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. Person specification Communication and relationship skills Essential criteria Strong interpersonal skills. Excellent written and oral communication skills. Desirable criteria Access to transport, as this role will require some travel. Training & Qualifications Essential criteria Health related degree or equivalent professional qualification or experience. Desirable criteria Attendance at leadership, development or improvement courses. GCP training. A research qualification GCP training. A research qualification Experience Essential criteria Previous experience in research/hospital/NHS/healthcare setting Knowledge and experience of maintaining complex relationships Basic understanding of the NHS Basic understanding of clinical trials Desirable criteria Previous experience within surgical research and or research methods Experience of project management with minimal supervision Working on Industry Sponsored clinical trials Experience of setting-up a clinical trial Analytical and Judgement skills Essential criteria Evidence of continuous personal and professional development Excellent communication (verbal and written) and interpersonal skills to communicate with all levels of staff and patients and carers face to face, on the telephone or in writing Skills Essential criteria Knowledge of clinical and research terminology. Up to date computer/keyboard skills and working knowledge of computer-based packages e.g. Word and Excel The ability to access, input and retrieve electronic patient information Ability to work across boundaries, integrating with multidisciplinary staff in relation to research trials Desirable criteria Excellent computer skills Evidence of previous patient/client and MDT contact within work environment. Inputting/extracting information into databases. Ethical and R&D approval process Principles of trial methodology Preparation of presentations Software packages Writing scientific papers REDCap or other data collection platforms ICH-GCP training Planning and organisation skills Essential criteria Self-motivated, with the ability to work with minimal supervision. Desirable criteria Ability to prioritise own workload. Excellent attention to detail. 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. Employer certification / accreditation badges