GENERAL SUMMARY:

• Under supervision, coordinates low-moderate complexity clinical research projects in compliance with the Code of Federal Regulations.
• Provides technical support to Principal Investigators.
• Analyzes protocol specific requirements and implements measures to ensure physician, patient and clinician compliance.
• Reviews medical record and compiles data into sponsor provided database in support of the primary endpoint of the clinical trial.
• Identifies and reports adverse events to medical monitor, FDA, and all other governing bodies.
• Coordinates all external audits and monitoring visits, and serves as liaison between institution and sponsor.
• Serves as departmental and system-wide resource.