Trial Management Group

CLINICAL TRIALS AND STATISTICS UNIT (ICR-CTSU)

BACKGROUND TO ICR

The Cancer Research UK funded Clinical Trials and Statistics Unit at the Institute of Cancer Research (ICR-CTSU) runs a portfolio of national and international phase III multicentre randomised controlled trials and phase II trials of targeted treatments, particularly for urological and breast cancer. The Unit is a UK Clinical Research Collaboration Registered CTU and an NCRI Cancer Clinical Trials Unit.

SUMMARY OF ROLE

We have an opportunity for a Urology trainee registrar to join the Trial Management Group (TMG) of our multicentre urological clinical trials. The trials with currently available trainee positions are: CALIBER and POUT:

http://www.icr.ac.uk/our-research/our-research-centres/clinical-trials-and-statistics-unit/clinical-trials/caliber

http://www.icr.ac.uk/our-research/our-research-centres/clinical-trials-and-statistics-unit/clinical-trials/pout

The TMG is a multidisciplinary committee responsible for overseeing the clinical, scientific and operational aspects of the trial. The TMG comprises the Chief Investigator (CI), co-investigators, key clinical and scientific collaborators, other key professionals involved in the conduct of the trial and ICR-CTSU representatives (including the trial statistical lead, the trial manager and trial statistician).

This position will provide a valuable insight into the ongoing management of multicentre clinical trials and a unique opportunity to further career development for a registrar with an interest in urological trials research.

RESPONSIBILITIES OF TMG MEMBERS

The responsibilities of a TMG member include:

oversee the on-going conduct of the trial
provide clinical or other expert guidance to ICR-CTSU and participating sites
develop strategies to optimise recruitment
input into the monitoring and classification of serious adverse events (SAEs)
input into and critically review trial reports and related documentation as required
promote the trial and maintain the profile of the trial during its follow-up phase
bring to the attention of other members of the TMG any issues considered of relevance to the on-going conduct of the trial
contribute to presentation and publication of trial outcomes.

EXPECTATIONS OF POSITION

The duration of the appointment can be flexible but a minimum commitment of 1 year is expected.

You will be required to attend 1 day in person at the London-based ICR-CTSU for a training session on the assigned clinical trial. You will be required to attend TMG meetings (which are scheduled more than 6 weeks in advance) approximately twice a year, though the option to join by telephone is available. TMG meetings last around 1.5 – 2 hours. You will be required to read and respond to email correspondence throughout the year, which may require your clinical review.

Members will be reimbursed for reasonable travel and other expenses incurred in accordance with ICR Administrative Procedures. This position offers no other financial remuneration.