Job summary University Hospitals of Leicester NHS Trust is seeking a motivated and organised Clinical Trials Coordinatorto 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 Main duties of the job 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. About us 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. Job description Job 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. Job description Job 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 Strong interpersonal skills. Excellent written and oral communication skills. Desirable Access to transport, as this role will require some travel. Training & Qualifications Essential Health related degree or equivalent professional qualification or experience. Desirable Attendance at leadership, development or improvement courses. GCP training. A research qualification GCP training. A research qualification Experience Essential 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 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 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 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 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 Self-motivated, with the ability to work with minimal supervision. Desirable Ability to prioritise own workload. Excellent attention to detail. Person Specification Communication and relationship skills Essential Strong interpersonal skills. Excellent written and oral communication skills. Desirable Access to transport, as this role will require some travel. Training & Qualifications Essential Health related degree or equivalent professional qualification or experience. Desirable Attendance at leadership, development or improvement courses. GCP training. A research qualification GCP training. A research qualification Experience Essential 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 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 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 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 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 Self-motivated, with the ability to work with minimal supervision. Desirable Ability to prioritise own workload. Excellent attention to detail. 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. Certificate of Sponsorship 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. 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.. 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. Certificate of Sponsorship 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. 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.. Employer details Employer name University Hospitals of Leicester NHS Trust Address Leicester Royal Infirmary Infirmary Square Leicester LE1 5WW Employer's website