The basic module is designed to provide students Clinical Research Associates monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Reviews regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start up process including; reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. Would participate in clinical training programs and maintain awareness of developments in the field of clinical research.

The intermediate module focuses on practical training for excellent administrative, interpersonal, organizational and time management skills. Stress training for working in a high volume environment handling multiple tasks.

The advanced module provides an opportunity to engage in independent clinical research projects. The focus is on drug delivery, dosage form design, process development and scale-up technology.

Students who are at the final stages of their program and have excelled in all aspects of their training may apply their expertise for an internship. These opportunities allow selected students to gain additional experience through working with staff and faculty to Assisting to the seniors for regulatory submissions including IND and NDA projects. Selection management of CROs, instructing, training, and overseeing site personnel, field monitors and CRO personnel.