Certified Clinical Research Coordinator
Understand the concept of Clinical Research / Trials. Understand Medical Writing and Patient Safety Management. Understand Regulatory affairs and Data Management. Understanding the Drug Development Process and grasp the importance of Good Clinical Practices (GCP) & to understand the roles and responsibilities of a clinical research team.
DURATION : 3 Months
Course Outline
Module 00 : Introduction to Clinical Research
Module 01 : Basic Principles of Clinical Research
Module 02 : Clinical Trial Protocol & Amendments
Module 03 : Clinical Trial Masterfile
Module 04 : Role of a Contract Research Organization (CRO) / Site Management & Monitoring in Clinical Research
Module 05 : Ethical Guidelines for Clinical Research
Module 06 : Safety Definitions and Adverse Event reporting requirements
Module 07 : Clinical Trials Monitoring at site
Module 08 : Information Technology tools, AI in Clinical Trial Management
Module 09 : Safety and Hygiene at Clinical Trial site and workplace
Module 10 : Soft Skills & Business Writing
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