 | |  | This course is designed to provide: An overview of the clinical research process, an introduction to roles of key personnel involved in clinical research, and an in-depth review of job responsibilities of a clinical research coordinator and best practices for success in this position. Topics include: Informed Consent, Clinical Trial Initiation and Budget Negotiation, FDA Forms and Procedures, Regulatory Documents and Binder Maintenance, Source Documents, Study Initiation and Close-Out Visits, Subject Recruitment, Compliance and Retention, Drug Compliance, Storage, and Documentation, IRBs, IRB Submissions, and HIPAA, Adverse Events and Safety Monitoring, Quality Assurance Audits and Monitor Visits, and Preparing for FDA Audits Class times and dates are listed below. Each session is approximately 2 hours in length with a 15 minute break in each session. 2008 Online CRC Basic Training Schedule | Months | Dates | Times | April, Wednesdays | 4/2, 4/9, 4/16, 4/23 | 2:00 PM - 4:30 PM (CST) | May, Thursdays | 5/1, 5/8, 5/15, 5/22 | 10:00 AM - 12:30 PM (CST) | June, Wednesdays | 6/4, 6/11, 6/18, 6/25 | 2:00 PM - 4:30 PM (CST) | July, Wednesdays | 7/9, 7/16, 7/23, 7/30 | 2:00 PM - 4:30 PM (CST) | August, Thursdays | 8/14, 8/21, 8/28, 9/4 | 10:00 AM - 12:30 PM (CST) |
Please note that completion of this course will not provide students with certification as a CRC. One to two years of full-time work experience in the field are required before an individual is eligible to sit for the CRA or CRC certification exams. Cancellations are not permitted for this program. You may be eligible to reschedule the class if necessary. Please contact nucats-ed@northwestern.edu with questions regarding rescheduling. If you have any questions, or if you would like more information, please contact us at nucats-ed@northwestern.edu or call our Office of Education and Training at 312-503-7952.
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