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. This course opens 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.

Course content includes:

• Introduction to Clinical Research, Drug and Medical Device Development Process
  
  
• The Clinical Research Landscape: Clinical Research Personnel, Service Providers and the Site Selection Process.
  
  
• Human Subject Protections and Regulatory Oversight
  
  
• Institutional Review Boards (IRB), Informed Consent and HIPAA
  
  
• Daily Operations: Clinical Trial Conduct, Monitoring and Record Keeping
  
  
• Recruitment and Retention, Drug Compliance and Accountability and Study Close-Out Procedures
  
  
• Safety Monitoring, Adverse Events and Unanticipated Problems
  
  
• Quality Assurance, Audits and Inspections
  
  
• Role of Data Management in Clinical Research
  
  
• Study Budgets and Contracts: Evaluation & Negotiation
  Essentials of Initiating Clinical Research
  
  

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

REGISTRATION

• Register online and pay with credit card
• Register online for both Essentials of Initiating Clinical Research and Health Care Statistics for a $100 discount!
• Download our registration form and pay by check

Cancellation Policy

Requests to transfer payments to another course, and cancellations, are only accepted in writing (or by e-mail to sonce@bc.edu) 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 sonce@bc.edu) four weeks prior to the start of the course. No refunds will be made for cancellations requested after that date or for no-shows.