Trial Administrator

Oxford University Hospitals NHS Foundation Trust; Oxford; On-site; GBP 32,000 - 46,000; Full time

Job summary

Oxford University Hospitals NHS Foundation Trust is seeking a Senior Trial Administrator to provide advanced administrative oversight across a portfolio of Haematology clinical trials within the HTU. The role involves leading trial set-up activities, ensuring UK GCP compliance, managing documentation, and coordinating with consultants, research nurses, data teams and external partners.

It also includes reporting obligations and staff line management.

Qualifications

• Graduate degree in Biological Sciences or related discipline with substantial clinical research administration experience.
• Good Clinical Practice (GCP) training and evidence of further professional development.

Responsibilities

• Maintain study documentation across the trial lifecycle (amendments, annual reports, monitoring follow-up, archiving).
• Lead monthly HTU Trial Steering Committee (TSC) meetings: prepare agenda, ensure quoracy, take minutes, track actions.
• Oversee QMS processes: controlled documents, protocol amendments, training records, CAPA tracking.
• Ensure accurate data reporting and document tracking through trial databases and central trackers.
• Line manage Trial Administrator and support staff development, workload allocation and quality of administrative work.

Skills

Attention to detail

Organisational skills

Minute taking

Communication skills

Education

Graduate degree in Biological Sciences

Tools

Trial management systems

Job description

Ensure high-quality maintenance of study documentation across the trial lifecycle, including amendments, annual reports, monitoring follow-up, close-out, and archiving. Keeps an accurate database of HTU trials, timelines of trial approval by HTU TSC, time to securing slots from OUH R+D, time to first patient first visit, total recruitment, time of study closure. Support and lead a team that is administrates monthly HTU Trial Steering Committee (TSC) Meeting preparing agenda items, ensuring meetings are 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 through established systems, including trial databases and central trackers. Maintain inventories, dashboards, and oversight tools to support operational performance reporting. Handle confidential and sensitive information appropriately, adhering to information 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 set-up to close-out. This role will also oversee trial documentation, contribute to manage several studies of varying complexity across the full lifecycle, including set-up, amendment, maintenance, close-out, 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., The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.

Qualifications

• Graduate degree in Biological Sciences or a related scientific discipline, with substantial experience in clinical research administration
• Good Clinical Practice training and evidence of further relevant professional development

Desirable criteria

• Further/higher education in a relevant discipline (e.g., life sciences, health research).
• Formal training in research governance or project administration, Significant experience administering clinical trials, including set up, document management, amendments, and site file oversight
• Strong working knowledge of GCP, UK clinical research governance, ethics and regulatory processes (e.g., IRAS, MHRA notifications).
• Experience supporting or coordinating complex studies or multi centre research
• Experience working with QMS processes (e.g., SOP updates, CAPA tracking, audit preparation).
• Experience in Haematology or oncology research settings
• Experience liaising with external partners such as industry sponsors or CRO's, Excellent written and verbal communication skills, including producing high quality reports and formal correspondence.
• Strong organizational skills with ability to prioritise complex workloads and meet deadlines.
• High degree of accuracy and attention to detail across all administrative responsibilities
• Proficient IT skills in MS Office, document control tools, and trial management systems.
• Ability to work autonomously and collaboratively within multidisciplinary teams.
• Minute taking for senior level committees.
• Ability to track trial progress and produce dashboards or performance metrics. 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 of four hospitals - the John Radcliffe Hospital, Churchill Hospital and Nuffield Orthopaedic Centre in Headington and the Horton General Hospital in Banbury. Our values, standards and behaviours define the quality of clinical care we offer and the professional relationships we make with our patients, colleagues and the wider community. We call this Delivering Compassionate Excellence and its focus is on our values of compassion, respect, learning, delivery, improvement and excellence., 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. Our values, standards and behaviours define the quality of clinical care we offer and the professional relationships we make with our patients, colleagues and the wider community. We call this Delivering Compassionate Excellence, and its focus is on our values of compassion, respect, learning, delivery, improvement and excellence. These values put patients at the heart of what we do and underpin the quality healthcare we would like for ourselves or a member of our family. Watch how we set out to deliver compassionate excellence via the OUH YouTube channel. In 2023 NHS England launched its first sexual safety charter, and our Trust proudly signed it. We pledge zero tolerance for inappropriate sexual behaviour and commit to the ten core principles Oxford University Hospitals promotes a safe, respectful hiring environment. If you want to make a difference with us, come and join our team. Together, we will uphold the highest standards of care and professionalism., Sexual Safety Charter: In 2023 NHS England launched its first sexual safety charter, and our Trust proudly signed it. We pledge zero tolerance for inappropriate sexual behaviour and commit to the ten core principles Oxford University Hospitals promotes a safe, respectful hiring environment. If you want to make a difference with us, come and join our team. Together, we will uphold the highest standards of care and professionalism.