'Clinical Research Associate Program'
A complete Clinical Research Associate/Monitor Training Program consisting of Twenty (20) individual training modules of a minimum of 40 hours of total training covering:
Introduction to Clinical Research Monitoring
Conducting a Clinical Investigator Qualification Visit
Good Clinical Practices
21 CFR (Code of Federal Regulations) Requirements
Master Drug and Device Accountability
Protocols and Investigator’s Brochure
Human Subject’s Rights, Safety, and Welfare 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
Essential Regulatory Documents
You will complete one training module at a time in a recommended order, receiving a Norton Training Institute training certificate for each module as well as the overall program. Take as much reasonable time (usually about 30 days) you need to complete each module, and you will automatically be enrolled in the next module upon completing the current module. Some students complete the entire CRA Program in a month, while others will take an entire year. In any case, the Program is self-paced to meet your schedule.
Course Modules include:
1. Introduction to Clinical Research Monitoring
2. Legal Training for Determining Qualifications of Clinical Investigators
3. Conducting a Clinical Investigator Qualification Visit
4. Essential Regulatory Documents
5. Clinical Operations Introduction to Standard Operating Procedures
6. Clinical Operations GCP and ICH Training Series - 11 Individual Modules
....a. Advertising for Study Subject Recruitment
....b. Clinical Research Personnel C.V.’s & Licenses
....c. Completing and Maintaining Case Report Forms
....d. Completion of Form FDA 1572
....e. Confidentiality of Clinical Trial Information
....f. Corrective and Preventative Actions Procedures
....g. Documenting Delegation of Authority
....h. Interim Monitoring Visits
....i. Monitoring Close-Out Visits
....j. On Call or Off Hours Procedures
....k. Study Team Training
7. Norton Method: Auditing Skills for Monitors
8. Reporting of Pre-Market Adverse Events
9. Noncompliance Causalities and Securing Compliance at the Clinical Investigator
10. Sensitivity to Clinical Research Fraud and Misconduct
Formal Continuing Education Units (CEUs) and a 'Non-Credit Program Certificate' issued by the University of South Carolina are available as well for an additional $100 fee. Contact The Norton Training Institute to sign up for this option at 803-233-4809 or 866-552-8832.
As with all of our training, these modules are skill and regulation-focused, and prepared by a former FDA Investigator, Sponsor Monitor and current Industry Auditor, Consultant and Instructor that retains a PhD. Learn how to build Compliance into Research through a Systematic Approach to Monitoring, and not a Lagging Data-Only Focus.
You receive audio, visual and hands-on training content in each module with our Instructor-Narrated Graphical Text, Digital Library, Instructor Chat, Frequently Asked Questions, Glossary, Quizes and Training Certificate. We are with you throughout the training program, monitoring your progress, answering your questions, addressing your unique needs, answering email and your phone calls.
Upon completion of the entire Program, call on us for assistance with your CV/Resume preparation, job placement, career advancement and general career advice.
To date, 150 students have completed the CRA Program since 2008.
We recommend that anyone taking this Program have a degree and/or experience in the Medical or Science Fields, such as a Nurse, Scientist, Medical Technologist or Biologist, or direct experience in Clinical Research such as Research Coordinator, Project Manager, or Investigator. Without this education and/or experience you may struggle with some of the terms utilized in the training content and case studies in particular, which can be compensated for by thoroughly reviewing the on-line Glossary found in this Program first.
Once you enroll in this Program, please go to Module NT20 first to see the order in which the Modules should be taken.
Twenty Training Modules totaling approximately 40 hours for New or Experienced Monitors
$800.00
Pay as You Go Program Available for an additional $25 fee.
Please call to arrange at 803-233-4809 or 866-552-8832.
BE SURE TO ENTER PROMOTIONAL CODE CRA3 WHEN YOU SIGN UP FOR THIS COURSE.
