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.