Senior Trial Coordinator

1 week ago

Birmingham, Birmingham, United Kingdom University of Birmingham Full time

Position Details
Institute of Cancer and Genomic Sciences, Cancer Research UK Clinical Trials Unit (CRCTU)

Location:
University of Birmingham, Edgbaston, Birmingham UK

Full time starting salary is normally in the range £34,980 to £44,263 with potential progression once in post to £46,974

Grade: 7

Full Time, Fixed Term contract up to June 2025

Closing date: 28th May 2024

Hybrid working is possible in line with both CRCTU and University of Birmingham policies

Background


This is an exciting opportunity to join one of the largest UK Clinical Research Collaboration (UKCRC) registered clinical trials units in the country.

The Cancer Research UK Clinical Trials Unit (CRCTU) is based in the Institute of Cancer & Genomic Sciences, University of Birmingham and specialises in running cancer clinical trials.

The Unit has an extensive portfolio of phase I, II and III clinical trials in adults and children covering a wide range of disease sites.

The Unit employs a multidisciplinary team of over 180 staff including statisticians, systematic reviewers, trial management staff, research nurses, monitors, programmers, administrators and IT staff.

The CRCTU receives substantial core funding from Cancer Research UK and additional funding from other charities, government and pharmaceutical companies.


Role Summary
This is a very varied and demanding post with considerable responsibility.

Senior Trial Coordinators are responsible for managing a portfolio of trials and the staff working on those projects in addition to actively coordinating trials.

They are expected to contribute to the design, conduct, analysis, publication and presentation of clinical trials research. They must be able to use their own initiative, be an effective leader, team player and excellent communicator.

They will usually take on a role which carries a national profile, and as such they play a pivotal role in promoting the research activity of the CRCTU and developing its external collaborative network and establishing funding contacts.


Main Duties

  • Keep up to date with current research literature and developments in the disease site speciality and Trial Management profession. Maintain relevant bibliographies by regular literature searches and critical review. Bring ideas for innovative trials to the attention of the team's Clinical Lead. Write literature reviews, develop and publish innovative approaches to improving trial methodology.
  • Prepare appropriate interim publications (e.g. meeting abstracts) to maintain the research profile of the trial, and play a pivotal role in the preparation and timely completion of final research publications.
  • Keep up to date with changes in trial methodology, regulatory issues and new legislation. Help develop strategies for their implementation at team level and also national level if appropriate to the trial. Help ensure that new skills, knowledge and best practice are disseminated internally and externally to study sites if appropriate. This will involve contributing to the quality assurance programme (i.e. by writing / approving / implementing Trials Unit Standard Operating Procedures).
  • Personally manage selected trials taking a lead in preparing and organising meetings, reports and other activities of high importance, complexity and sensitivity that require specialist knowledge or expertise. This will generally include settingup new trials, negotiation with key external bodies, overseeing the settingup and monitoring of clinical sites and ensuring trials are run in accordance with current legislation.
  • Take primary responsibility for ensuring that trial research data is complete and accurate. Work closely with members of the statistical team to validate the data set.
  • Responsible for management of junior staff with respect to daytoday supervision, motivation and support of the staff (including work allocation, cover rotas, problem solving, staff development and monitoring performance). Advise and assist in the appointment and training of the junior trial management staff. Mentor, coach, and guide other members of the team as necessary.
  • Obtain appropriate regulatory and ethical approval for individual clinical trials. Ensure Standard Operating Procedures for safe conduct of trial are followed (e.g. reporting of adverse events to regulatory authorities and Data Monitoring Committee).
  • Prepare trial progress reports as required by the regulatory authorities, ethics committees, trial Steering and Data Monitoring Committees, funding bodies and external collaborators
  • Provide first point of contact for daytoday queries from study sites regarding compliance with the team's portfolio of research protocols and provide cover for other Trial Coordinators.
  • Promotion of the team's portfolio by the preparation of newsletters, posters and by presenting at local, national and occasionally international scientific meetings.
  • Be able to use own initiative to solve research and st

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