Clinical Research Coordination

The Certificate of Completion (CCL) 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.

The Clinical Research Coordination program has been developed in accordance with standards of the Society of Clinical Research Associates (SoCRA) and the Association of Clinical Research Professionals (ACRP) for their nationally and internationally recognized CRC certification examinations. Course components such as research ethics and Institutional Review Board operations, are based on the standards and guidelines of the Public Responsibility in Medicine and Research (PRIMR). In addition, all course offerings have incorporated domains and competency requirements of the Standards and Guidelines and for the Accreditation of Educational Programs in Clinical Research effective on January 1, 2020.

Details

Field of Interest
Health Sciences
Degree Type
Certificate of Completion (CCL)
Academic Plan
Clinical Research Coordination (CER)
Academic Plan Code
5901
Total credits required
32-33
Catalog Year
2023-2024
Effective Term
Fall 2023
Admissions criteria

1. Formal application to the Clinical Research Coordination program.
2. Formal admission to the Clinical Research Coordination program.
3. Background Check Requirements: Admission to an Allied Health program requires that students be in compliance with the Maricopa County Community College District Background Check standards. Upon conditional program enrollment, the student must comply with all requirements of the MCCCD background check policy.
4. Clinical Health and Safety requirements must be met. Upon conditional program enrollment, the student must comply with all requirements of the MCCCD clinical health and safety policy.
5. Inability to comply with Background Check requirements and/or Clinical Health and Safety requirements at the start of classes may result in cancellation of enrollment for the research clinical experience.

Notes

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

What You'll Learn

This pathway map will help you gain the expertise needed to:

  1. Design a clinical trial (identify the components of a clinical trial protocol).
  2. Differentiate among the five major regulatory bodies governing human subject research.
  3. Describe the role and process for monitoring of the study.
  4. Identify ethical issues of using vulnerable populations in research.
  5. Explain the Institutional Review Board (IRB) review criteria for expedited, minimal risk, and exempt studies.
  6. 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.
  7. Apply management concepts and effective training methods to manage risk and improve quality in the conduct of a clinical research study.
  8. Identify required research protocol components.
  9. 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.
  10. Describe the ethical issues involved when dealing with vulnerable populations and the need for additional safeguards.
  11. Prepare a sample study budget for a clinical trial.
  12. Practice moral reasoning in scientific research.
  13. Summarize at least three confidentiality issues with genetic research.
  14. Summarize the legislative and regulatory framework which supports the development and registration of medicines, devices and biological and ensures their safety, efficacy and quality.
  15. Prepare basic quality assurance procedures for a research site.
  16. Differentiate responsibilities of the IRB, the principal investigator, and the sponsor in the conduct of an investigational device study.
  17. 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.
  18. 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.
  19. Differentiate at least four legal issues facing IRBs.

Successful completion of this certificate may lead to employment in a variety of different occupations and industries. Below are examples of related occupations with associated Arizona-based annual median wages* for this program. Education requirements vary for the occupations listed below, so you may need further education or degrees in order to qualify for some of these jobs and earn the related salaries. Please visit with an academic advisor and/or program director for additional information.

* Wage information sourced from the Bureau of Labor Statistics, Occupational Employment Statistics Program. Updated May 2022.

Course Sequence by Term

The following is the suggested course sequence by term. Please keep in mind:

  • Students should meet with an academic advisor to develop an individual education plan that meets their academic and career goals. Use the Pathway Planner tool in your Student Center to manage your plan.
  • The course sequence is laid out by suggested term and may be affected when students enter the program at different times of the year.
  • Initial course placement is determined by current district placement measures and/or completion of 100-200 level course and/or program requirements.
  • Degree and transfer seeking students may be required to successfully complete a MCCCD First Year Experience Course (FYE) within the first two semesters at a MCCCD College. Courses include FYE101 and FYE103. Course offerings will vary by college. See an academic, program, or faculty advisor for details.

Full-time Sequence

Full-time status is 12 credits to 18 credits per semester.

Term 1

A sequence of suggested courses that should be taken during Term 1
Course Number Course Name Requisites Notes Area Credits
CIS114DE Excel Spreadsheet 3
CRC101 Introduction to Clinical Research 4
CRC102 Clinical Research Regulations 4
HCC145 or
HCC146
Medical Terminology for Health Care Professionals or Common Medical Terminology for Health Care Professionals 2–3

Term 2

A sequence of suggested courses that should be taken during Term 2
Course Number Course Name Requisites Notes Area Credits
CRC103 Research Design and Data Management 4
CRC104 Clinical Data Coordination Practicum I 1
CRC151 Introduction to Medical Devices in Clinical Evaluation 2
CRC152 Research Ethics 3
CRC153 Institutional Review Board in Clinical Research 3

Term 3

A sequence of suggested courses that should be taken during Term 3
Course Number Course Name Requisites Notes Area Credits
CRC160 Clinical Research Site Management 4
CRC204 Clinical Research Coordination Practicum II 2
Disclaimer

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

Course Sequence total credits may differ from the program information located on the MCCCD curriculum website due to program and system design.

View MCCCD’s official curriculum documentation for additional details regarding the requirements of this award (https://aztransmac2.asu.edu/cgi-bin/WebObjects/MCCCD.woa/wa/freeForm11?id=180671).

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.