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Clinical Research Associate

Clinical Research Associate
Instructional Delivery
89
Learning & Comprehension
95
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93

About the Course

Clinical Research Associate (CRA) – 80 hours

This course is designed and offered to the professionals interested to serve as Clinical Research Associates in clinical trials. Clinical Research Associates work under the supervision of Principal Investigator to organize, coordinate and administer clinical research trials. The course includes range of topics such as; foundations of clinical research, research design and data management, ethics, good clinical practices(GCP), site selection and site initiation, patient recruitment, drug development processes, medical terminology, and legal and regulatory compliance. The format will be lecture based but designed to engage in case based discussion and active participation. Students will be assigned a drug development topic which they will research and present during the last session of the course. Students will practice with documentation and data forms.

Course Objectives

At the end of the course, students will be able to :

  • Discuss the role the CRA plays in the drug development process;
  • State the “letter” and the “spirit” of FDA regulations, and ethical considerations pertinent to conducting clinical trials;
  • Select qualified  investigators;
  • Prepare for and conduct Site Selection/Qualification, Site Initiation, Routine Monitoring, and Study Close­ out Visits;
  • Manage and report adverse events (AEs); and
  • List study documentation requirements and standards for  collecting and  reporting clinical trial data.
Course Modules

There are 10 modules, each broken into two parts and covered in 8 contact hours, totaling 80 hours.

 

Module No. Description Hours
Module 1 Overview of Drug Development, FDA & ICH GCP 8 Hours
Module 2 The Clinical Research Team: Roles & Responsibilities 8 Hours
Module 3 The Site Selection Process & Site Qualification Visits 8 Hours
Module 4 IRB/IECs & The Approval Process 8 Hours
Module 5 Study Subject Recruitment, and the Informed Consent Document & Process 8 Hours
Module 6 Investigator’s,Meetings & Study Initiation Visits 8 Hours
Module 7 Managing & Reporting Adverse Events 8 Hours
Module 8 Investigational Product Accountability & Essential Documents 8 Hours
Module 9 Routine Monitoring Visits & Source Data Verification 8 Hours
Module 10 Clinical Data Management Overview, Trip Reports and,Study Close-out Visits
-Monitoring Simulation Exercise
8 Hours
Scope & Job Market

Please visit the following websites to know about current CRA job openings.

http://indeed.com

http://dice.com

http://monster.com

Registration Now Open!

Phone: 1-732-638-5070
Fax: 1-732-638-5274
40, New Brunswick Ave. Perth Amboy, NJ 08861, US