May 19, 2024  
2022-2023 College Catalog 
2022-2023 College Catalog [ARCHIVED CATALOG]

CRC 260IN - Lab Skills and Professional Practice

3 Credits, 5 Contact Hours
2 lecture periods 3 lab periods

Clinical skills training to prepare for clinical research coordinator internship, with emphasis on applying clinical research project coordination concepts and practices in a simulated research setting. Includes research subject communication techniques, medical history review, adverse events, vital signs, EKG procedures, blood collection and specimen processing, storage and shipping. Also includes application of clinical research project coordination practices related to a protocol; research and medical terminology; recruitment, enrollment and retention practices; informed consent; detection of errors within study reports and casework; documentation of medications, adverse events and serious adverse events; review of study subject’s file data for completeness and accuracy; and regulatory and legal mandates related to clinical trials.

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Course Learning Outcomes
  1. Describe principles of good leadership, management, and mentorship.
  2. Describe effective communication methods.
  3. Demonstrate aseptic techniques with the current Center for Disease Control (CDC) guidelines on universal precautions
  4. Demonstrate performance of vital signs.
  5. Demonstrate the process of running a twelve lead electrocardiogram.
  6. Describe clinical research coordinator laboratory processes including IATA procedures for shipping dangerous goods, specimen quality assurance.
  7. Describe body systems as it pertains to phlebotomy, preparation of a patient, equipment used and procedures in drawing blood.
  8. Demonstrate techniques using vacutainer methods and quality assurance standards for phlebotomy
  9. Describe ethical behaviors in the workplace.

  1. Research Subject Communication
    1. Professional communication and behavior
      1. Professional situations
      2. Tact
      3. Diplomacy
      4. Courtesy
      5. Responsibility
    2. Therapeutic relationships
      1. Impartial behavior
      2. Effective responses to cultural differences
      3. Empathy
    3. Recognizing and responding to verbal and nonverbal communication
      1. Positive body language
      2. Listening skills
      3. Eye contact
      4. Barriers to effective communication
      5. Identifying needs of others
    4. Evaluating and understanding communication
      1. Observation
      2. Active listening
      3. Feedback
    5. Interviewing techniques
      1. Interviewee  (subject, family member, other)           
      2. Setting (office, telephone, hospital)
      3. Guiding, controlling and ending interviews
        1. Using questions – exploratory, open-ended, direct
        2. Legal restrictions
  2. Research Subject Encounter
    1. Clinical treatment setting vs. research protocol setting
    2. Subject History
      1. Role of the Principal Investigator
      2. Components of a standard medical chart
    3. Patient Diary
    4. Medication Changes
      1. Subject reporting
      2. Documentation
    5. Adverse Events & Serious Adverse Events
      1. Subject reporting
      2. Documentation
    6. Vital Signs
      1. Performing
        1. Body Temperature
        2. Pulse Rate
        3. Blood Pressure
        4. Respiratory Rate
      2. Recording
  3. Electrocardiography
    1. Review of the anatomy and physiology of the heart
    2. Function of the EKG machine
    3. Proper use of the EKG machine
    4. Normal anatomy of the chest wall for proper lead placement
    5. Lead placement and other clinical practices
    6. Practicing EKG
  4. Clinical Research – Laboratory
    1. Laboratory Issues for Clinical Research
      1. Role of the Clinical Research Coordinator
      2. Variety of clinical trial settings
      3. Laboratory specifications within study protocols
    2. Phlebotomy - blood collecting
      1. Review of the circulatory system
      2. Veins suitable for phlebotomy
      3. Minimizing biohazard exposure
      4. OSHA safety standards
      5. Blood collecting equipment and supplies
      6. Preparing subjects for blood collection & proper infection control
      7. Steps in venipuncture process
      8. Complications associated with blood collection
      9. Proper postpuncture care
      10. Practicing venipuncture on medical mannequins
    3. Specimen Processing, Storage and Shipping
      1. Quality assurance and control
      2. Proper disposal of needles, sharps and medical waste
      3. Appropriate procedures for processing blood containers
      4. Infectious substance shipping guidelines per IATA procedures