Maricopa Community Colleges  CRC230   20046-20076 
Official Course Description: MCCCD Approval: 06/22/04
CRC230 20046-20076 LAB 1 Credit(s) 5 Period(s)
Clinical Research Coordinating Internship
Observation and application of clinical research coordinating skills and functions in various clinical research settings. Eighty (80) hours of clinical research coordinator experience in an approved clinical research setting. Evaluation by site supervisor and college internship coordinator.
Prerequisites: Acceptance into Clinical Research Coordinating program and completion of CRC120.
Course Note: May be repeated for a total of three (3) credits.
 
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MCCCD Official Course Competencies:
 
CRC230   20046-20076 Clinical Research Coordinating Internship
1. Following on-site observation and appraisal, demonstrate the fundamental concepts of clinical research coordinator (CRC) functions in at least 3 different research settings. (I)
2. Appraise the standard operating procedures and adherence to Good Clinical Practices in at least 3 research sites. (I, II)
3. Communicate effectively with site personnel and with faculty internship coordinator. (III)
4. Maintain confidentiality and ethical standards. (IV)
5. Participate in the completion of regulatory forms under the direct supervision of the site supervisor. (V)
6. Observe an informed consent process for a clinical trial subject. (VI)
7. Apply clinical research coordinator skills to work experiences for a total of 80 hours throughout the semester. (I-VI)
8. Accomplish individualized clinical research coordinator related learning objective (s). (I-VI)
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MCCCD Official Course Outline:
 
CRC230   20046-20076 Clinical Research Coordinating Internship
    I. CRC Functions in Research Settings
        A. Hospital
        B. Contract Research Organization
        C. Animal/Pre-clinical and Laboratory Research
        D. Site Management Organizations
        E. Community Physician Research Group Practices
        F. Other
      II. Good Clinical Practices
        III. Communication
            A. Site Personnel and Study Sponsors
            B. Faculty Internship Coordinator
          IV. Confidentiality and Ethical Research Standards
            V. Regulatory Forms
                A. Case Report Forms
                B. Regulatory Binders
                C. Institutional Review Board Submission Packets
                D. Investigational New Drug Safety Reports and Accountability Logs
                E. Serious/Adverse Event Reports
                F. Investigator Brochures/Updates
                G. Sponsor Required Forms
                H. Other
              VI. Informed Consent Process
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