Clinical Research Coordination

The Associate in Applied Science (AAS) in Clinical Research Coordination requires coursework which covers research investigation site management, study coordinator related activities, subject participation coordination, and regulatory documentation and administration. The program focus is on the achievement of behavioral competencies and technical skills for Clinical Research Coordinators (CRC) including essential documentation identification and preparation; subject screening, enrollment, recruitment, and follow-up visits; maintenance, dispensing and documentation of investigational product; completion of case report forms and ancillary regulatory documents; and the adherence to International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines.

Details

Field of Interest
Health Sciences
Degree Type
Associate in Applied Science (AAS)
Academic Plan
Clinical Research Coordination (DEG)
Academic Plan Code
3901
Total credits required
60-75
Catalog Year
2025-2026
Effective Term
Fall 2025
Admission criteria

None

Notes

Students must earn a grade of C or better in all courses within the program.

Students are encouraged to speak with an Academic Advisor or Program Director before starting the program.

What You'll Learn
  • Design a clinical trial (identify the components of a clinical trial protocol).
  • Differentiate among the five major regulatory bodies governing human subject research.
  • Describe the role and process for monitoring of the study.
  • Identify ethical issues of using vulnerable populations in research.
  • Explain the Institutional Review Board (IRB) review criteria for expedited, minimal risk, and exempt studies.
  • Differentiate the types and identification process of adverse events (AEs) which occur during clinical trials and the reporting requirements to IRBs, Ethics Committees, other regulatory authorities, and sponsors.
  • Apply management concepts and effective training methods to manage risk and improve quality in the conduct of a clinical research study.
  • Identify required research protocol components.
  • Explain the evolution of the requirement for informed consent from research participants and the principles and content of the key document which ensure the protection of human participants in clinical research.
  • Describe the ethical issues involved when dealing with vulnerable populations and the need for additional safeguards.
  • Prepare a sample study budget for a clinical trial.
  • Practice moral reasoning in scientific research.
  • Summarize at least three confidentiality issues with genetic research.
  • Summarize the legislative and regulatory framework which supports the development and registration of medicines, devices and biological and ensures their safety, efficacy and quality.
  • Prepare basic quality assurance procedures for a research site.
  • Differentiate responsibilities of the IRB, the principal investigator, and the sponsor in the conduct of an investigational device study.
  • Define significant risk (SR) and non-significant risk (NSR) and explain the role of the IRB, the FDA and the sponsor in determining this status.
  • Compare and contrast the routes to market for device manufacturers, including premarket approval (PMA), substantial equivalence, exemption from 510k, extension of a product line, reclassification and humanitarian use.
  • Differentiate at least four legal issues facing IRBs.
  • Apply relevant knowledge, skills, and habits of mind to seek career opportunities in the field.
Required Courses
Course # Course Title Credits
Credits: 34-39
CIS114DE Excel Spreadsheet 3
CRC101 Introduction to Clinical Research 4
CRC102 Clinical Research Regulations 4
CRC103 Research Design and Data Management 4
CRC151 Introduction to Medical Devices in Clinical Evaluation 2
CRC152 Research Ethics 3
CRC153 Institutional Review Board in Clinical Research 3
CRC160 Clinical Research Site Management 4
HCC145 Medical Terminology for Health Care Professionals (3) OR
HCC146 Common Medical Terminology for Health Care Professionals (2) OR
Permission of Program Director (0) 0-3
HES210 Cultural Aspects of Health and Illness 3
BPC110 Computer Usage and Applications (3) OR
CIS105 Survey of Computer Information Systems (3) 3
FYE101 Introduction to College, Career and Personal Success (1) OR
FYE103 Exploration of College, Career and Personal Success (3) 1-3
Restricted Electives
Course # Course Title Credits
Credits: 0-9
Students should contact an advisor or Program Director to determine if a specialization is needed.
Specialization 1: Clinical Research Coordination
Complete up to three (3) courses listed below for a total of zero to nine (0-9) credit hours:
HES100 Healthful Living 3
CIS117DM Microsoft Access: Database Management 3
CIS150 Programming Fundamentals 3
Specialization 2:Transfer to NAU, Interdisciplinary Studies Strategic Leadership, Bachelor
Select one (1) Oral Communications course (in addition to COM225 in the General Education Requirements below):
COM100 Introduction to Human Communication (3) OR
COM110 Interpersonal Communication (3) OR
COM230 Small Group Communication (3) 3
Any approved general education courses in the Humanities, Arts and Design [HU] area (in addition to the General Education Requirements below). 3
Any approved general education courses in the Social-Behavioral Sciences [SB] area (in addition to PSY101 in the General Education Requirements below). 3
Specialization 3:Transfer to ASU, Applied Science (Health Sciences), Bachelor
No additional coursework needed

At Maricopa, we strive to provide you with accurate and current information about our degree and certificate offerings. Due to the dynamic nature of the curriculum process, course and program information is subject to change. As a result, the course list associated with this degree or certificate on this site does not represent a contract, nor does it guarantee course availability. If you are interested in pursuing this degree or certificate, we encourage you to meet with an advisor to discuss the requirements at your college for the appropriate catalog year.

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