Course Title: Clinical Research Associate
Course no:109
Credit Hours: 730 Hours

Program Length:
Morning and afternoon classes, 25 hrs. Per week (30 weeks). Night classes, 20 hrs. Per week (37 weeks)

Prerequisites:
Be at least 18 years of age. The student must have at least two years of college or associate degree or equivalent degree to enroll for this program. In addition, you need to pass the BioHealth College entrance exam.

Course Objectives:
The Pharmaceutical and Biotechnology Regulatory Research Associate curriculum prepares the students to work in the bioscience industry in the areas of research and development, Drug business development, Clinical and regulatory affairs.

Catalog Description:
This program allows students to acquire the necessary knowledge to enter the pharmaceutical and biotechnology industry as an entry level clinical research associate.

The student will learn to assist the clinical affairs team of pharmaceutical and biotechnology companies in cross-functional team activities. The student learns to review the processes of clinical trial data to ensure the accuracy and consistency of a clinical trial database, manage and review database building, testing, validation and updating; clinical data coding, review of protocol requirements and project specific requirements. The student will assist the product development teams to insure US and other international regulatory requirements. The student learns to review and reconcile safety data, receive and track adverse events, review patient laboratory data & identify potential safety issues, review medical coding data, and communicate safety issues. In addition, she/he will learn about the process of clinical research and processes including the phase I-II stages and the transitional stage to Regulatory stage and FDA approval. She/he learns to review the processes of clinical trial data to ensure the accuracy and consistency of a clinical trial database, manage and review database building, testing, validation and updating; clinical data coding, review of protocol requirements and project specific requirements. .

Course Outline: Biotechnology Business Management
Introduction to Basic Science & Computer Skills
Introduction to Cell and Molecular Biology
Foundation of Biotechnology and Genetic Engineering
Principles of Business Management
Biotechnology Laboratory Fundamentals
Clinical Reserch I
Clinical Reserch II
Career Development / Job prep