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Clinical Research Associate (48 Hours)

This Clinical Research Associate class will review informed consent, International Conference on Harmonization good clinical guidelines (ICH-GCP), and tasks involved in clinical trial monitoring and management. The course is designed for individuals interested in becoming project managers or clinical research associates (CRAs); it’s typically taken by registered nurses (RNs), nursing assistants (CNAs), licensed practical nurses (LPNs) or others seeking to move into a clinical research associate, research coordinator, or project management position. The program additionally provides exam preparation for professionals seeking to earn the CCRA® credential (Certified Clinical Research Associate) or CCRC® (Certified Clinical Research Coordinator) offered through the Association of Clinical Research Professionals. The course is taught by an MD, Ph.D. Certified Principal Investigator (CPI).

Training Includes:

  • Introduction to clinical research
  • Ethics in research principals, regulations, and ICH guidelines
  • Clinical trial documentation
  • Clinical trial site evaluation and monitoring plan
  • Monitoring planning and practice
  • Site initiation, review of trial records, and delegation of duties at the site
  • Clinical trial monitoring
  • Inventory planning and tracking
  • Audits and Source Documentation Verification (SDV)
  • CRF review, collection, and coordination of date management activities
  • Serious Adverse Event (SAE) review and regulatory compliance
  • Investigational Products (IP) management and quality control
  • Trial violations/deviations
  • Tracking of enrollments and accounting interfaces
  • Clinical trial closeout and record storage

Admission Requirements:

  • Must be 18 years of age
  • Provide proof of high school completion (high school transcripts, copy of high school diploma, or copy of the completion of GED requirements)
  • Demonstration of reading proficiency either by college transcripts, a computerized placement test, or the TABE reading test

Cost of Class:

  • Tuition/Registration $125
  • Text $80 (subject to change)

Other Fees:

  • CCRA exam fees

For more information about this class call the Yancey Learning Center at 828.682.7315.