The running of a clinical trial imposes a massive administrative burden on the participating clinics, one which can often not be taken on without specialist help. The role of the trials coordinator therefore is to help with this administration and facilitate the setting up and running of trials. Coordinators carry out a variety of duties such as:
- liaising with regulatory authorities
- submission of vital documentation to appropriate bodies, such as ethics boards
- identification of patients who may be suitable for the trial
- helping with recruitment and information
- planning often complex clinic visits and arranging patient travel
- data management, helping with monitoring visits and audits.
The Coordinator is vital to the quality, safety and efficiency of a trial. The coordinator will guarantee that the research is performed within the regulatory guidelines as well as the specifications outlined in the trial protocol. They also ensure they comply with both departmental standard operating procedures (or rules) about the conduct of research and any external governance requirements.Without this role, it would be very difficult for muscle centres to take part in as many clinical trials as they are currently involved in. This is a key position which helps the muscle centres to participate in national and international clinical trials and other projects such as natural history studies. Having clinical trials coordinators at the muscle centres ensures that the families and individuals that Muscular Dystrophy UK supports have early access to trials and potential new treatments.