As a Clinical Research Associate (CRA) working within a Sponsor or CRO company, your role is defined by Good Clinical Practice under ICH/GCP. You perform a variety of clinical operations and monitoring activities including study planning, development, study conduct, closeout and post-study. Traditionally, CRAs visit and work with the investigative site staff to ensure proper study conduct, compliance with the clinical trial protocol, adherence to SOPs and ICH/GCP, and the timely generation and collection of quality data. The protection of research subjects and the validity of the data during the course of the clinical trial are central to your role as a CRA.
Your responsibilities include the recruitment of potential Principal Investigators, clinical trials management of site performance and patient recruitment along will being the main line of communication with the investigative site and the Sponsor or CRO company. In this New CRA category, you should have at least one year of actual monitoring experience.