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Continuing Education Program

Essentials of Initiating Clinical Research

clinical research associate & clinical research coordinator training course

This course provides a comprehensive overview of clinical development and the responsibilities of Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs). Course content focuses on key concepts and information essential to effectively function in the research arena, introducing 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. Each module is taught by a professional in the clinical research field.

Module 1: Introduction to Clinical Research, Drug, and Medical Device Development Processes

Module 2: The Clinical Research Landscape: Clinical Research Personnel, Service Providers, and the Site Selection Process  

Module 3: Human Subject Protections and Regulatory Oversight             

Module 4: Institutional Review Boards (IRB), Informed Consent, and HIPAA       

Module 5: Daily Operations: Clinical Trial Conduct, Monitoring, and Record Keeping        

Module 6: Recruitment and Retention, Drug Compliance and Accountability, and Study Close-Out Procedures  

Module 7: Safety Monitoring, Adverse Events, and Unanticipated Problems      

Module 8: Quality Assurance, Audits, and Inspections   

Module 9: Role of Data Management in Clinical Research             

Module 10: Study Budgets and Contracts: Evaluation and Negotiation   

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09/26/13 - 12/05/13
Thursdays, 6:00 - 9:00 $ 1899
(books additional)


03/08/14 - 04/5/14
Saturdays, 9:00 - 3:30 $ 1899
(books additional)


05/20/14 - 06/19/14
Tuesdays & Thursdays 6:00 - 9:00
$ 1899
(books additional)

contact hours for this course: 30.0

Essentials of Initiating Clinical Research, Health Care Statistics and Transitioning into a Career in Clinical Research may be taken together for a $100 discount!



Cancellation Policy

Requests to transfer payments to another course, and cancellations, are only accepted in writing (or by e-mail to four weeks prior to the start of the course.

Refund Policy

A refund (less $50 administrative costs) is provided only if a cancellation is requested in writing (or by e-mail to four weeks prior to the start of the course. No refunds will be made for cancellations requested after that date or for no-shows.