Job Title: Senior Clinical Research Associate (Sr. CRA)
Location: Remote (Eastern or Central Time Zone, U.S.)
Travel: ~50%
About the Role
We are seeking an experienced Senior Clinical Research Associate (Sr. CRA) to support clinical trials for an innovative cardiovascular medical device portfolio. This individual will play a critical role in ensuring the successful execution of clinical studies, maintaining compliance with regulatory requirements, and driving high-quality data collection across investigative sites.
Key Responsibilities
- Independently manage all aspects of site monitoring activities, including site qualification, initiation, routine monitoring, and close-out visits
- Oversee approximately 10 clinical trial sites, ensuring adherence to study protocols, GCP, and applicable regulatory requirements
- Build and maintain strong relationships with investigators and site staff to support enrollment, retention, and overall study success
- Perform source data verification (SDV) and ensure data integrity, accuracy, and completeness
- Identify, document, and resolve protocol deviations, data queries, and site performance issues
- Provide site training and ongoing support for study-related procedures and compliance expectations
- Collaborate cross-functionally with Clinical Operations, Data Management, Regulatory, and Medical Affairs teams
- Assist with site management responsibilities, including tracking site performance metrics and supporting risk mitigation strategies
- Contribute to study documentation, including monitoring reports, trip reports, and audit readiness activities
Qualifications
- Bachelor’s degree in life sciences, nursing, or related field
- 4+ years of clinical monitoring experience, with at least 1–2 years in a senior-level or lead CRA capacity
- Experience in cardiovascular studies and/or medical device trials strongly preferred
- Strong knowledge of ICH-GCP guidelines, FDA regulations, and clinical trial processes
- Proven ability to manage multiple sites and prioritize workload effectively
- Excellent communication, organizational, and problem-solving skills
- Ability to travel up to 50% as required
Preferred Qualifications
- Experience with complex interventional cardiovascular device trials (e.g., structural heart, electrophysiology, or vascular interventions)
- Prior involvement in site management or mentoring junior CRAs
- Experience working in a fast-paced, growth-stage company environment
What We Offer
- Competitive salary and performance-based incentives
- Comprehensive benefits package (medical, dental, vision, 401k, etc.)
- Opportunity to work on cutting-edge cardiovascular technologies that improve patient outcomes
- Collaborative, mission-driven culture with strong growth potential
Equal Opportunity Employer
We are committed to building a diverse and inclusive workplace and welcome applicants from all backgrounds.
If you’re a driven CRA looking to take the next step in your career and make a meaningful impact in cardiovascular innovation, we encourage you to apply.
