conferences as required.
* Contribute to supportive, invigorating, can‑do culture.
Qualifications – Essential Criteria
* Life sciences (or equivalent) degree
* Knowledge of clinical trials, UK Clinical trial regulations, GCP and regulatory framework
* Excellent communication skills and ability to facilitate collaborative working relationships
* Ability to plan and organise a broad range of complex activities; formulate, adjust plans or strategies as required
Qualifications – Desirable Criteria
* Experience of working in a clinical research environment in the NHS
* Experience of working with AI
* Project management training, Well‑developed IT skills/word processing, data collection/internet skills
* Knowledge of developing budgets for clinical trials including AcoRD
* Competence in research orientated PC software (Access, Excel, SPSS, R)
* Experience in managing NIHR grant funding
Personal and behavioural skills – Essential Criteria
* Excellent communication skills and ability to facilitate collaborative working relationships
* Ability to plan and organise a broad range of complex activities; formulate, adjust plans or strategies as required
Personal and behavioural skills – Desirable Criteria
* Project management training, Well‑developed IT skills/word processing, data collection/internet skills
* Knowledge of developing budgets for clinical trials including AcoRD
* Competence in research orientated PC software (Access, Excel, SPSS, R)
* Experience in managing NIHR grant funding
Corporate contribution
Participate in relevant meetings including study specific, role specific and wider team meetings as required with responsibility for taking and distributing minutes if required. Be an expert on the regulatory requirements for conducting clinical trials. Act as a champion of the OxCAIR research unit, representing at national and international meetings and conferences as required. Contribute to supportive, invigorating, can‑do culture.
Subject to Rehabilitation of Offenders Act 1974
This postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.
About Oxford University Hospitals NHS Foundation Trust
Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts in the country. It provides a wide range of general and specialist clinical services and is a base for medical education, training and research. The Trust comprises of four hospitals – the John Radcliffe Hospital, Churchill Hospital and Nuffield Orthopaedic Centre in Headington and the Horton General Hospital in Banbury. Our values, standards and behaviours define the quality of clinical care we offer and the professional relationships we make with our patients, colleagues and the wider community. We call this Delivering Compassionate Excellence and its focus is on our values of compassion, respect, learning, delivery, improvement and excellence. These values put patients at the heart of what we do and underpin the quality healthcare we would like for ourselves or a member of our family. Watch how we set out to deliver compassionate excellence via the OUH YouTube channel.
About the Clinical Artificial Intelligence Research Group
The Clinical Artificial Intelligence Research Group is a multidisciplinary research group based in Oxford University Hospitals NHS Foundation Trust, which currently sits alongside the Emergency Medicine Research Oxford (EMROx) portfolio, and focuses on the evaluation of AI and digital health technologies. It is co‑led by Drs Alex Novak (Emergency Medicine and Ambulatory care) and Sarim Ather (Radiology) and comprises a rapidly expanding team of researchers engaged in a broad portfolio of projects and workstreams, often in partnership with clinical, academic and industrial stakeholders in Oxford, the UK and internationally.
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