Clinical Research Associate IV

Description

• Participate in the design and development of clinical protocols; design of case report forms and relevant edit checks for clinical studies
• Manage vendors required to conduct clinical studies
• Oversee performance of CROs and field CRAs to ensure compliance
• Identifies, initiates, monitors and closes clinical study sites, ensuring adherence to the protocol providing for accurate data collection
• Prepares and tracks required documentation from clinical sites prior to study start-up
• Reviews informed consents for accuracy and adherence to federal regulations
• Provides patient accruals and projections as required
• Maintains complete and accurate clinical study documentation
• Assists in preparation of clinical study reports, annual progress reports, drug monographs, and interim study analyses

• 25-30 percent travel
• BS/BA in biological or scientific discipline
• Minimum 12 years industry experience
• Vendor, CRO management, and international experience required