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
None
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.
- 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.
Successful completion of this degree may lead to employment in a variety of different occupations and industries. Below are examples of related occupations with associated Arizona-based wages* for this degree. 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. You can click on any occupation to view the detail regarding education level, wages, and employment information.
* Career and wage information provided by Pipeline AZ using data, reports, and forecasts which are generated using government data sources. Sources
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 Degree Progress Report 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.
- Consult with your faculty mentor or academic advisor to determine educational requirements, including possible university transfer options, for your chosen career field.
Full-time Sequence
Full-time status is 12 credits to 18 credits per semester.
Term 1
Course Number | Course Name | Requisites | Notes | Area | Credits |
---|---|---|---|---|---|
BPC110 or CIS105 |
Computer Usage and Applications or Survey of Computer Information Systems | CS or CS | 3 | ||
CRC101 | Introduction to Clinical Research | Gateway course | 4 | ||
CRC102 | Clinical Research Regulations | 4 | |||
ENG101 or ENG107 |
First-Year Composition or First-Year Composition for ESL | FYC or FYC | 3 | ||
FYE101 or FYE103 |
Introduction to College, Career and Personal Success or Exploration of College, Career and Personal Success | 1–3 | |||
PSY101 | Introduction to Psychology | SB | 3 |
Term 2
Course Number | Course Name | Requisites | Notes | Area | Credits |
---|---|---|---|---|---|
ENG102 or ENG108 |
First-Year Composition or First-Year Composition for ESL | FYC or FYC | 3 | ||
COM100 or COM110 or COM225 or COM230 |
Introduction to Human Communication or Interpersonal Communication or Public Speaking or Small Group Communication | Required for Specialization:2 | SB or SB or L or SB | 3 | |
CRC103 | Research Design and Data Management | 4 | |||
CRC151 | Introduction to Medical Devices in Clinical Evaluation | 2 | |||
HCC145 or HCC146 |
Medical Terminology for Health Care Professionals or Common Medical Terminology for Health Care Professionals | OR Permission of Program Director | 0–3 | ||
CRE101 | College Critical Reading and Critical Thinking | OR Equivalent as indicated by assessment | L | 0–3 | |
BIO160 or BIO201 |
Introduction to Human Anatomy and Physiology or Human Anatomy and Physiology I | If BIO201 is selected, BIO202 will need to be completed | SQ or SG | 4 |
Term 3
Course Number | Course Name | Requisites | Notes | Area | Credits |
---|---|---|---|---|---|
CRC152 | Research Ethics | 3 | |||
CIS114DE | Excel Spreadsheet | 3 | |||
HES210 | Cultural Aspects of Health and Illness | C, G | 3 | ||
HU | Humanities, Arts and Design | Any approved general education course in the Humanities, Arts and Design area. | 3 | ||
MA | Mathematics | Any approved general education course in the Mathematics area Recommend MAT14+ or MAT15+ for students seeking university transfer |
MA | 3–6 | |
BIO202 | Human Anatomy and Physiology II | If BIO201 is selected, BIO202 will need to be completed | SG | 0–4 |
Term 4
Course Number | Course Name | Requisites | Notes | Area | Credits |
---|---|---|---|---|---|
CRC153 | Institutional Review Board in Clinical Research | 3 | |||
CRC160 | Clinical Research Site Management | 4 | |||
PHY101 or PHY111 |
Introduction to Physics or General Physics I | SQ or SQ | 4 | ||
Specialization | Specialization Option | 0–3 | |||
Specialization | Specialization Option | 0–3 | |||
Specialization | Specialization Option | 0–3 |
Gateway Course = Generally the first major-specific course in a pathway.
- C = Cultural Diversity in the US
- CS = Computer/Statistics/Quantitative Application
- FYC = First Year Composition
- G = Global Awareness
- HU = Humanities, Fine Arts, and Design
- L = Literacy & Critical Inquiry
- MA = Mathematics
- SB = Social-Behavioral Sciences
- SG = Natural Sciences General
- SQ = Natural Sciences Quantitative
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/freeForm13?id=186783).
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.