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Job overview University Hospitals of Leicester NHS Trust is seeking a motivated and organised Clinical Trials Coordinator to join the Trauma & Orthopaedics Research Team. This is an exciting opportunity to support the delivery of a diverse and growing portfolio of clinical trials and research studies across Trauma & Orthopaedics at Leicester Royal Infirmary and Leicester General Hospital. The post holder will work closely with Consultant Investigators, research teams, R&D colleagues and external sponsors to ensure studies are set up, coordinated and delivered in line with Good Clinical Practice (GCP), regulatory requirements and Trust governance standard Advert The post holder will coordinate and support the set-up, delivery and management of a portfolio of Trauma & Orthopaedics clinical trials and research studies, ensuring projects are delivered to time, target and in full compliance with Good Clinical Practice (GCP) and research governance requirements. This includes supporting feasibility assessments and regulatory submissions, identifying and screening potential participants in collaboration with clinical teams, and providing clear written and verbal information to patients considering participation in research. The role involves maintaining accurate and timely data collection, completion of case report forms, and upkeep of essential study documentation and site files in accordance with regulatory standards. The post holder will monitor study progress against agreed milestones, identify risks to recruitment or delivery and escalate issues appropriately, working closely with Consultant Investigators, research teams and external sponsors. They will liaise with internal departments such as pharmacy, radiology and laboratories to coordinate protocol requirements, contribute to the preparation of reports and recruitment data, maintain research databases, support training of site staff in study procedures, and contribute to continuous quality improvement and development of standard operating procedures within the research team. Working for our organisation University Hospitals of Leicester NHS Trust is one of the largest and busiest teaching hospital trusts in the country, serving a diverse population across Leicester, Leicestershire and Rutland. As a leading research-active organisation, UHL is committed to delivering “Caring at its best” and advancing evidence-based practice through innovation, collaboration and academic partnership. Joining the Trauma & Orthopaedics Research Team offers the opportunity to work alongside experienced clinicians, researchers and multidisciplinary teams within a supportive environment that values professional development, continuous improvement and high-quality patient care. Detailed job description and main responsibilities The Clinical Trials Coordinator will support the delivery of a diverse portfolio of Trauma & Orthopaedics research studies across University Hospitals of Leicester NHS Trust. The post holder will be responsible for coordinating study set-up, managing ongoing study activity and ensuring research is conducted in accordance with Good Clinical Practice (GCP), UK research governance frameworks and Trust policies. The role involves working collaboratively with Consultant Investigators, research nurses, trial coordinators, R&D teams and external sponsors to ensure studies are delivered safely, efficiently and to agreed recruitment targets. The post holder will contribute to feasibility assessments for new studies, assist with regulatory submissions and amendments, and support the timely activation of trials. A key element of the role is identifying and screening potential participants in partnership with clinical teams, ensuring accurate eligibility assessment and maintaining clear communication with patients who are considering participation in research. The post holder will provide study information in line with ethical approvals and support informed consent processes where delegated and appropriately trained. The Clinical Trials Coordinator will be responsible for accurate and timely data collection and entry, completion of case report forms, maintenance of Investigator Site Files and Trial Master Files, and resolution of data queries. They will monitor study progress against agreed milestones, identify potential risks to recruitment or delivery, and escalate concerns appropriately to senior research colleagues. The role requires close liaison with internal departments including pharmacy, radiology, laboratories and finance teams to ensure protocol requirements are met. The post holder will also contribute to preparation of recruitment reports, presentations and performance updates for internal and external stakeholders. In addition, the post holder will support training of site staff in study procedures, contribute to the development and review of standard operating procedures, maintain research databases and ensure compliance with data protection legislation, including GDPR and Caldicott principles. The role requires strong organisational skills, attention to detail and the ability to manage competing priorities across multiple concurrent studies. The post holder will work autonomously after appropriate training, while maintaining regular communication with the wider research team and leadership. Travel between UHL sites may be required in order to support research delivery across the network. Additional Information Please submit your application form without delay to avoid disappointment; we will close vacancies prior to the publishing closing date if we receive a sufficient number of completed application forms. Please check the email account (including your junk mail) that you supplied as part of your application on a regular basis following the closing date and throughout the recruitment process, as this is how we will communicate with you. UHL is an equal opportunities employer. We aim to employ a workforce that reflects the diverse communities we serve. We welcome applications from people from all backgrounds who match our job criteria. Applicants who have a disability and meet the essential criteria for the job will be interviewed if you indicate you wish to be considered under the Guaranteed Interview Scheme. If you require a reasonable adjustment at any stage of the recruitment process please make the recruitment services team aware as soon as possible. UHL is committed to helping colleagues balance the demands of both their work and personal needs through flexible working arrangements wherever reasonably practicable and subject to service needs. Disclosure and Barring Service Check Please note if you are successful in obtaining this position and the post involves regulated activity you will be required to undertake a Disclosure & Barring Service check. The Trust will pay for the check initially and the money will then be deducted from your salary over a three month period commencing on your first month's payment. The current price of a check is £38 for an enhanced and £18 for a standard check. COVID 19 Risk Assessment Due to the current Covid pandemic we have introduced a staff risk assessment into our pre-employment process. This now forms part of the mandatory pre-employment checks that will be carried out if you receive a conditional offer. The risk assessment is intended to ensure you are able to safely perform your duties in any of our work areas, and if you have been identified as being particularly vulnerable to coronavirus. Our main aim is to reduce risk and to ensure the safety of all new starters to the Trust as well as current staff, patients and visitors. If it is identified that you are within a vulnerable category, we will endeavor to make reasonable adjustments to accommodate this through discussions with both Occupational Health and your recruiting manager. Covid Vaccination Status Covid-19 vaccination remains the best way to protect yourself, family, colleagues and our patients/service users from the Covid-19 virus. We therefore continue to encourage our current and potential colleagues to get vaccinated. University Hospitals of Leicester NHS Trust holds the principles of equality, diversity and inclusion at the heart of everything it does and all that it stands for. We are committed to developing a workforce that is representative of the community we serve. We welcome applications from the diverse community of Leicester, Leicester and Rutland, to help deliver healthcare services that meets the needs of our diverse communities. At University Hospitals of Leicester NHS Trust we recognise that Artificial Intelligence (AI) tools can be used as a supportive aid during the job application process, for example to generate ideas, improve grammar, or support formatting.. We do however encourage applicants to carefully review any AI‑supported content to ensure their application genuinely and accurately reflects their own skills, experience, and motivation for the role.