Student Experience Diversity and Inclusion Officer - Sheffield, United Kingdom - Wales Medicines Strategy Group

Description

Employer Sheffield Children's NHS Foundation Trust Employer type NHS Site Sheffield Children's NHS Foundation Trust Town Sheffield Salary £35,392 - £42,618 per annum pro rata Salary period Yearly Closing 16/05/2024 23:59
Research Sponsorship Officer


NHS AfC:
Band 6

The Research Sponsorship Officer will have a responsibility to ensure that all research is conducted in accordance with the Trust's sponsorship requirements, current legislation, national guidelines and Trust policies across all study sites including providing advice and guidance to investigators with administrative planning as appropriate.

The post holder will guide compliance with the Trust policies for Research Governance as well as UK Policy Framework for Health and Social Care Research.

With an increasing number of studies being managed by Sheffield Children's NHS Foundation Trust, the post holder will be responsible for the management of a growing portfolio of Trust sponsored trials and be the lead sponsor contact for Trust trials ensuring they are conducted in accordance with current legislation, ensuring all activities are compliant.

This role will have a responsibility to ensure that all research is conducted in accordance with the Trust's sponsorship requirements, current legislation, national guidelines and Trust policies across all study sites including providing advice and guidance to investigators with administrative planning as appropriate.

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.

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 trial

Sheffield Children's is one of three independent, specialist paediatric hospitals in the country, providing dedicated healthcare for children and young people across community, mental health and acute specialist settings.

We have three overarching aims that set the direction for the Trust in our vision "to create a healthier future for children and young people.

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Leader in children's health

generous annual leave entitlement and pension scheme and access to salary sacrifice schemes such as cycle to work and lease cars.

We are committed to supporting colleagues from different heritages and lifestyles while at work.

This is supported through the offer we have in place for flexible working and the three equality network groups we have in place.

Colleagues are encouraged to join these groups and request flexible working.

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.

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.

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).

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.

Day to day management of junior staff.
Contributing to as required, the development of clinical and research policies / procedures / SOPs.
Managing workload effectively and in accordance with guidance relating to Research Governance.
Providing research governance expertise to team members as and when 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 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
• 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 offer encouragement and active support to applicants with additional needs, including those from ethnic minorities, with disabilities and members of the LGBTQ+ community.

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.

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:
Respect – value differences, tackling inequality and fostering a culture of inclusion
Excellence – delivering a high-quality standard of care
Qualifications and Training
First degree in biomedical / scientific discipline or equivalent experience
Project Management Qualification

Previous experience of working in a research support environment and/or understanding of NHS R&D environment, Sponsorship, research funding systems, managing clinical trials and clinical trial methodology and logistics.

Experience in a governance or a research role
Excellent knowledge of Microsoft Office (Word, Excel, PowerPoint) and using them to produce written formal reports with quality presentation skills
Experience of managing multiple projects / assignments independently and as a team
Project Management
Proven record of planning, organisational, change management and administration skills
Positive and flexible approach to work

Name Keith Pugh Job title Research & Development Manager Email address Telephone number Additional information Keith works in a hyrbid fashion , therefore please contact him via email first and a discussion about the role can arranged if necessary.

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