Indian Rocks Beach, FL 33785
(727) 642-0182
(813) 774-8657
(727) 593-3595 FAX
"Helping People Learn Compliance and Science" SM
The Clinical Research Coordinator:
Necessary Knowledge and Skills
ABOUT THE COURSE
“The Clinical Research Coordinator: Necessary Knowledge And Skills” is a one five-day course designed to transition registered nurses from the hospital work environment into the world of contract clinical research in the pharmaceutical and medical device industries. The course materials are developed from the current Good Clinical Practices (CGCPs) regulations and the personal experience of the instructors in the pharmaceutical and medical device industries.WHO SHOULD ATTEND
Registered nurses from the hospital work environments who are making the transition into the world of contract clinical research in the pharmaceutical and medical device industries. Also, personnel who are currently in the contract research industry who are in need of a review of CGCP regulations and current industry standards will also benefit from this course.COURSE OUTLINE
1. History of FDA, CGCPs and Vocabulary Review
2. The Drug Development Process: Pre-Clinical to Post Approval
3. Clinical Research Team Organizational Structure, Roles and Responsibilities
4. Sponsor Pre-Study or Site Qualification Visit
5. Sponsor Site Initiation or Investigator Meeting
6. Institutional Review Board (IRB) Submission and Approval
7. Subject Recruitment and Advertising
8. Subject Pre-Screening and Screening
9. The Informed Consent Process
10. Protocol Compliance
11. Study Manager Documentation Skills
12. Clinical Skills Review
13. Investigational Product Management
14. Adverse Event Reporting
15. Regulatory Management
16. The Close Out Visit
17. Sponsor Audits and FDA Inspections
18. Some Practical Skills
19. Review
ADMINISTRATION
The course is five days in length. Cost is $2500 per person. Payment can be made by personal check, company check, purchase order, or by MasterCard, Visa, or American Express. Registration can be made on-line or via telephone.
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