HHTU is a UK Clinical Research Collaboration (UKCRC) Registered Clinical Trial Unit which has the ambition to support high quality, high impact health research, leading on the design, conduct and analysis of national multi-centre research.
The post-holder will report to the HHTU Operations Manager, working with other members of the HHTU and study teams to ensure the successful management and delivery of the MABEL clinical trial. The successful candidate will join HHTU and the MABEL project at an exciting time as the project moves towards the beginning of the recruitment period.
Applicants should have previous experience as a trial coordinator/manager, high level communication skills and be computer literate. They should hold a first degree and have knowledge/experience of clinical research methodology, the research governance framework, existing UK clinical research structures, the regulatory environment and ethical systems.
Applications for secondment within the University of Hull or from Hull University Teaching Hospitals (HUTH) will be considered, but this must be discussed and agreed in principle with your line manager before an application is submitted.
Specific Duties and Responsibilities of the post
Trial Conduct and Management
Manage the efficient delivery of the MABEL trial and other HHTU studies if required, working closely with the Trial Team on day to day trial activities.
Liaise with and assist the Chief Investigator and sponsor in relation to regulatory submissions e.g Ethics/HRA, MHRA
Update study protocols and associated documentation, prepare and submit amendments to regulatory authorities as required.
To support the Trial Coordinator to conduct site set-up activities e.g SIV visits, site R&D capacity and capability confirmation, contracting, Investigator and Pharmacy Site File preparation.
Maintain the Trial Master File, including conducting version control, approval tracking, distribution and filing of documents.
Assist with central and on-site monitoring according to the agreed plan, including source data verification, data entry and quality of the entered data, adherence to study protocol, SOPs and Good Clinical Practice.
Oversee trial safety reporting processes, including AEs and SAEs, liaising with Trial Coordinator, Chief Investigator and Sponsor to ensure timely reporting within regulatory requirements.
To organise trial oversight activities e.g. trial management group, trial steering and data monitoring committees.
Liaise with the QA Manager, Trial Coordinator and Data Manager to review and resolve issues.
Communication
Assist in the preparation of study reports, protocols, publications and presentations as required.
Create study promotional and training materials including site update emails, newsletters, collaborators’ or investigator meetings and trial website.
To communicate with internal and external study personnel in a professional manner to ensure smooth running of studies.
Any other duties as allocated by the Senior Management Team.
