Trial Co-ordinator - Bristol, United Kingdom - University Hospitals Bristol and Weston NHS Foundation Trust

University Hospitals Bristol and Weston NHS Foundation Trust

Verified Company

Bristol, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

To provide trial co-ordination / data management support for all aspects of cancer clinical trial management within the clinical trials unit.

The trial coordinator will be an integral part of the research team.

The post holder will be expected to work closely with all members of the CTU team to provide trial management and data handling service.

The post holder will be involved in and responsible for all aspects of trial co-ordination supporting the clinical team throughout the trial process.

The work requires initiative, accuracy and attention to detail. You will be expected to represent the Trust well at all times.

All work will be carried out in accordance to the EU Directive and UK statutory instruments relating to International Conference on Harmonisation Good Clinical Practice (ICH-GCP), Research Governance and local Standard Operating Procedures and Policies.

The post holder will be based at and work from the CTU at Bristol Haematology &Oncology Centre for the majority of the time, however the post holder may also need to work elsewhere within the Trust as required.

In conjunction with clinical colleagues prepare study summaries for the BHOC monthly research forum.

Communicate with relevant support departments and gain approvals.
Communicate with sponsors and Research and Innovation (R&I) to ensure that the appropriate Health Research Authority (HRA) packs are submitted for approval.
Set up and maintain a study site file.
Calculate and negotiate costings for commercial studies.
Obtain all relevant HRA submission documents from sponsor to submit for local approval i.e. Medicines and Healthcare products Regulatory Agency (MHRA) and ethics documentation, patient information sheets, consents and any other documents required for set up.
Obtain blood sample kits, documents and courier information.
Compile and return requests for data regarding radiology equipment and quality assurance.
Coordinate study initiation meetings.
Ensure appropriate contracts are obtained, agreed and signed by all relevant Trust departments e.g. legal, R&I

For a more detailed job description and main responsibilities, please refer to the job description document attached to this vacancy.