Global Clinical Operations

Project Management

• Feasibility assessment
• Select and manage investigator sites, including contracts and payments
• Manage timeline, budget and production schedules for all tasks
• Training and oversight of CRAs
• Liaison with other Functional Areas
• Regulatory document processing and review
• Complete documentation of study

Clinical Monitoring

• Site Qualification Visits
• Site Initiation Visits
• Site Monitoring Visits
• Site Close-Out Visits
• Query Management
• Overall site management