Job summary
You will be a member of the Research Governance Team within the Directorate of Research & Innovation team and will be responsible for supporting Investigators and the Clinical Research Facility Delivery Team with the set-up, ongoing management and close out of clinical research projects hosted and sponsored by the Trust.
This includes the preparation of documents to be submitted to Regulatory Authorities including the Health Research Authority (HRA), Research Ethics Committee (REC), and Medicines and Healthcare products Regulatory Agency (MHRA). In accordance with the applicable Regulations and legislation as well as Trust Standard Operating Procedures (SOPs) and Policies, you will work with internal colleagues and external partners to ensure timely confirmation of capacity and capability for studies hosted and led by the Trust. You will also support the Trust in its preparation for Regulatory Inspection.
The post will be based predominantly within the Directorate of Research & Innovation at Sheffield Children's Hospital but there may a requirement to work across Trust sites. We will provide excellent opportunities for development and you will have the opportunity to attend training and meetings in the field of clinical research. In return, we are seeking enthusiastic and motivated candidates who have experience of and an interest in developing a career in clinical research.
Main duties of the job
You will have a good working knowledge of computer software packages and excellent word processing skills. You must have the proven ability to prioritise your workload and produce high standard, accurate work to tight deadlines. You must have excellent communication skills through face-to-face interactions and using virtual platforms. You will be expected to develop strong working relationships with Investigators and their research teams, support service personnel and external stakeholders to ensure the effective management of research projects and clinical trials running in the Trust.
You will also have a track record of integrating with teams; be aware of Good Clinical Practice (GCP) and the UK Policy Framework for Health and Social Care Research; be able to demonstrate awareness of your own limitations and be willing to work flexibly in terms of hours and duties to meet service needs. You will be expected to develop specialised skills and knowledge relating to the projects you support.
You will be required to adopt a flexible and proactive working pattern and work autonomously.
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 healt
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
R&D Approval Process
- To provide advice to investigators and their research staff on the regulatory and Research and Development (R&D) registration, approval and delivery requirements for research and clinical trials.
- To contribute to ensuring the smooth processing of performance management of research projects each month by registering them fully and accurately into the research database.
- To support other members of the R&D team in ensuring all governance requirements including the requirements of The Medicines for Human Use (Clinical Trials) Regulations, UK Policy Framework for Health and Social Care Research and Good Clinical Practice are satisfied before a new research project or clinical trial can commence.
- To communicate with finance, pharmacy other internal support departments to ensure rapid review of Organisational Information Documents, Schedule of Events and/or SoECAT forms where appropriate and approval of new research proposals to provide prompt confirmation of capacity and capability.
- To process and implement study amendments using the HRA amendment tool.
- To have up-to-date knowledge of internal and external policies that impact on research and clinical trials.
Other Administration
- To act as a point of control for the R&D Office Research Passport system.
- To act as primary point of contact for studies and trials being hosted and sponsored by the Trust, maintaining and updating essential documents in the R&D site files.
- To be involved in the local costing process of commercially sponsored and funded clinical trials.
- To contribute to the maintenance of information systems for monitoring the progress through the lifetime of the projects in accordance with national, regional and local performance management and reporting.
- To contribute to the closeout and archiving of completed studies.
- To participate in decision making within the R&D team and to take action as appropriate.
- To adhere to national and local quality standards, recommendations and guidelines from national reports.
Communication
- To be a point of contact for queries from staff, external bodies or the public relating all studies sponsored or hosted by the Trust.
- To be a point of advice for queries relating to the R&D approval process ensuring they are dealt with appropriately.
- To keep appropriate staff informed of the progress of studies and escalate non-conformances and instances of underperformance against milestones and metrics within studies.
- The post holder will deal with telephone enquiries from investigators, research teams and stakeholders, ensuring that appropriate personnel are informed in order for actions to be undertaken.
General
- To organize research meetings and training as required.
- To provide administrative support in all preparatory work for audits and regulatory inspections including the maintenance and review of R&I Standard Operating Procedures
- To support audits of studies hosted and/or sponsor by the Trust.
- To provide support for R&D colleagues in their absence.
- To ensure that current and approved versions of essential documents are available and in use by investigators and their research teams.
Education and Training
- To act as a resource for colleagues in relation to clinical trials and research studies.
- To contribute to the production of guidance materials for investigators and research teams.
- To attend local, regional and national meetings in relation to clinical studies as appropriate and as agreed with line manager.
- To be responsible for maintaining own professional development and be aware of current practices and future developments within the Trust and NHS.
Freedom to act
- Is guided by good practice and established precedents and understands what results or standards are to be achieved.
- Works independently and sets own priorities, seeking advice as necessary.
Knowledge
- In depth knowledge of Microsoft applications used by the Trust (including Word, Excel, Outlook, Microsoft Teams), and knowledge of EDGE and IRAS systems.
- Understanding of clinical trials and clinical research in an NHS setting
- Knowledge of Good Clinical Practice (GCP) and Data Protection.
Skills
- Excellent communication skills, both oral and written.
- Ability to have effective communications with colleagues and stakeholders in face-to-face interactions and using virtual platforms.
- Ability to work unsupervised and on own initiative.
- Has tact and sensitivity.
- Exercises judgement in planning and prioritising own workload to meet deadlines.
- Provides and receives complex and sensitive information.
- Maintains confidentiality and follows the EU Directive on Good Clinical Practice, The Medicines for Human Use (Clinical Trials) Regulations and other regulatory, legislative and good practice guidelines.
- Requirement to seek and interpret information, make judgements about the type and form of information needed in research and clinical trials work.
- Works in an efficient, effective and timely manner and is adaptable to change.
Information Governance
All staff have an individual responsibility for creating accurate records of their work and for making entries into and managing all NHS records effectively in line with the Health Record Keeping Policy and other Health Records and Corporate Records Management policies and procedures in order to meet the Trusts legal, regulatory and accountability requirements. All staff must comply to Data Protection law as set out in the Data Protection Act 2018.
Health and Safety
- To take reasonable care to prevent injury to themselves or others who may be affected by their acts or omissions.
- To co-operate fully in discharging the Trust policies and procedures with regard to health and safety matters.
- To immediately report to their manager any shortcomings in health and safety procedures and practice.
- To report any accidents or dangerous incidents to their immediate manager and safety representative as early as possible and submit a completed accident/incident form.
- Whilst the aim of the Trust is to promote a co-operative and constructive view of health and safety concerns in the organisation, all staff must be aware that a wilful or irresponsible disregard for safety matters may give rise to disciplinary proceedings.
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
R&D Approval Process
- To provide advice to investigators and their research staff on the regulatory and Research and Development (R&D) registration, approval and delivery requirements for research and clinical trials.
- To contribute to ensuring the smooth processing of performance management of research projects each month by registering them fully and accurately into the research database.
- To support other members of the R&D team in ensuring all governance requirements including the requirements of The Medicines for Human Use (Clinical Trials) Regulations, UK Policy Framework for Health and Social Care Research and Good Clinical Practice are satisfied before a new research project or clinical trial can commence.
- To communicate with finance, pharmacy other internal support departments to ensure rapid review of Organisational Information Documents, Schedule of Events and/or SoECAT forms where appropriate and approval of new research proposals to provide prompt confirmation of capacity and capability.
- To process and implement study amendments using the HRA amendment tool.
- To have up-to-date knowledge of internal and external policies that impact on research and clinical trials.
Other Administration
- To act as a point of control for the R&D Office Research Passport system.
- To act as primary point of contact for studies and trials being hosted and sponsored by the Trust, maintaining and updating essential documents in the R&D site files.
- To be involved in the local costing process of commercially sponsored and funded clinical trials.
- To contribute to the maintenance of information systems for monitoring the progress through the lifetime of the projects in accordance with national, regional and local performance management and reporting.
- To contribute to the closeout and archiving of completed studies.
- To participate in decision making within the R&D team and to take action as appropriate.
- To adhere to national and local quality standards, recommendations and guidelines from national reports.
Communication
- To be a point of contact for queries from staff, external bodies or the public relating all studies sponsored or hosted by the Trust.
- To be a point of advice for queries relating to the R&D approval process ensuring they are dealt with appropriately.
- To keep appropriate staff informed of the progress of studies and escalate non-conformances and instances of underperformance against milestones and metrics within studies.
- The post holder will deal with telephone enquiries from investigators, research teams and stakeholders, ensuring that appropriate personnel are informed in order for actions to be undertaken.
General
- To organize research meetings and training as required.
- To provide administrative support in all preparatory work for audits and regulatory inspections including the maintenance and review of R&I Standard Operating Procedures
- To support audits of studies hosted and/or sponsor by the Trust.
- To provide support for R&D colleagues in their absence.
- To ensure that current and approved versions of essential documents are available and in use by investigators and their research teams.
Education and Training
- To act as a resource for colleagues in relation to clinical trials and research studies.
- To contribute to the production of guidance materials for investigators and research teams.
- To attend local, regional and national meetings in relation to clinical studies as appropriate and as agreed with line manager.
- To be responsible for maintaining own professional development and be aware of current practices and future developments within the Trust and NHS.
Freedom to act
- Is guided by good practice and established precedents and understands what results or standards are to be achieved.
- Works independently and sets own priorities, seeking advice as necessary.
Knowledge
- In depth knowledge of Microsoft applications used by the Trust (including Word, Excel, Outlook, Microsoft Teams), and knowledge of EDGE and IRAS systems.
- Understanding of clinical trials and clinical research in an NHS setting
- Knowledge of Good Clinical Practice (GCP) and Data Protection.
Skills
- Excellent communication skills, both oral and written.
- Ability to have effective communications with colleagues and stakeholders in face-to-face interactions and using virtual platforms.
- Ability to work unsupervised and on own initiative.
- Has tact and sensitivity.
- Exercises judgement in planning and prioritising own workload to meet deadlines.
- Provides and receives complex and sensitive information.
- Maintains confidentiality and follows the EU Directive on Good Clinical Practice, The Medicines for Human Use (Clinical Trials) Regulations and other regulatory, legislative and good practice guidelines.
- Requirement to seek and interpret information, make judgements about the type and form of information needed in research and clinical trials work.
- Works in an efficient, effective and timely manner and is adaptable to change.
Information Governance
All staff have an individual responsibility for creating accurate records of their work and for making entries into and managing all NHS records effectively in line with the Health Record Keeping Policy and other Health Records and Corporate Records Management policies and procedures in order to meet the Trusts legal, regulatory and accountability requirements. All staff must comply to Data Protection law as set out in the Data Protection Act 2018.
Health and Safety
- To take reasonable care to prevent injury to themselves or others who may be affected by their acts or omissions.
- To co-operate fully in discharging the Trust policies and procedures with regard to health and safety matters.
- To immediately report to their manager any shortcomings in health and safety procedures and practice.
- To report any accidents or dangerous incidents to their immediate manager and safety representative as early as possible and submit a completed accident/incident form.
- Whilst the aim of the Trust is to promote a co-operative and constructive view of health and safety concerns in the organisation, all staff must be aware that a wilful or irresponsible disregard for safety matters may give rise to disciplinary proceedings.
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
Essential
- Degree in health/research related subject or substantial relevant experience
- Comprehensive IT skills including: Outlook, WORD, Excel, Access, Powerpoint, Internet or comparable computer packages
- Required to participate in ongoing Professional and Personal Development and undertake additional training as required
Desirable
- Evidence of appropriate further education/development
- Experience of working in R&D in NHS or Academia
- Research qualification
- IT Qualification e.g. ECDL
- Administrative qualifications
- Experience of working with EDGE and IRAS
Experience and Knowledge and Skills
Essential
- Comprehensive administrative/data management experience - preferably in an NHS setting or a busy office environment
- Experience in a working environment that involves patient/customer care
- Knowledge of clinical trials
- Knowledge of research governance and regulations (e.g. ICH-GCP and EU Directives)
- Recent project/ research/ data collection or clinical audit experience
- Clear understanding of the importance of confidentiality
- Experience of communication with a wide variety of people
- Confident handling large bodies of complex information
- Ability to translate information between formats with a high level of accuracy
- Able to produce clear written or verbal reports, instructions and advice
Desirable
- Experience of working in a NHS setting
- Experience of working within a clinical trial setting
- Experience of working in a paediatric environment
- Knowledge of research methodologies
- Knowledge of Research funding streams and mechanisms
- Knowledge of writing and reviewing SOPs
Personal Attributes
Essential
- Excellent communication and interpersonal skills, both written and verbal, in order to undertake own job and inform work colleagues, external bodies, and various hospital departments
- Able to display empathy, tact, reassurance and diplomacy when receiving and providing information. (This is occasionally complex and sensitive confidential information)
- Able to work successfully on a range of different tasks at any one time
- Ability and experience of working as part of a team
- Must be able to work with minimal supervision
- Flexible and proactive approach, creative thinker
Demonstrates Trust Values
Essential
- Compassion, Excellence, Accountability, Respect- Together we care
Person Specification
Qualifications
Essential
- Degree in health/research related subject or substantial relevant experience
- Comprehensive IT skills including: Outlook, WORD, Excel, Access, Powerpoint, Internet or comparable computer packages
- Required to participate in ongoing Professional and Personal Development and undertake additional training as required
Desirable
- Evidence of appropriate further education/development
- Experience of working in R&D in NHS or Academia
- Research qualification
- IT Qualification e.g. ECDL
- Administrative qualifications
- Experience of working with EDGE and IRAS
Experience and Knowledge and Skills
Essential
- Comprehensive administrative/data management experience - preferably in an NHS setting or a busy office environment
- Experience in a working environment that involves patient/customer care
- Knowledge of clinical trials
- Knowledge of research governance and regulations (e.g. ICH-GCP and EU Directives)
- Recent project/ research/ data collection or clinical audit experience
- Clear understanding of the importance of confidentiality
- Experience of communication with a wide variety of people
- Confident handling large bodies of complex information
- Ability to translate information between formats with a high level of accuracy
- Able to produce clear written or verbal reports, instructions and advice
Desirable
- Experience of working in a NHS setting
- Experience of working within a clinical trial setting
- Experience of working in a paediatric environment
- Knowledge of research methodologies
- Knowledge of Research funding streams and mechanisms
- Knowledge of writing and reviewing SOPs
Personal Attributes
Essential
- Excellent communication and interpersonal skills, both written and verbal, in order to undertake own job and inform work colleagues, external bodies, and various hospital departments
- Able to display empathy, tact, reassurance and diplomacy when receiving and providing information. (This is occasionally complex and sensitive confidential information)
- Able to work successfully on a range of different tasks at any one time
- Ability and experience of working as part of a team
- Must be able to work with minimal supervision
- Flexible and proactive approach, creative thinker
Demonstrates Trust Values
Essential
- Compassion, Excellence, Accountability, Respect- Together we care
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).
