Mid Level
Trial Coordinator (Maternity Cover)
University of Hull

Salary: £28,331 to £33,797 per annum

Closing Date: Tuesday, 11 August 2020

For more information, click here.

HHTU is a newly established trials 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, with a clear pathway to becoming a UK Clinical Research Collaboration (UKCRC) Registered Clinical Trial Unit. We are moving into the operational delivery of our initial portfolio of studies, so this is an exciting time to join the unit.

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 clinical trials across our portfolio. Applicants should have previous experience as a trial coordinator or in clinical research environment 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. 

The successful candidate will join the University of Hull during a period of expansion, with HHTU forming part of a major investment in a Health Campus and the establishment of an Institute for Clinical and Applied Health Research (ICAHR). 

Specific Duties and Responsibilities of the post

Trial Coordination

  • Ensure the smooth and efficient set up of clinical trial activities, providing support to Trial Managers.
  • To liaise with and assist the Trial Manager with regulatory submissions e.g Ethics/HRA, MHRA
  • To assist in the development of trial documents such as protocols, patient information sheets, consent forms, case report forms (paper and electronic).
  • Support site set-upg developing guidance notes and procedures for the conduct of the trial, training materials and site investigator meetings.
  • Support trial oversight activities e.g. trial management group, trial steering and data monitoring committees.
  • Assist in the development of monitoring plans in collaboration with HHTU Quality Assurance team and study Sponsor.

Study Conduct

  • Support the efficient delivery of HHTU studies, working closely with Trial Managers on the day to day trial management activities.
  • Maintain the Trial Master File for the study and its applicable documentation when required, tracking, distributing and filing documents when they are returned using HHTU electronic systems.
  • 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.
  • Monitor safety reporting on HHTU studies including AEs and SAEs, liaising with Trial Managers to ensure timely reporting within regulatory requirements.
  • Liaise with the QA Manager, Trial Manager and Data Manager to review and resolve issues.
  • Assist Trial Managers to update study protocols and associated documentation, prepare and submit amendments to regulatory authorities as required.

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.

This is a full time, temporary role required until 01/03/2021.

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