About this role
Job summary
The role involves providing comprehensive trial coordination and data management support for cancer clinical trials within the Clinical Trials Unit (CTU). This support may span various tumour sites and include radiotherapy trials.
As an integral member of the CTU research team, the trial coordinator will collaborate closely with all stakeholders. The post holder will be responsible for all aspects of trial coordination, supporting the clinical team throughout the trial process.
This position demands initiative, precision, and meticulous attention to detail. The successful candidate will be expected to represent the Trust with professionalism at all times. All work will be conducted in accordance with the EU Directive and UK statutory instruments related to International Conference on Harmonisation Good Clinical Practice (ICH-GCP), Research Governance, and local Standard Operating Procedures and Policies. The post holder will primarily be based at the CTU at Bristol Haematology & Oncology Centre but may also be required to work at other locations within the Trust as needed.
Main duties of the job
In collaboration with clinical colleagues, coordinate potential studies progressing through the BHOC Trial Steering Group process, while also managing the existing delegated portfolio.
Liaise with relevant support departments to secure necessary approvals. Communicate with sponsors and the Research and Development (R&D) team to ensure the submission of appropriate Health Research Authority (HRA) packs for approval. Establish and maintain a comprehensive study site file. Contribute to iCT costings for commercial studies, where applicable. Obtain all necessary HRA submission documents from sponsors for local approval, including Medicines and Healthcare products Regulatory Agency (MHRA) and ethics documentation, patient information sheets, consent forms, and any other required setup documents. Procure blood sample kits, documentation, and courier information. Compile and submit data requests regarding radiology equipment and quality assurance. Coordinate study initiation meetings. Ensure that all relevant contracts are obtained, agreed upon, and signed by the appropriate Trust departments, such as legal and R&D.
About us
University Hospitals Bristol and Weston NHS Foundation Trust (UHBW) is one of the largest acute Trusts in the country, bringing together a combined workforce of over 13,000 staff and over 100 different clinical services across 10 different sites, serving a core population of more than 500,000 people across South West England.UHBW has been rated by the CQC as 'Good' overall and our staff are proud to deliver excellent care to the people of Bristol, Weston and beyond. As a forward thinking multi-award winning Trust and a digital exemplar committed to improving patient care, our world-leading research and innovations are having a positive local and global impact. Our hospitals are spread across Bristol and Weston, join us and you can enjoy the very best of both worlds; city living within a stone's throw of thecountryside or beside the seaside, both with easy access to all that the South West has to offer. UHBW is committed to safeguarding and promoting the welfare of children, young people and vulnerable adults. As an equal opportunities employer actively working towards a diverse workforce we aim to recruit and retain a workforce which represents the rich diversity of the local population at all levels and are committed to designing our services around the needs of individual patientsand those around them. Anonymous information will be used from your application in order to ensure we're meeting our pledge.
Job description Job responsibilities
For a more detailed job description and main responsibilities, please refer to the Band 4 and Band 5 job descriptions as attached.
Person Specification
Knowledge and Experience Essential
Previous clinical trial co-ordination related exposure Familiarity and/or previous experience of medical terminology
Desirable
Previous NHS administration experience in oncology and/or haematology Previous research experience
Skills and Abilities Essential
Good (standard) keyboard skills Ability to use Microsoft office suite (Word, Excel, PowerPoint, Outlook, Access, SharePoint)
Desirable
Ability to handle pipettes/sample handling
Qualifications and Training Essential
Good standard of general education e.g. Maths and English Degree or similar health related qualification or equivalent range of experience within the role
Desirable
Current GCP certificate
Aptitudes Essential
Ability to work calmly and effectively under pressure Ability to communicate effectively and deal tactfully with people Excellent organisational skills Use initiative and be innovative within the scope of the role To be able to prioritise workload Excellent accuracy and attention to detail Ability to work within a team
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.
Employer details Employer name Bristol NHS Foundation Trust
Address Bristol Haematology and Oncology Centre
Horfield Road
Bristol
BS2 8ED
United Kingdom
Employer's website https://www.uhbw.nhs.uk/ (Opens in a new tab)