Trial Coordinator

Salary: Full time starting salary is normally in the range £31,396 to £33,966 with potential progression once in post to £38,205. Grade 6  Contract Type: Fixed Term contract up to December 2026 Closes: 28th January 2024 Travel will be required for this role.  Hybrid working is possible in line with both CRCTU and University of Birmingham policies. This is an exciting opportunity to join one of the largest UK Cancer Research Collaboration (UKCRC) registered clinical trials unit in the country. The Cancer Research UK Clinical Trials Unit (CRCTU) is based in the Institute of Cancer and Genomic Sciences and specialises in running cancer clinical trials. The Unit has an extensive portfolio of phase I, II and III clinical trials in adults and children covering a wide range of cancer disease sites. The Unit also specializes in the delivery of non-cancer early phase trials including trials testing devices and biomarkers. The CRCTU receives substantial core funding from Cancer Research UK and additional funding from other charities, government and pharmaceutical companies and employs a multidisciplinary team of over 180 members of staff. The successful candidate will be responsible for the coordination of one or more clinical trials, ensuring that the trials are conducted in accordance with good clinical practice and applicable ethical, regulatory and quality standards. They will be involved in the development of trial documentation, submission of regulatory and ethical applications, the preparation and submission of pertinent reports, managing participating sites and the collaborative group, the supervision of junior staff, and preparing the data for analysis/publication. Main Duties Ensure that the trial protocol is conducted in accordance with the applicable ethical, regulatory and CRCTU quality standards and that appropriate records and audit trails are maintained. Ensure that the trial complies with current regulatory reporting requirements (e.g. of adverse events) to the relevant bodies e.g. competent authorities, ethics committees, investigators etc. Set up clinical sites, prepare ethics committee and regulatory submissions and ensure that staff at participating sites understand and are able to comply with the protocol. Monitor progress of each site and take appropriate action to ensure good recruitment, compliance with the protocol and the quality and timeliness of the data collection. Use initiative to tackle any practical difficulties reported by sites i.e. which affect recruitment, protocol or Good Clinical Practice compliance or patient safety. Conduct initiation, problem solving, monitoring, quality assurance/audit visits as required. Required Knowledge, Skills, Qualifications, Experience Higher degree in a relevant biomedical or associated subject, or graduate with strong experience in clinical research. An in depth understanding of clinical research and trial management methodology and proven ability to apply these to the development, testing and implementation of trial management procedures. Office management and clerical skills that include excellent word processing & document layout.  Experience and understanding of techniques for the management of medical research information e.g. data coding, entry validation and reporting. Ability to develop automated office procedures and to manage complex relational computer databases. Informal enquiries to Charlotte Firth c.m.firth@bham.ac.uk To download the full job description and details of this position and submit an electronic application online please click on the above ‘Apply’ button. Valuing excellence, sustaining investment We value diversity and inclusion at the University of Birmingham and welcome applications from all sections of the community and are open to discussions around all forms of flexible working