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

Instructor

Michael Belotto, MPH, CCRA, CCRC

Cost

Please call for pricing and group rates 516-470-6917

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Michael Belotto, PhD, MPH, CCRA, CCRC

Director, BRANY Institute for 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’ compliance with FDA regulations and ethical guidelines. He also serves on the BRANY Institutional Review Board.

Dr. Belotto worked as a paramedic in the New York City Emergency Medical Service 9-1-1 system for 10 years, with 7 years of experience in Hospital Administration.

Dr. Belotto is a graduate of New York Medical College where he completed a Masters in Public Health with a concentration in epidemiology. He completed his doctorate in Public Health at Walden University.