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.
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
29-30
Effective Term
Spring 2024
Notes
Students must earn a grade of C or better in all courses within the program.
What You'll Learn
- Design a clinical trial (identify the components of a clinical trial protocol). (CIS114DE, CRC103, CRC151, HCC145, HCC146)
- Differentiate among the five major regulatory bodies governing human subject research. (CRC102)
- Describe the role and process for monitoring of the study. (CIS114DE)
- Identify ethical issues of using vulnerable populations in research. (CRC102, CRC152, HCC145, HCC146)
- Explain the Institutional Review Board (IRB) review criteria for expedited, minimal risk, and exempt studies. (CRC101, CRC102, CRC153)
- 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. (CIS114DE, CRC152, CRC153, HCC145, HCC146)
- Apply management concepts and effective training methods to manage risk and improve quality in the conduct of a clinical research study. (CIS114DE, CRC152)
- Identify required research protocol components. (CIS114DE, CRC101, CRC103, HCC145, HCC146)
- 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. (CIS114DE, HCC145, HCC146)
- Describe the ethical issues involved when dealing with vulnerable populations and the need for additional safeguards. (CRC101, CRC152, HCC145, HCC146)
- Prepare a sample study budget for a clinical trial. (CIS114DE)
- Practice moral reasoning in scientific research. (HCC145, HCC146)
- Summarize at least three confidentiality issues with genetic research. (CRC152, HCC145, HCC146)
- Summarize the legislative and regulatory framework which supports the development and registration of medicines, devices and biological and ensures their safety, efficacy and quality. (CRC102, HCC145, HCC146)
- Prepare basic quality assurance procedures for a research site. (CIS114DE, CRC160)
- Differentiate responsibilities of the IRB, the principal investigator, and the sponsor in the conduct of an investigational device study. (CRC153)
- 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. (CRC153, HCC145, HCC146)
- 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. (CRC151, CRC152)
- Differentiate at least four legal issues facing IRBs. (CRC153)
| Course # | Course Title | Credits |
|---|---|---|
| Credits: | 29-30 | |
| 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) | 2-3 |
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.