Coming Soon

Certified Clinical Research Associate

This is the first step to understanding the various facets of the clinical research industry. 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. Reporting audit queries by citing evidence of work. This will establish your role as a clinical research associate in the Industry. You will understand the different regulatory bodies and their common and uncommon ethical practices.

DURATION : 4 Months

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Course Outline

Module 00 : Life Sciences Industry & Regulations for Clinical Research
Module 01 : Introduction to Clinical Research
Module 02 : Basic Principles of Clinical Pharmacology and Drug Action
Module 03 : Clinical Trial Protocol & Amendments
Module 04 : Informed Consent (ICD)
Module 05 : Clinical Trial Masterfile
Module 06 : Role of a Contract Research Organization (CRO) / Site Management & Monitoring in Clinical Research
Module 07 : Ethical Guidelines for Clinical Research
Module 08 : Safety Definitions and Adverse Event reporting requirements
Module 09 : Clinical Trials Monitoring at site
Module 10 : Project Management in Clinical Trials
Module 11 : Information Technology tools, AI in Clinical Trial Management
Module 12 : Safety and Hygiene at Clinical Trial site and workplace
Module 13 : Soft Skills & Business Writing