Intermediate CRA Training Seminar

This two-day seminar, worth 12 contact hours, is recommended for clinical research associates (CRAs) or others who are interested in monitoring clinical trials. It is designed for the professional who has more than a basic knowledge in the area of clinical trial management. Course topics include regulatory compliance, principles of case report form development and advanced clinical monitoring. Enrollment is limited to 55 participants.

Upcoming Dates & Locations

• San Diego, June 21-22, 2008
• Arlington, Sept. 6-7, 2008
• Houston, Oct. 18-19, 2008

Course Objectives

Upon successful completion of this course, participants will be able to:

• Discuss the development of regulatory rigor and recent changes impacting the conduct of clinical research.
• Explain the protocol development process and list the basic elements of a protocol.
• Verbalize the CRA's role in the development of case report forms.
• Develop and review consent forms to ensure regulatory compliance.
• Describe how to identify qualified investigational sites.
• Explain the budget development process and how to negotiate with clinical investigators and site management organizations.
• Identify strategies to manage site performance problems.
• Analyze means of effective communication.
• Explain the conduct of an audit.