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Detailed job description and main responsibilities

Sponsorship and Research Management:

• To contribute to the development and management of systems and procedures for the co-ordination of clinical research within the Trust with all those working within research
• Communicating effectively with the clinicians and research teams providing clinical trials support and guidance to ensure best practice is achieved.
• Communicating with Ethical Committees and other regulatory authorities such as the HRA and MHRA.
• Liaising with all staff involved in research (Consultants and junior medical staff, project managers, research nurses and other nursing staff, central laboratories, Clinical Trials Unites, Clinical Research Organisations etc). This will involve attendance at project related meetings, investigator meetings (as necessary) to provide guidance and advice on the relevant information to the study team.
• Perform sponsorship reviews of IRAS applications and associated documents for new studies and amendments.
• Providing guidance and support to researchers to determine which approvals are needed for studies.
• Oversee the maintenance of research management system (EDGE) for the sponsored study portfolio.
• Ensuring compliance with regulatory requirements by implementing appropriate audit and monitoring systems and performing risk assessments for each study.
• Implementation of appropriate pharmacovigilance / adverse event reporting systems in compliance with EU and national regulations.
• Maintaining trial documentation in accordance with the ICH-GCP and the EU Clinical Trials Directive 2004 i.e., protocols, study files, investigator brochure etc.
• Working with the University and other research sponsorship teams, to ensure that research governance regulations are applied consistently across organisational boundaries.
• To identify and refer any major concerns on research governance and sponsorship issues to the Research & Development Manager
• To support the Research & Development Team in the preparations and conduct of any inspection of the Trust’s research.
• To manage, in conjunction with other members of the R&D team, a robust file management system for paper-based and electronic files for matters concerning the administration of research projects.
• Ensuring research studies are costed appropriately to ensure that they are being delivered within budget.
• Supporting the collection of clinical research data by designing tools (forms) for data collections and distribution procedures to ensure smooth running of the trial / study.
• Performing miscellaneous job-related duties as assigned, including preparing co-ordinating research / trials related meetings with clinical members of the team i.e Research Nurse teams, Trial Management Groups, Trial Steering Committees, sponsorship meetings, Research Governance and Sponsorship committees and Data Monitoring Committees.
• Co-ordinating the completion of electronic trials documentation for new trials, involving facilitating applications for Ionising Radiation (Medical Physics) Regulations (IRMER) for imaging investigations and for nuclear medicine through the Administration of Radiation Substances Advisory Committee (ARSAC).
• Producing regular trial updates as required.
• Liaising with participating sites, ensuring all work is appropriately contracted and study protocols are complied with.
• Ensuring site initiation, randomisation and site pharmacovigilance are in place where required.
• Provide assurance to the Research Governance & Sponsorship Committee and other committees as required.
• Where required perform monitoring and audit on Trust Sponsored research studies.
• To have a robust knowledge of Information Governance and ensure adherence to applicable legislation and Trust Policies in the conduct of the Trust’s Sponsored studies.
• Working with the Research & Development Manger to ensure that all required legal contracts are in place for the effective and robust delivery of Trust Sponsored trials.

Management

• Day to day management of junior staff.
• Contributing to as required, the development of clinical and research policies / procedures / SOPs.
• Resolving delays and difficulties with activating trials, developing, and managing an escalation process to be followed when trial initiation problems / delays arise.
• Managing workload effectively and in accordance with guidance relating to Research Governance.
• Attending meetings relevant to the nature of the role.
• Providing research governance expertise to team members as and when required.
• Deputise for the R&D Manager where required

Training and Professional Development

•    Maintaining professional development whilst evaluating own specialist knowledge and through a process of appraisal and personal development planning.
•    Participating in Trust-wide education programmes.
•    Participating in research seminars to keep up to date with research.
•    Maintaining knowledge on clinical trials including informal learning and attendance at appropriate national training initiatives.
•    Networking with local, national, and international colleagues in research.
•    Developing and providing training on research within the NHS to other staff, University students, academic supervisors etc.
•    Developing and providing training on portfolio adoption and amendments to project managers and trial co-ordinators
•    Undertaking any other duties consistent with the responsibilities of the grade and needs of the service

Inclusive Recruitment & Selection

We are committed to being an inclusive employer and accurate data capture is an important part of that to ensure we are supportive and representative. Our aim is to ensure that all applicants can see themselves in the available categories on our application form, but we recognise that some of our data capture fields are not inclusive. We have flagged this with our system provider to ask for change.

We offer encouragement and active support to applicants with additional needs, including those from ethnic minorities, with disabilities and members of the LGBTQ+ community. If you wish to adjust any aspect of the recruitment process or wish to find out more about our recruitment & selection processes, please get in touch with our Recruitment Manager: [email protected]

We are continually reviewing our recruitment & selection process to support the long-term aim of Sheffield Children’s being a champion of Equality, Diversity, and Inclusion. If you have any ideas for improvement, please get in touch with Catherine Gilbert at [email protected]

Trust Values

The Trust is committed to providing great quality patient care and keep children, young people and families at the heart of what we do by following our CARE values:

• Compassion – leading by kindness and showing empathy, understanding and respect
• Accountability – striving to do the right thing and owning responsibility
• Respect – value differences, tackling inequality and fostering a culture of inclusion
• Excellence – delivering a high-quality standard of care