Senior Trial Coordinators (STC) oversee a portfolio of clinical trials that are managed on a day to day basis by trial coordinators and data managers. They are primarily responsible for preparing grant applications for funding, ensuring compliance of the trials with the protocol, SOPs and legislation, overseeing the progress of projects and offering advice to staff on amendments/reporting medical events etc. It is a varied role with any two days rarely being the same. An STC will typically oversee several open and closed trials as well as coordinating a small number of funding applications.

Trial Coordinators (TC) are responsible for one or more clinical trials at all stages of the trial lifecycle. This includes developing documents for regulatory and/or ethical submission, setting up participating sites, monitoring the ongoing progress of studies, preparing trial reports and assisting with the end of trial publication and closure. It is an incredibly varied role which can be challenging when juggling the demands of several projects but it is exceedingly rewarding.

Data Managers' (DM) main purpose within the unit is to ensure the accuracy and completeness of data collection, and adherence to trial protocols. Much of their time is spent transferring data from case report forms to trial databases. They also have a vital role in supporting trial teams in administrative tasks and are a key point of contact for hospitals participating in our trials.

Trials Assistants (TA) facilitate the delivery of clinical trials by providing support for the team. They provide administrative assistance (including filing, tracking incoming forms, data entry and arranging meetings) and often act as the first point of call for general site queries.

Database Developers (DD) are responsible for the development of trial databases and other standardised database management tools. They work with trial teams to ensure consistency of trial data throughout the unit, advising on development of case report forms and study database specifications. They provide reports for patient safety monitoring and for tracking of site performance during a trial, as well as ad hoc reports of trial data.

With around 100 employees the CTC requires a dedicated administration team to provide support and manage the day-to-day running of the centre. The finance team oversee the financial running of the centre and the trials themselves from the initial bid process onwards.

Trials can only be run within the legislative frameworks that govern clinical trials, data protection, sample collection etc. The requirements are incorporated into trial protocols and documents, in terms of conducting the trial and reporting any side-effects that arise from the use of a particular treatment. At the CTC regulatory and pharmacovigilance teams ensure the regulations are incorporated into the CTC’s procedures and templates, and oversee compliance with them. The teams manage the CTC’s quality system, which includes regular internal audits to ensure GCP and GxP requirements are achieved.

Trial monitoring is essential to the proper execution of a trial, the accuracy of the data being captured and the welfare of the patients taking part. The type of monitoring activities undertaken will depend on the nature of risks identified with a trial. Monitoring activities include remote review of paperwork and data, and regular or ‘triggered’ on-site monitoring visits. On-site monitoring visits will be undertaken by a trial monitor, by the trial coordinator or a combination of both. Our trial monitors and trial coordinators work closely with site staff during on-site visits to assess protocol and GCP compliance, and to help ensure patient safety and the collection of good quality data.

Our team of statisticians are involved from the very start of a trial's development. They collaborate with other members of the Trial Management Group to ensure the trial is well designed, and provide interim and final analyses for review and publication.

Trials involve large amounts of data and reliable IT systems are absolutely essential. The core infrastructure is managed locally within the unit along with the data systems used to record, store and process trial data. The IT team includes hardware, software and systems specialists to install, manage, maintain and develop the many systems that lie at the heart of the unit's work.