Clinical Research Associate III

Position Overview:

Site Monitoring & Management

• Independently manage 10-15 investigational sites from start-up through close-out
• Perform all monitoring visits (SIV, IMV, COV) in accordance with the Monitoring Plan
• Ensure compliance with protocol, Monitoring Plan, SOPs, and applicable regulations (ISO 14155, FDA, and local requirements)
• Conduct SDV/SDR, informed consent review, and AE/SAE oversight
• Maintain full ownership of assigned investigator sites, ensuring successful site management and performance
• Build and maintain strong relationships with Principal Investigators and site staff
• Provide training, guidance, and ongoing support to site personnel
• Communicate effectively to manage queries, provide updates, and drive issue resolution
• Ensure data quality, timely query resolution, and site compliance
• Identify risks and support audit and inspection readiness
• Collaborate cross-functionally with Data Management, Clinical, and Project Management teams to support study execution
• Attend Investigator and/or Coordinator meetings

Team Support & Mentorship

• Share expertise and provide guidance to junior CRAs, serving as a resource for questions, problem-solving, and best practices
• Support training initiatives and review work, contributing to team development and consistency across sites
• Provide support to upper management as needed, including contributing to study updates, escalations, and operational decision-making

Qualifications:

• 5+ years of CRA experience
• Strong medical device experience
• Medical device experience, cardiovascular/TEVAR preferred
• Solid understanding of GCP and FDA regulatory requirements
• Ability to work independently and effectively multitask, prioritizing competing activities across multiple sites and study demands
• 50-75% of travel is required for this position.