UH
University Hospitals Bristol and Weston NHS Foundation Trust
Clinical Trial Co-ordinator
Description
Role Overview
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.
Responsibilities
- Collaborate closely with all stakeholders as an integral member of the CTU research team.
- Responsible for all aspects of trial coordination, supporting the clinical team throughout the trial process.
- Demonstrate initiative, precision, and meticulous attention to detail.
- Represent the Trust with professionalism at all times.
Compliance
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.
Location
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.
Key Duties
- In collaboration with clinical colleagues, coordinate potential studies progressing through the BHOC Trial Steering Group process while 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 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) documentation, ethics documentation, patient information sheets, consent forms, etc.
- Procure blood sample kits, documentation, and courier information.
- Compile and submit data requests regarding radiology equipment quality assurance.
- Coordinate study initiation meetings.
- Ensure that all relevant contracts are obtained, agreed upon, signed by appropriate Trust departments such as legal and R&D.
About University Hospitals Bristol & Weston NHS Foundation Trust (UHBW)
University Hospitals Bristol & Weston NHS Foundation Trust is one of the largest acute Trusts in England with a combined workforce of over 13,000 staff across 10 different sites serving more than 500,000 people across South West England. UHBW has been rated โGoodโ overall by CQC; our staff are proud to deliver excellent care locally while being committed to improving patient care through world-leading research innovations impacting both locally and globally.
Work Environment
Our hospitals are located across Bristol and Weston offering city living close to countryside or seaside attractions along with easy access to everything South West England has available.
Commitment
UHBW is dedicated to safeguarding childrenโs welfare along with promoting equal opportunities aiming towards a diverse workforce representing local population diversity at every level while designing services around individual patients' needs.
Contact Information
For further details or informal visits contact:
Name: Matt Baxter
Job title: CTU Performance & Operations Manager
Email address: [email protected]
Telephone number: 0117 342 6735
or
Name: Anja Schmidtmann
Job title: Senior Trial Coordinator
Email address: [email protected]
Telephone number: 0117 342 6743