Trial Administrator

Ensure high-quality maintenance of study documentation across the triallifecycle, including amendments, annual reports, monitoring follow-up,close-out, and archiving.Keeps an accurate database of HTU trials, timelines of trial approval byHTU TSC, time to securing slots from OUH R+D, time to first patient firstvisit, total recruitment, time of study closure.Support and lead a team that is administrates monthly HTU Trial SteeringCommittee (TSC) Meeting preparing agenda items, ensuring meetingsare quorate, taking minutes, ensuring actions are completed.Support oversight and continued improvement of QMS processes,including controlled documents, protocol, amendments, training records,and CAPA tracking.Ensure accurate data reporting, and document tracking throughestablished systems, including trial databases and central trackers.Maintain inventories, dashboards, and oversight tools to supportoperational performance reporting.Handle confidential and sensitive information appropriately, adhering toinformation governance standards, The Senior Trial Administrator will provide advanced administrative oversight and coordination across a portfolio of Haematology clinical trials within the Haematology Trials Unit (HTU). Building on the Band 5 Trial Administrator role, the Senior Trial Administrator will lead set up related activities of Haematology Clinical Trials, ensuring compliance with UK GCP, regulatory requirements, OUH policies, and sponsor expectations. The post holder will act as a senior point of contact for consultants, research nurses, data teams, and external partners, supporting the efficient management of trials from setup to closeout. This role will also oversee trial documentation, contribute to manage several studies of varying complexity across the full lifecycle, including setup, amendment, maintenance, closeout, and support reporting obligations to sponsors, and regulatory bodies. In addition, the Senior Trial Administrator will line manage Trial Administrator, contributing to staff development, allocating workloads, ensuring quality of administrative work, and supporting continuous improvement.,

• oSignificant experience administering clinical trials, including set up, document management, amendments, and site file oversight
• oStrong working knowledge of GCP, UK clinical research governance, ethics and regulatory processes (e.g., IRAS, MHRA notifications).
• oExperience supporting or coordinating complex studies or multi centre research
• oExperience working with QMS processes (e.g., SOP updates, CAPA tracking, audit preparation).
Desirable
• oExperience in Haematology or oncology research settings
• oExperience liaising with external partners such as industry sponsors or CRO's
  
  oGraduate degree in Biological Sciences or a related scientific discipline, with substantial experience in clinical research administration
• oGood Clinical Practice training and evidence of further relevant professional development, oFurther/higher education in a relevant discipline (e.g., life sciences, health research).
• oFormal training in research governance or project administration, oExcellent written and verbal communication skills, including producing high quality reports and formal correspondence.
• oStrong organizational skills with ability to prioritise complex workloads and meet deadlines.
• oHigh degree of accuracy and attention to detail across all administrative responsibilities
• oProficient IT skills in MS Office, document control tools, and trial management systems.
• oAbility to work autonomously and collaboratively within multidisciplinary teams.
  
  Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts in the country. It provides a wide range of general and specialist clinical services and is a base for medical education, training and research. The Trust comprises four hospitals - the John Radcliffe Hospital, Churchill Hospital and Nuffield Orthopaedic Centre in Headington and the Horton General Hospital in Banbury.
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