Job summary
This is an exciting opportunity to join a diabetes research group with an international reputation for excellence in hypoglycaemia research. The Project Coordinator will work with Professor Simon Heller and Dr Ahmed Iqbal on a randomised controlled trial (RCT) aimed at elucidating the heterogeneity of impaired awareness of hypoglycaemia in type 1 diabetes.
This study is funded by the National Institutes of Health (NIH) which is a major U.S federal government research agency. The RCT will involve state-of-the-art innovations in diabetes care including hybrid closed loop systems and educational interventions. You will work collaboratively with an international consortium of trial centres in the USA, UK and Australia.
This RCT will be the largest study to date on physiological responses to hypoglycaemia and how impaired responses in type 1 diabetes can be improved. It is therefore anticipated that the trial will lead to a number of clinically relevant discoveries and key outcomes.
The post holder will assist in the management of this clinical study and provide support to the clinical trial team. As part of their overall job duties, the successful applicant will work with the Directorate Research and central Clinical Research and Innovation Office (CRIO) teams to enable the Chief or Principal Investigators to complete submissions for regulatory approval for the trial and ensure the study runs in accordance with all applicable regulatory requirements.
Main duties of the job
The post holder will:
- assist in the management of a randomised controlled trial and provide support to the clinical trial team.
- complete submissions for regulatory approval for the trial.
- ensure the study runs in accordance with all applicable regulatory requirements.
- be responsible for the production of study promotional / administrative material.
- answer queries and resolve any technical or administrative barriers to participation.
- liaise with participant identification centres across the North of England and participants to schedule trial visits, including assessing travel and accommodation requirements.
About us
Sheffield Teaching Hospitals NHS Foundation Trust (STHFT) is one of the largest and most successful NHS Foundation Trusts in the UK, and our academic partner the University of Sheffield (UoS) is a world top-100 university striving to solve the world's greatest challenges through teaching and research. STHFT and UoS have large and expanding clinical research portfolio with significant joint Trust-University researchprogrammes, academic directorates, UK and EU Centres of Excellence and extensive collaborations in the UK.
Improving patient care through research and innovation is vital to everything we do, and our dedicated Clinical Research & Innovation Office provides hands-on support and advice to researchers, members of the public, patients and industry partners about getting involved in research, study design and set-up and how our cutting-edge facilities can improve health and healthcare for patients living in Sheffield and beyond.
Sheffield is also host to a number of NIHR infrastructures; the Yorkshire and Humber Clinical Research Network (Y&H CRN), the NIHR Research Design Service for Yorkshire and Humber (NIHR Y&H RDS), the NIHR Devices for Dignity Med-Tech and in-vitro Diagnostics Co-operative (NIHR D4D MIC), a NIHR Experimental Cancer Medicine Centre (NIHR ECMC), a NIHR Clinical Research Facility Experimental Medicine and in 2016 Sheffield was awarded NIHR Biomedical Research Centre (BRC) status, one of 20 nationally.
Job description
Job responsibilities
Please view the attached Job Description and Person Specification documents for full details regarding this post.
When completing your application please ensure that you clearly demonstrate how you meet the role criteria.
You will be working for an organisation which values and respects all of its staff and the community it serves. The Trust is a leader in the NHS and research sectors and provides excellent benefits for its staff. This includes commitments to professional development but also many policies to support employees in balancing their personal and professional lives.
This vacancy is advertised on a fixed term contract basis for a period of 24 months due to the post being externally funded. The fixed term contract status of the post holder will be reviewed in accordance with the Trust's legal obligations regarding fixed term contracts taking into consideration the ongoing source of the external funding and the requirement for the post to be maintained.
Please also note any secondment must first be agreed with your current line manager.
Job description
Job responsibilities
Please view the attached Job Description and Person Specification documents for full details regarding this post.
When completing your application please ensure that you clearly demonstrate how you meet the role criteria.
You will be working for an organisation which values and respects all of its staff and the community it serves. The Trust is a leader in the NHS and research sectors and provides excellent benefits for its staff. This includes commitments to professional development but also many policies to support employees in balancing their personal and professional lives.
This vacancy is advertised on a fixed term contract basis for a period of 24 months due to the post being externally funded. The fixed term contract status of the post holder will be reviewed in accordance with the Trust's legal obligations regarding fixed term contracts taking into consideration the ongoing source of the external funding and the requirement for the post to be maintained.
Please also note any secondment must first be agreed with your current line manager.
Person Specification
Qualifications
Essential
- Educated to degree level in Health/ Biomedical Sciences/ Biology related subject or equivalent experience in a clinical research environment
- Project Management qualification or demonstratable equivalent experience.
Desirable
- Current GCP accreditation
- MSc in Health related/ Biomedical Science/ Biology related subject.
Special Skills and Aptitude
Essential
- Ability to manage a diverse workload and to meet set deadlines on own initiative and without close supervision.
- Ability to produce high quality performance reports for various stakeholders.
- Extensive experience of PC applications such as Excel, Word, PowerPoint, Microsoft Project Manager and Access, using skills at an advanced level of expertise.
- Excellent attention to detail, whilst maintaining the ability to see the bigger picture
- Evidence of report writing and presentation skills.
- Ability to work independently, without supervision and to self-motivate.
- Ability to analyse and communicate to the Directorate Operational Group and Executive Committee complex data from various sources to enable continuous quality and delivery efficiencies.
- Demonstrable self-awareness, an understanding of impact on others and an ability to manage self and maintain professional conduct in difficult and challenging situations.
- Proactive in fulfilling needs of researchers.
Skills and Knowledge
Essential
- Knowledge of research processes and research methods applicable to health setting.
- Knowledge of research legislation including research governance, ICH GCP, Medicines for Human use (Clinical Trials) Regulations, Data Protection, Human Tissue Act, Mental Capacity Act.
- Knowledge of patient and public involvement initiatives.
- Ability to maintain timely, highly complex and accurate information sources and databases
- Excellent organisational skills and an ability to prioritise an unpredictable workload with frequent disruption
- Understanding and commitment to the need for confidentiality.
- Knowledge, experience and maintenance of quality assurance systems.
Desirable
- Knowledge of research funding sources.
Experience
Essential
- Extensive experience of clinical research in the NHS, Academic or commercial environment.
- Experience of project design, management and evaluation.
- Experience of the submission and approval process for set up of clinical trials.
- Extensive experience managing clinical research performance metrics
- Experience of working independently and as part of a team.
- Experience of working collaboratively with internal and external partners.
- Experience of working in a fast paced, adaptable environment.
- Experience of process innovation and other service improvement initiatives.
Desirable
- Experience of developing Standard Operating Procedures, Policies and Procedures.
Physical Requirements
Essential
- Able to work across different NHS Trusts and willingness to travel to hospitals in the UK if required.
- Balance pressures of research demands and deadlines.
Person Specification
Qualifications
Essential
- Educated to degree level in Health/ Biomedical Sciences/ Biology related subject or equivalent experience in a clinical research environment
- Project Management qualification or demonstratable equivalent experience.
Desirable
- Current GCP accreditation
- MSc in Health related/ Biomedical Science/ Biology related subject.
Special Skills and Aptitude
Essential
- Ability to manage a diverse workload and to meet set deadlines on own initiative and without close supervision.
- Ability to produce high quality performance reports for various stakeholders.
- Extensive experience of PC applications such as Excel, Word, PowerPoint, Microsoft Project Manager and Access, using skills at an advanced level of expertise.
- Excellent attention to detail, whilst maintaining the ability to see the bigger picture
- Evidence of report writing and presentation skills.
- Ability to work independently, without supervision and to self-motivate.
- Ability to analyse and communicate to the Directorate Operational Group and Executive Committee complex data from various sources to enable continuous quality and delivery efficiencies.
- Demonstrable self-awareness, an understanding of impact on others and an ability to manage self and maintain professional conduct in difficult and challenging situations.
- Proactive in fulfilling needs of researchers.
Skills and Knowledge
Essential
- Knowledge of research processes and research methods applicable to health setting.
- Knowledge of research legislation including research governance, ICH GCP, Medicines for Human use (Clinical Trials) Regulations, Data Protection, Human Tissue Act, Mental Capacity Act.
- Knowledge of patient and public involvement initiatives.
- Ability to maintain timely, highly complex and accurate information sources and databases
- Excellent organisational skills and an ability to prioritise an unpredictable workload with frequent disruption
- Understanding and commitment to the need for confidentiality.
- Knowledge, experience and maintenance of quality assurance systems.
Desirable
- Knowledge of research funding sources.
Experience
Essential
- Extensive experience of clinical research in the NHS, Academic or commercial environment.
- Experience of project design, management and evaluation.
- Experience of the submission and approval process for set up of clinical trials.
- Extensive experience managing clinical research performance metrics
- Experience of working independently and as part of a team.
- Experience of working collaboratively with internal and external partners.
- Experience of working in a fast paced, adaptable environment.
- Experience of process innovation and other service improvement initiatives.
Desirable
- Experience of developing Standard Operating Procedures, Policies and Procedures.
Physical Requirements
Essential
- Able to work across different NHS Trusts and willingness to travel to hospitals in the UK if required.
- Balance pressures of research demands and deadlines.
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
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).
