Study Coordinator Training
Study coordinators perform essential activities towards the successful execution of clinical research. Study coordinators are tasked with an expanding set of responsibilities including patient safety and recordkeeping, federal regulations compliance, IRB compliance, interacting with Sponsors and Clinical Research Organizations and dealing with budget and contract negotiation.
Clinical Trials are increasingly complex. A recent report from the Tufts Center for the Study of Drug Development found the typical clinical trial requires about 170 procedures and has 13 endpoints. Additionally, the average study today has over 50 inclusion/exclusion criteria, over 180 pages of case report forms and 11 patient visits over 175 days. This has increased from the period 2000-2003 when there was an average of 105.9 procedures per protocol, 31 inclusion/exclusion criteria and an average of 55 pages of case report forms.1 Study coordinators are faced with mounting responsibilities while confronting increasing trial complexity.
It is critical for the protection of subjects and success of the trial that Study Coordinators are adequately trained to perform all of their delegated duties, and understand all of their responsibilities.
The Study Coordinator Development Program is designed to facilitate the education process. It’s comprised of a basic set of training modules and specific modules given coordinator’s responsibilities. Study Coordinators at KUMC must complete all basic required modules. Additional ongoing training is based on credentials, past experience, education and your position at KUMC.
Access training: ANGEL
1 – Baumann, Jeannie. “Extra Clinical Trial Procedures Cost Up to $5 Billion a Year, Study Finds.” Bloomberg BNA: Medical Research Law and Policy Report (July 18, 2012)