Author: Karen E. Woodin, Ph.D

The CRC’s Guide to Coordinating Clinical Research was designed as a training resource for investigative site staff. It explains in detail the research process from the site and Clinical Research Coordinator (CRC) perspective. The learning objectives for this activity are: identify the regulations governing clinical research; organize a clinical practice to manage clinical trials successfully to their completion; describe the drug development process and determine the role of the CRC at a clinical study site by describing the general responsibilities associated with that role.

• CRC responsibilities, problems and opportunities
• Regulations and good clinical practices (GCPs)
• Writing and implementing standard operating procedures (SOPs)
• Preparing for a study, including case report forms (CRFs), site evaluations, investigator meetings, monitoring visits and more
• Adverse events and safety monitoring
• Sample forms, logs and checklists