Senior Clinical Research Associate

Senior Clinical Research Associate responsible for overseeing in vitro diagnostic and medical device clinical trials at external sites. Role includes protocol execution, site management, regulatory compliance, and data quality oversight across multiple projects. Position is remote within the United States with 20-70% travel requirement.

Responsibilities

• Oversee clinical study protocol execution at external sites from initiation through close-out with FDA compliance and GCP adherence
• Develop and maintain relationships with institutions, investigators, stakeholders, and vendors to ensure trial execution and data integrity
• Conduct independent site monitoring, manage investigational product accountability, and assess protocol deviations and adverse events
• Manage IRB submissions and regulatory documentation to maintain audit-ready Trial Master Files
• Contribute to study planning including budget negotiation, site qualification, and process improvement initiatives

Requirements

• Bachelor's degree with 5+ years clinical research experience, or Master's with 3+ years, or Doctoral degree with clinical research experience
• Knowledge of regulatory requirements and Good Clinical Practice for IVD and medical device products
• Experience managing clinical research sites and monitoring clinical study data
• Technical background to understand and communicate current and emerging technologies
• Ability to manage multiple concurrent projects
• Willingness to travel 20-70% within the US, including overnight stays

Compensation: $103,000–$130,000 base, eligible for bonus/incentive pay