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Clinical Trial Co-ordinator

3 months ago

Bristol, United Kingdom University Hospitals Bristol and Weston NHS Foundation Trust (UHBW) Full time

Job summary

To provide trial co-ordination / data management support for 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.

Main duties of the job

In conjunction with clinical colleagues, trial coordinate potential studies coming through the BHOC Trial Steering Group process, in addition to maintaining the existing delegated portfolio.

o Communicate with relevant support departments and gain Communicate with sponsors and Research and Development (R&D) to ensure that the appropriate Health Research Authority (HRA) packs are submitted for Set up and maintain a study site Contribute to iCT costings for commercial studies where Obtain all relevant HRA submission documents from sponsor to submit for local approval Medicines and Healthcare products Regulatory Agency (MHRA) and ethics documentation, patient information sheets, consents and any other documents required for set Obtain blood sample kits, documents and courier Compile and return requests for data regarding radiology equipment and quality Co-ordinate study initiation Ensure appropriate contracts are obtained, agreed and signed by all relevant Trust departments legal, 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 the countryside 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 patients and 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 job description document attached to this vacancy.

Person Specification

Knowledge and Experience

Essential

Previous clinical trial co-ordination related experience Previous research experience Familiarity and/or previous experience of medical terminology

Desirable

Previous NHS administration experience in oncology and/or haematology

Skills and Abilities

Essential

Good (standard) keyboard skills Ability to handle pipettes/sample handling Ability to use Microsoft office suite (Word, Excel, PowerPoint, Outlook, Access

Qualifications and Training

Essential

Good standard of general education 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