Job summary
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.
Main duties of the job
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. Further duties include:
- 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
About us
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."
- Outstanding patient care
- Brilliant place to work
- Leader in children's health
Our commitment to rewarding colleagues is demonstrated through our brilliant reward and benefits offer including; 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.
Job description
Job 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 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.
- 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 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. 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: Catherine.Gilbert7@nhs.net
We are continually reviewing our recruitment & selection process to support the long-term aim of Sheffield Childrens being a champion of Equality, Diversity, and Inclusion. If you have any ideas for improvement, please get in touch with Catherine Gilbert at Catherine.Gilbert7@nhs.net
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
Job description
Job 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 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.
- 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 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. 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: Catherine.Gilbert7@nhs.net
We are continually reviewing our recruitment & selection process to support the long-term aim of Sheffield Childrens being a champion of Equality, Diversity, and Inclusion. If you have any ideas for improvement, please get in touch with Catherine Gilbert at Catherine.Gilbert7@nhs.net
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
Person Specification
Qualifications and Training
Essential
- First degree in biomedical / scientific discipline or equivalent experience
- Management qualification, or equivalent Experience
- ICH-GCP qualification
Desirable
- Postgraduate qualification
- Project Management Qualification
Experience
Essential
- 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.
- Managerial experience in an administration environment
- 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
- Advanced decision making skills and ability to resolve complex work-related issues.
Desirable
- Project Management
- Experience of working in the NHS
- Experience in a customer facing role
- Experience of managing a team
Personal Attributes
Essential
- Proven record of planning, organisational, change management and administration skills
- Excellent level of verbal and written communication with the ability to persuade, negotiate and influence others.
- Able to use judgement and initiative to provide information and support.
- Excellent numerical and analytical skills with excellent attention to detail and accuracy
- Empathetic approach to managing and resolving enquiries.
- Able to manage difficult and distressing situations effectively.
- Able to collaborate with others.
- Positive and flexible approach to work
- Understands limits of own responsibilities
Person Specification
Qualifications and Training
Essential
- First degree in biomedical / scientific discipline or equivalent experience
- Management qualification, or equivalent Experience
- ICH-GCP qualification
Desirable
- Postgraduate qualification
- Project Management Qualification
Experience
Essential
- 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.
- Managerial experience in an administration environment
- 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
- Advanced decision making skills and ability to resolve complex work-related issues.
Desirable
- Project Management
- Experience of working in the NHS
- Experience in a customer facing role
- Experience of managing a team
Personal Attributes
Essential
- Proven record of planning, organisational, change management and administration skills
- Excellent level of verbal and written communication with the ability to persuade, negotiate and influence others.
- Able to use judgement and initiative to provide information and support.
- Excellent numerical and analytical skills with excellent attention to detail and accuracy
- Empathetic approach to managing and resolving enquiries.
- Able to manage difficult and distressing situations effectively.
- Able to collaborate with others.
- Positive and flexible approach to work
- Understands limits of own responsibilities
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
