Clinical Research Associate

Program Description
A Clinical Research Assoicate (CRA), also known as a monitor, plays a fundamental role in ensuring the success of a project, as he/she is typically the first to identify data discrepancies and regulatory issues at a clinical trial site. CRAs assess the quality and the integrity of the data being produced at a clinical trial site that may be used to file a New Drug Application (NDA) and gain marketing approval; they ensure that the safety of a study participant is not jeopardized; they assess a site’s compliance with the clinical trial protocol and the Code of Federal Regulations (CFR); they may evaluate clinical facilities, assessing their ability to conduct a clinical trial; they address study-related questions with site staff; they write reports documenting the conduct of clinical trials at a clinical facility; they review regulatory documents; they assist project managers and other clinical team members with project oversight and management; and they may serve as mentors for junior CRAs. This array of responsibility demands that the CRA not only have a thorough understanding of the clinical trial protocol and the disease being studied, but that the CRA also has a clear understanding of the federal regulations and regulatory demands associated with conducting clinical trials, has the ability to manage people, has problem solving skills, and has the ability to write effectively and communicate clearly.

This certificate program will be 7 Saturday sessions beginning September 19, 2009 and ending October 31, 2009 and will address the following topics:

• An Introduction to Clinical Research
• The US Food and Drug Administration and Clinical Research
• Good Clinical Practice (GCP) and the International Conference of Harmonization (ICH)
• The clinical research trial – start up
• Selecting investigational sites
• Collection and review of critical regulatory documents
• Initiating investigational sites
• Monitoring investigational sites
• Safety surveillance
• Closing investigational sites
• Submitting the New Drug Application (NDA)
• Globalization of Clinical Trials
• Career paths for the CRA