Program Details
Career Studies Certificate in Clinical Research Coordinator
Career Studies CertificateMountain Empire Community College
The Clinical Research Coordinator Certificate is designed to provide entry-level specialization in the clinical trial operations. The Clinical Research Coordinator supports, facilitates and coordinates clinical trial activities and plays a critical role in managing the clinical trial. The curriculum provides introduction to clinical trials in phases 1-5, obtaining informed consent, educating the patient on the clinical trial process, risks and benefits while ensuring Good Clinical Practice Standards are followed. The Clinical Research Coordinator reports to the Principle Investigator and the Institutional Review Board and manages the recruitment and retention of objects for clinical trial while ensuring vulnerable subjects are protected from risk. Clinical Trials consist of research for pharmacologics, investigational devices, biologics and social/behavior studies. Students will also learn the sources of data collection, source documents and case forms used in the clinical research process, as well as privacy, security and confidentiality protocols.
Outcomes
Upon successful completion, students will be able to:
1. Explain the roles of the clinical research team, their specific roles and legal requirements.
2. Examine the Drug Development Process regarding the definitions, regulations and process for investigational new drug (IND) and new drug applications (NDA).
3. Analyze the drug, device and biologic development process, including protocol development, case form report development, feasibility of the clinical trial and developing a budget for clinical study.
4. Examine and evaluate the use of Code of Federal Regulations in the clinical trial process.
5. Explain adverse and severe drug reactions and adverse events, evaluate the process of the Institutional Review Board notification of adverse events.
6. Discuss procedural and management issues regarding utilization and disposition of informed consent and source documents.
7. Develop recruitment plans using healthcare marketing strategies and retention plans for clinical trials using informed consent and the community of interest.
8. Examine research ethics through therapeutic and disease misconceptions, understanding bias and randomization.
9. Apply the concepts of Good Clinical Practice and understand the International Conference on Harmonization.
Program Overview & Guidance

Program Guidance Element | What You Need to Know |
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Considerations for Selecting Degree | The Clinical Research Coordinator Certificate is designed to provide entry-level specialization in the clinical trial operations. The Clinical Research Coordinator supports, facilitates and coordinates clinical trial activities and plays a critical role in managing the clinical trial. Clinical Trials consist of research for pharmacologics, investigational devices, biologics and social/behavior studies. |
Considerations When Selecting Courses |
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Program Requirements Beyond Specific Courses | The curriculum provides introduction to clinical trials in phases 1-5, obtaining informed consent, educating the patient on the clinical trial process, risks and benefits while ensuring Good Clinical Practice Standards are followed. Students will also learn the sources of data collection, source documents and case forms used in the clinical research process, as well as privacy, security and confidentiality protocols. |
Doing More With Your Degree | Employers are increasingly looking for clinical trials staff with a developed set of core competencies such as data classification, health informatics and healthcare statistics. |
Program Successes & Highlights |
Program Credit Requirements

Please note that some courses may count towards more than one requirement such as meeting a general education requirement and a major specific requirement. The course will be listed under the first matching requirement. Please contact the institution with questions.
A formal determination of credits awarded for your prior learning and their applicability to the degree requirements can only be made by the institution. The formal determination and resulting map may reflect higher or lower number of credits to be completed to achieve this program.
What If I Have An Associate Degree Or Credit For Prior Learning?

Transfer Guidance Element | What You Need to Know |
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Associate Transfer Degree Completion | The transfer education program, which includes freshman and sophomore courses in arts and sciences and pre-professional education, allows students to transfer into baccalaureate degree programs and four-year colleges and universities. |
Completion of Associate Degree Concurrent with High School | The transfer education program, which includes freshman and sophomore courses in arts and sciences and pre-professional education, allows students to transfer into baccalaureate degree programs and four-year colleges and universities. |
Credit for Prior Learning | VCCS Policy 5.6.5.1 |
Did You Know That... |
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College Level Information

College Fit Guidance | What You Need to Know |
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Is This College Right For Me? | Mountain Empire Community College’s mission is to provide our region with accessible, quality higher education, workforce training, and community programs to ensure an educated population and globally competitive workforce. |
Transfer Student Catalog Year | |
First Year Student Catalog Year | The catalog year is based on the admission term that the student applies for. |
Applying for Guaranteed Admissions |
Where Can This Degree Transfer

If you are interested in transferring to a four-year degree view this degree on the Transfer Virginia site to explore degrees aligned with this program at Virginia's 4-year institutions.
Institution | Title | Degree | Award Name | Award Level | Delivery Mode |
---|---|---|---|---|---|
Laurel Ridge Community College | Associate of Applied Science Degree in Health Information Management | Associate | Associate of Applied Science | 2-Year | Online |
Northern Virginia Community College | Health Information Management, A.A.S. | Associate | Associate of Applied Science | 2-Year | In-Person, Hybrid |
Tidewater Community College | Associate of Applied Science - Health Information Management | Associate | Associate of Applied Science | 2-Year | Online |
Careers Where This Degree Applies

O*Net Code | Name | Description | Parent |
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29-9021.00 | Health Information Technologists and Medical Registrars | Apply knowledge of healthcare and information systems to assist in the design, development, and continued modification and analysis of computerized healthcare systems. Abstract, collect, and analyze treatment and followup information of patients. May educate staff and assist in problem solving to promote the implementation of the healthcare information system. May design, develop, test, and implement databases with complete history, diagnosis, treatment, and health status to help monitor diseases. | Healthcare Practitioners and Technical Occupations |
29-2072.00 | Medical Records Specialists | Compile, process, and maintain medical records of hospital and clinic patients in a manner consistent with medical, administrative, ethical, legal, and regulatory requirements of the healthcare system. Classify medical and healthcare concepts, including diagnosis, procedures, medical services, and equipment, into the healthcare industry's numerical coding system. Includes medical coders. | Healthcare Practitioners and Technical Occupations |
Cost To Complete

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