MCCCD Program Description

Major: 5639N Catalog Year: 2023-2024 Effective Term: 2014 Spring Last Admit Term: 2016 Summer Award: CCL Total Credits: 16 CIP Code: 51.0719	Primary College: Initiating College: Gateway Community College Program Availability: Not Found Program Availability: College-Specific Program Availability: College-Specific Field of Interest: Not Found Instructional Council: Applied Technology (57) GPA: 2.00
SOC Code: 29-2010

Description: The Certificate of Completion (CCL) in Clinical Research Associate (CRA) program is an advanced career track certificate for those who desire to become Research Monitors. It is designed to train Clinical Research Coordinators (CRCs) or other health-related professionals to transition into the CRA role. While the CRC typically works at research investigative sites, hospitals, and research institutes; the CRA is based within the Pharmaceutical, Biotechnology and Medical Device Industries.

This program offers courses focused on the fundamental competencies of a Clinical Research Associate, providing entry level courses that train individuals who wish to expand their health related or other medical background experience.

Suggested Course Plan Sequenced by Semester

Required Courses

+ CRA290 Introduction to Clinical Research Associate 3
+ CRA291 Monitoring 4
+ CRA293 Clinical Study Development 3
+ CRA295 Ethics and Regulations 3
+ CRA297 Clinical Trial Material and Device Accountability 3

Credits: 16

Restricted Electives
	Credits:

General Electives
	Credits:

Program Competencies
1. Prepare a monitoring plan based on a study timeline. (CRA290, CRA291) 2. Audit a subject chart for protocol/regulatory compliance. (CRA290, CRA291) 3. Develop a Clinical Research Associate tool chest to assist in monitoring. (CRA290, CRA291) 4. Design a study and site recruitment strategy. (CRA291) 5. Utilize electronic systems and external resources to provide relevance to everyday functions of the CRA. (CRA291) 6. Present a CRA to Site training modules for the following; Site Initiation Visit, Routine Monitoring and Audit Preparation. (CRA291) 7. Describe potential conflicts with sites and sponsors and create a resolution plan. (CRA291, CRA295) 8. Discuss the key personnel in the study design process. (CRA293) 9. Create a device study plan based on a study timeline. (CRA293) 10. Compare and contrast the study design role of the CRA across therapeutic disciplines. (CRA290, CRA293) 11. Design a study plan timeline for a standard study protocol. (CRA290, CRA293) 12. Describe the significance of the components of an Investigative New Drug (IND) application. (CRA295) 13. Develop a standard regulatory binder to be utilized at a site and sponsor level. (CRA295) 14. Compare and contrast the regulatory differences from the site versus the sponsor perspective. (CRA295) 15. Design regulatory compliant drug and device accountability logs from a site and sponsor perspective. (CRA297) 16. Create a packaging design based upon a study protocol. (CRA297) 17. Compare and contrast the CRA role in drug versus device industry. (CRA297) 18. Prepare career plan for obtaining initial CRA position and career advancement. (CRA290) 19. Apply Good Clinical Practice (GCP) guidelines and regulatory processes to the CRA role. (CRA290, CRA291, CRA293, CRA295, CRA297)
+ indicates course has prerequisites and/or corequisites. ++ indicates that any suffixed course may be selected. MCCCD Governing Board Approval Date: October 22, 2013

All information published is subject to change without notice. Every effort has been made to ensure the accuracy of information presented, but based on the dynamic nature of the curricular process, course and program information is subject to change in order to reflect the most current information available.