This primary course will provide the foundational preparation needed to become a Clinical Research Associate (CRA) and/or Clinical Research Coordinator (CRC). Course content will focus on key concepts and information essential for you to effectively function in the research arena. This course can open doors to new and exciting career opportunities in clinical research. Topics include: an overview of drug development and the regulated environment; critical skills and meaningful insights in areas related to the management of pre-study activities; managing the day-to-day activities of a study; tracking the status of all study activities; scheduling study procedures and developing operational plans. In addition, you will receive information on how to get in touch with potential employers.
Course content includes:
- Introduction to Clinical Research Methods and Protocols, Drug and Medical Device Development
- Clinical Research Personnel, Service Providers, and Site Selection
- Regulatory Oversight and Human Subject Protections
- Institutional Review Boards, Informed Consent, and HIPPA
- Clinical Trial Conduct, Monitoring, and Record Keeping
- Subject Recruitment and Retention, Drug Compliance, Accountability, and Study Close-Out
- Safety Monitoring and Adverse Events
- Quality Assurance, Audits, and Inspections
- Data Management
- Contracts: Negotiation, Evaluation, and Budgets
| COURSE | DATES | TIMES | TUITION |
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NS14601 |
09/24/09 - 12/03/09 | Thursdays, 6:00 - 9:00 | $ 1799 (books additional) |
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NS14602 |
02/27/10 - 03/27/10 | Saturdays, 9:00 - 3:30 | $ 1799 (books additional) |
|
NS14603 |
05/29/10 - 06/26/10 | Saturdays, 9:00 - 3:30 | $ 1799 (books additional) |
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Essentials of Initiating Clinical Research and Health Care Statistics may be taken together for a $100 discount!