Clinical Research Associates are responsible for conducting studies to examine the safety and efficacy of new drugs in human patients. These studies are known as clinical trials. Clinical Research Associates follow GCPs (Good Clinical Practices) and ICH (Registration of Pharmaceuticals for Human Use) practices and help coordinate data management efforts.
Other names for this position are Clinical Operations Associate or Clinical Research Monitor.
Clinical Research Associate’s provide administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs (Clinical Research Organizations).
This job involves monitoring study sites, performing routine data collection from patients, verifying data sources, and reviewing regulatory documents/files to ensure that documents are in compliance with protocols, regulatory requirements, SOPs (standard operating procedures), and are aligned with the Monitoring Plan. Some clinical research associates assist in reviewing study protocols, informed consent forms, and case report forms. They may also participate in developing monitoring plans, abstracts, presentations, manuscripts and clinical study reports under supervision.