Sr. Clinical Research Associate

📋 Description

• Independently plan, conduct, and document on-site and remote monitoring visits, including site
• Apply a risk-based monitoring approach to evaluate site performance, protocol compliance, data
• Conduct comprehensive source data verification (SDV) and source data review (SDR) to ensure Case
• Independently manage day-to-day site relationships, driving enrollment momentum, query resolution
• Proactively identify, assess, and document monitoring findings, site-level risks, protocol
• Prepare and submit timely, high-quality monitoring visit reports and follow-up correspondence that

🎯 Requirements

• Bachelor's degree in a life sciences or health-related field, or equivalent combination of
• 5-8 years of clinical monitoring experience, including independent on-site and remote monitoring
• Experience monitoring studies for diagnostics, in vitro diagnostics (IVD), or regulated medical
• Strong working knowledge of ICH-GCP E6(R2) guidelines, FDA regulations, including 21 CFR Parts 11
• Familiarity with risk-based monitoring (RBM) frameworks and central monitoring methodologies.
• Demonstrated ability to independently manage a portfolio of investigative sites, including

🎁 Benefits

• Work at the edge of what is possible in diagnostics with advanced technologies
• Direct, life-changing impact on patient care at scale
• Remote work flexibility
• Opportunity to mentor junior staff
• Collaborative, mission-driven team