The University of Sheffield is a remarkable place to work. Our people are at the heart of everything we do. Their diverse backgrounds, abilities and beliefs make Sheffield a world-class university.
We offer a fantastic range of benefits including a highly competitive annual leave entitlement (with the ability to purchase more), a generous pensions scheme, flexible working opportunities, a commitment to your development and wellbeing, a wide range of retail discounts, and much more. Find out more about our benefits (opens in a new window) and join us to become part of something special.
You will work closely with Sheffield Clinical Trials Research Unit (CTRU) staff and with the study Chief Investigator(s) to conduct research, coordinate and deliver one or more multi-site research studies. You will work closely with other members of the study team (e.g. the Chief Investigator, statisticians and data managers) to ensure the implementation of all aspects of studies, including obtaining regulatory approvals, recruiting sites, supporting participant recruitment and final report writing. You may also supervise staff at study sites and undertake quality control responsibilities related to studies including site monitoring.
Previous experience in the management and coordination of large multicentre trials is essential
Main duties and responsibilities
Working under the supervision of a Senior Research Fellow, you will be responsible for coordinating all aspects of studies, including:
Establishing study procedures and processes and ensuring participating centres have the appropriate documentation, information and training to comply with these. This includes protocol development, obtaining ethics and regulatory approval and the establishment of governance arrangements (e.g. Advisory, Project Management Committees).
Implementation of research studies in accordance with protocols and across multiple sites. This includes recruiting and liaising with NHS and social care sites; training and supervising trial staff at sites to ensure the effective running of the study protocol.
Ensuring the timely recruitment of trial participants with secure randomisation processes and subsequent efficient and effective data management.
Data collection and reporting, including supervision and co-ordination of other researchers where appropriate.
Ensuring compliance with research ethics, clinical governance and data protection and good clinical practice requirements.
Liaison with clinicians, research collaborators, and with members of the study team to ensure completion of the health economic evaluation.
Liaison with statisticians to ensure statistical analysis is undertaken.
Provision of regular and ad hoc information, both written and verbal, to the trial participants, collaborators and funders, to include reports, updates, guidance, newsletters and website, ensuring that these meet legislative, contractual and ethical requirements.
Reading relevant academic papers to update knowledge of current research areas.
Coordination of the trial team's input to the final report and all trial publications for academic journals, as well as providing input to the preparation of papers.
Travel to sites around the UK to undertake study site monitoring.
Acting as the point of contact for all external and internal agencies.
Oversight of the creation and maintenance of all trial files, Including the trial master file, and overview of site files.
May be responsible for the supervision of study-specific staff.
Any other duties, commensurate with the grade of the post.
Planning and Organising
The overall efficient day-to-day management of the trial.
Plan work to assist delivery of studies within agreed timescales.
Prioritise tasks to ensure allocation of time to different studies as appropriate to demands.
Oversee work of study staff where relevant.
Ensure reliability of the data by collaboration with the CTRU data management team.
Advance planning to meet deadlines for formal project monitoring and study milestones (e.g. participant recruitment, data collection and data analysis).
Advance planning to meet deadlines for dissemination e.g. reports and papers.
Develop agendas and materials for research project meetings.
Managing and monitoring the study budgets.
Person Specification
Our diverse community of staff and students recognises the unique abilities, backgrounds, and beliefs of all. We foster a culture where everyone feels they belong and is respected. Even if your past experience doesn't match perfectly with this role's criteria, your contribution is valuable, and we encourage you to apply. Please ensure that you reference the application criteria in the application statement when you apply.
Essential criteria
- Undergraduate qualification in science, social science, psychology or health care or equivalent experience. (Interview/Application)
- Experience of undertaking a range of health-related research methods, e.g. qualitative methods and systematic searching and appraisal of scientific literature. (Interview/Application)
- Experience coordinating the central delivery of an National Institute for Health Research (NIHR) funded multi-centre clinical trial to Standard Operating Procedures (SOPs) in a UK Clinical Research Collaboration-registered trials unit, ideally in a CTIMP trial. (Interview/Application)
- Sound understanding of the scientific principles and methodology relating to the implementation of randomised controlled trials. (Interview/Application)
- Experience of working with a multidisciplinary team, including clinicians and patient representatives in a research capacity. (Interview/Application)
- Experience of training clinical trial site staff working on a clinical trial, including where they may be new to research. (Interview/Application)
- Experience of liaising with Trial Steering Committees and/or Data Monitoring and Ethics Committees to ensure compliance with Research Governance, Data Protection and Ethical Requirements. (Interview/Application)
- Experience of report writing, e.g. progress reports to funders, safety reports to regulatory bodies and final reports or academic publications. (Interview/Application)
- Experience using the Integrated Research Application System (IRAS) or other equivalent systems. (Interview/Application)
- Experience of site monitoring, in-person and/or remotely, including how this is informed by statutory instruments, the NHS, the Department of Health and Social Care, Good Clinical Practice quality standards and GDPR. (Interview/Application)
- Excellent interpersonal and communication skills necessary to develop and maintain effective working relationships with colleagues within the University and externally, with researchers, clinicians and members of the public involved in the studies. (Interview/Application)
Desirable criteria
- Postgraduate qualification including an element of research, or equivalent experience. (Interview/Application)
Further Information
Grade: 7 - £37,999-£42,632
Duration: Fixed-term for 12 months.
Line manager: Research Fellow
Direct reports: N/A
For informal enquiries about this job contact Rebecca Swift, Recruiter: on r.d.swift@sheffield.ac.uk or on 0114 222 2988.
Next steps in the recruitment process
It is anticipated that the selection process will take place on the week beginning the 3rd February 2025. This will consist of an interview. We plan to let candidates know if they have progressed to the selection stage on the week commencing 27th January 2025. If you need any support, equipment, or adjustments to enable you to participate in any element of the recruitment process you can contact Rebecca Swift on r.d.swift@sheffield.ac.uk
Our vision and strategic plan
We are the University of Sheffield. This is our vision: sheffield.ac.uk/vision (opens in new window).
What we offer
- A minimum of 41 days annual leave including bank holiday and closure days (pro rata) with the ability to purchase more.
- Flexible working opportunities, including hybrid working for some roles.
- Generous pension scheme.
- A wide range of discounts and rewards on shopping, eating out and travel.
- A variety of staff networks, providing opportunities for social interaction, peer support and personal development (for example, Race Equality, LGBT+, Women's and Parent's networks).
- Recognition Awards to reward staff who go above and beyond in their role.
- A commitment to your development access to learning and mentoring schemes; integrated with our Academic Career Pathways.
- A range of generous family-friendly policies
- paid time off for parenting and caring emergencies
- support for those going through the menopause
- paid time off and support for fertility treatment
- and more
More details can be found on our benefits page: sheffield.ac.uk/jobs/benefits (opens in a new window).
We are a Disability Confident Employer. If you have a disability and meet the essential criteria for this job you will be invited to take part in the next stage of the selection process.
We are a research university with a global reputation for excellence. Our ideas and expertise change the world for the better, making a real difference to society. We know that when people come together with different views, approaches and insights it can lead to richer, more creative and innovative teaching and research and the highest levels of student experience. Our University Vision ( www.sheffield.ac.uk/vision ) outlines our commitment to building a diverse community of staff and students that recognises and values the abilities, backgrounds, beliefs and ways of living for everyone.