| Northwestern Center for Clinical Research - Pathways in Clinical Research CRA CRC Course Available, Numerous dates |
Author: Christie J. Dal Corobbo
Date: 10-04-05 15:54
The Northwestern Center for Clinical Research Pathways in Clinical Research: CRA-CRC Training Course
Description: This comprehensive course provides an overview of the clinical research process and the job responsibilities of the CRA and CRC. The course is offered in the spring and fall. The course fee includes all materials, and students completing the course with a satisfactory grade will receive 39.6 hours of CE credit.
The course consists of 12 classes, and can be taken in either 6 or 12 weeks. The course is designed to provide a thorough grounding in clinical research, new drug development, and ethical and regulatory issues, as well as guidelines on conducting and monitoring clinical research studies. Final grades and course completion are based on a midterm exam (assigned between classes 6 and 7) and final exam (assigned between classes 11 and 12) for which students must receive a passing grade of 70% or higher.
Please note that completion of this course will not provide students with certification as a CRA or 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.
Course Licensure / Additional Locations: This course was developed by Northwestern University in 2004 and is currently also offered at Boston College, Georgetown University, and Rutgers, The State University of New Jersey.
Times / Location: Classes are held at Northwestern University's Chicago Campus on Thursdays from 6:00 to 9:00 p.m., and on Saturdays from 9:00 a.m. to 4:00 p.m. Please see our online course dates for more information.
Course Dates for Fall 2005 and Spring 2006: Specific course dates can be found on our website: http://www.nccr.northwestern.edu
Thursday Class Schedule: Thursday classes are held from 6:00 to 9:00 p.m. on Northwestern University's Chicago Campus.
Class 1 Introduction to Clinical Research and the Drug Development Process
Class 2 Research Methods and Protocol Development
Class 3 Clinical Research Personnel, Service Providers, and the Site Selection Process
Class 4 Regulatory Oversight, Good Clinical Practice, and Human Subject Protections
Class 5 The Informed Consent Process, HIPAA, and the IRB
Class 6 Clinical Trial Conduct, Monitoring, Record Keeping, and Standard Operating Procedures
Class 7 Recruitment and Retention, Drug Compliance and Accountability, and Study Close Out Procedures
Class 8 Safety Monitoring and Adverse Events
Class 9 Quality Assurance, Audits, and Inspections
Class 10 Clinical Data Management
Class 11 Budget and Contract Evaluation & Negotiation
Class 12 Medical Device Trials: An Overview for CRAs and CRCs
Saturday Class Schedule: Saturday classes will be held from 9:00 a.m. to 4:00 p.m. on Northwestern University's Chicago Campus.
Class 1 Introduction to Clinical Research and the Drug Development Process
Class 2 Research Methods and Protocol Development
Class 3 Clinical Research Personnel, Service Providers, and the Site Selection Process
Class 4 Regulatory Oversight, Good Clinical Practice, and Human Subject Protections
Class 5 The Informed Consent Process, HIPAA, and the IRB
Class 6 Clinical Trial Conduct, Monitoring, Record Keeping, and Standard Operating Procedures
Class 7 Recruitment and Retention, Drug Compliance and Accountability, and Study Close Out Procedures
Class 8 Safety Monitoring and Adverse Events
Class 9 Quality Assurance, Audits, and Inspections
Class 10 Clinical Data Management
Class 11 Budget and Contract Evaluation & Negotiation
Class 12 Medical Device Trials: An Overview for CRAs and CRCs
Materials: In addition to a proprietary course manual, students will receive the following Thomson Publications textbooks: "The CRA's Guide to Monitoring Clinical Research," "The CRC's Guide to Coordinating Clinical Research," "Protecting Study Volunteers in Research," and "A Guide to Patient Recruitment and Retention." All materials are included in the price of the course.
Fees: $1750 per person. Fees may be paid via check, money order, Mastercard, or Visa. Payment must be received in full at least 5 working days prior to the first date of class in order to guarantee a spot. For those individuals whose employers are paying for the course, a letter from a manager authorizing participation and guaranteeing payment will be accepted to hold a registration.
Cancellations and Refunds: There is a $100 fee for cancellations made before the first day of class. No refunds are available after the first class.
NCCR reserves the right to cancel any course with insufficient enrollment 10 days prior to the class date. In such cases, all fees are refunded.
CE Credit: This course is approved for 39.6 contact hours by the Illinois Nurses Association, an accredited approver by the American Nurses Credentialing Center's Commission on Accreditation.
Registration: To register, download the registration form from our course web page: http://www.nccr.northwestern.edu/education_CRACRC.htm
or call our Office of Education and Training at 312-503-7952. Feel free to call us or email us at nccr@northwestern.edu if you have any questions!
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Author |
Date |
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Northwestern Center for Clinical Research - Pathways in Clinical Research CRA CRC Course Available, Numerous dates new |
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Christie J. Dal Corobbo |
10-04-05 15:54 |
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