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.). 

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.