Clinical Research Associate
CIP CODE: 51.1005
12 months Full-Time; 24 months Part-Time
796 Instruction Hours
Program Description
Describe the medical product path starting with discovery and ending with marketing approval. Identify the GCP obligations in protecting the rights of study subjects. Distinguish the different roles and GCP obligations between the Investigator, Sponsor, and IRB. Explain the ‘ideal’ elements used in coordinating a clinical trial. Demonstrate the ability to perform monitoring and coordinating activities and detect GCP deficiencies. Choose the different problem-solving techniques in resolving GCP deficiencies
Course Content
CTR110 Introduction to Clinical Research
(45 Instruction Hours)
This course provides a comprehensive introduction to the clinical research process and its history and evolution. Topics include phase of clinical trials, protection of human subjects, roles of the clinical research teams, and responsibilities of clinical research organizations. Upon completion, students should be able to prepare an organizational chart depicting a typical research team, defining the roles or responsibilities of each member. The student should also be able to describe the product approval process and discuss the general conduct of a typical clinical trial.
CTR112 Clinical Research Terminology
(60 Instruction Hours)
This course is designed to enhance and augment the student’s knowledge of basic medical terminology. Emphasis is on acronyms, abbreviations, and initials commonly used in clinical research and the terminology associated with pharmaceutical and pharmacological research. Upon completion, students will be able to utilize and apply standard research terminology in effective written and verbal communication.
Prerequisite: CTR 110