Research Sponsorship Officer

7 months ago

Sheffield, United Kingdom Sheffield Children’s NHS Foundation Trust Full time

**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.

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 Trusts 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.

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 Trusts 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.

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