Fundamentals of Clinical Research: Modules 1-4

(One day program)

Program Description

The Fundamentals of Clinical Research training program is ideal for new Clinical Research Coordinators (CRCs), Clinical Investigators responsible for the supervision of CRCs, and other personnel who are familiar with the principles of Good Clinical Practice (GCP).  This program will provide participants with a basic overview of the role and responsibilities of a Clinical Research Coordinator (CRC).  Participants will receive a foundation of knowledge in Good Clinical Practice (GCP) and FDA regulations and requirements.

Program Objectives

  • Describe the importance of significant events in research.  
  • Explain research methods and contrast various research study designs.
  • Identify appropriate research staff and proper preparation and presentation for successful site initiation, monitoring and closeout visits.
  • Explain federal regulations, as a guide to understanding IRB decision-making processes.
  • Describe informed consent in accordance with federal regulations.
  • Learn to use appropriate source documents, record data accurately and reconcile CRFs with source documents to ensure capture of all information required by sponsors.

 

Program Schedule and Location

Time: 9:00am - 5:00pm
Place:  1981 Marcus Avenue, Suite 210, Lake Success, NY 11042
October 30, 2014 (Thursday)
 April 2015  date to be determined

Instructor

Michael Belotto, MPH, CCRA, CCRC

Cost

$1,100 per person
(10% group discount for two or more attending from the same office)
 

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Michael Belotto, MPH, CCRA, CCRC - Director, BRANY Institute of Research Education

Michael Belotto is the Director of the BRANY Institute of Research Education. He also serves as a research compliance expert responsible for auditing sites to ensure investigators and investigator staff compliance with ethical and clinical guidelines and FDA regulations. He serves on the BRANY Institutional Review Board.
Mr. Belotto was a paramedic in the New York City Emergency Medical Service for 10 years, with 7 years of experience in Hospital Administration.
Mr. Belotto is a graduate of New York Medical College where he completed a Masters in Public Health with a concentration in Epidemiology and Biostatistics.