Spring, 2008 for Atlanta, GA.  Specific Date Coming Soon.

Description - This skill-based training program teaches the monitoring skills and techniques utilized by successful pharmaceutical or medical device Clinical Research Associates (CRA). The focus will be on developing a strong foundation in Good Clinical Practices and monitoring clinical quality systems and clinical data. The CRA’s roles and responsibilities are diverse and demanding; attending this course will prepare participants for the challenges ahead. This program is taught by field-experience personnel with more than 15 years of experience. 
                                                                                           
Class Agenda/Modules -                                  Instructors Make a Difference

• Good Clinical Practices
• Master Drug and Device Accountability
• Protocols and Investigator’s Brochures
• Human Subject’s Rights Protection
• Monitoring Visit Process
• CRA Macro Skill-Set
• CRA Micro Skill-Set
• Adverse Event and Effects Reporting
• Successful Regulatory and Client Audits
• Sensitivity to Scientific Misconduct and Noncompliance
  

• Sponsor Monitors
• Contract Research Organization Monitors
• Independent Consultants
• Clinical Research Managers
• Clinical Site Personnel seeking to expand their knowledge base
  

Monitoring Level - Beginner to two years of experience, preferably with a four-year medical or science degree

Class Price - $1500 (10% multiple persons  from the same organization discounts are available)