Lead CRA

Remote Lead CRA role with a mid-sized CRO 

Responsibilities:

• Oversees performance of assigned field monitors and site activities in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and federal regulations
• Implementation of recruitment and enrollment strategies 
• Assistance in vendors’ selection process
• Development, execution, management and compliance assurance of the monitoring plan
• Review and approve trip reports, track scheduling, report submission metrics, site deviations, and action items
• Oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation, and corrective actions
• Development of training materials and study tools for site and CRA use

Qualifications: 

• 3-5 years of Cardiovascular Therapeutic experience
• Nephrology and Renal experience preferred  
• 1 ½- 2 years of Lead CRA experience
• Min. 6 years of CRA experience
• Up to 25% travel
• Phase II and Phase III experience
• B.S. Degree minimum