Work Schedule
Other
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
Reviews inclusion/exclusion criteria with patients to ensure eligibility to
participate in study. Interacts with Principal Investigator for inclusion/exclusion
review of patient data. Reviews and witnesses the consenting process for
subjects. Prepares study-specific documents for applicable study visit.
• Ensures the safety of patients by monitoring and assessing AEs, if any, and
communicating potentially serious findings to investigators.
• Performs all procedures in the treatment areas (i.e., check-ins, gauze
management, administration of drug, blood draws, ECGs, vital signs, etc.).
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Monitors staff to assure adherence to GCP, ICH, FDA, and OSHA guidelines.
• Attends initiation meetings when necessary to obtain study process clarification.
• Monitors and continuously evaluates the overall research experience of each
patient to assure a positive experience.
• Performs other study-related duties as qualified by documented training.