About this role
Job summary
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
This is not an exhaustive description of the role; please refer to the full job description for complete details.
PLEASE NOTE
" APPLICANTS WHO HAVE PREVIOUSLY APPLIED FOR THIS POSITION ARE ENCOURAGED NOT TO APPLY"
Main duties of the job
This is not an exhaustive description of the role; please refer to the full job description for complete details.
About us
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 2023NHS 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.
Job description Job responsibilities
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.
Person Specification
Qualifications Essential
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
Desirable
oFurther/higher education in a relevant discipline (e.g., life sciences, health research). oFormal training in research governance or project administration
Knowledge and Experience Essential
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
Skills and Abilities Essential
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.
Desirable
oMinute taking for senior level committees. oAbility to track trial progress and produce dashboards or performance metrics.
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 UK Visas and Immigration website (Opens in a new tab).
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. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Employer details Employer name Oxford University Hospitals NHS Foundation Trust
Address Churchill Hospital
Old Road , Headington,
Oxford
OX3 7LE
United Kingdom
Employer's website https://www.ouh.nhs.uk/ (Opens in a new tab)