GENERAL SUMMARY:

• Responsible for keeping clinical research projects in compliance with the Code of Federal Regulations, Sponsor and System guidelines.
• Provide technical support to Principal Investigators.
• Analyze protocol specific requirements and implement quality assurance measures to ensure physician, patient and clinician compliance.
• Abstract medical information from various sources in the patient medical record.
• Report adverse events to medical monitor, FDA, and all other governing bodies.
• Manage all external audits and monitoring visits, and serve as liaison between institution and sponsor.
• Serve as departmental and system-wide resource.
• Manage the hiring, orientation, mentoring, work oversight, disciplinary actions, and performance review processes for the clinical research coordinators.