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T45 Labs1 day ago

Sr. Clinical Research Associate - VahatiCor

Remote · United States

Type
Full Time
Level
Senior Level
Education
Bachelors Degree
Company size
Startup

Job Summary

Sr. Clinical Research Associate at VahatiCor responsible for owning site activation, startup, site management, enrollment performance, and protocol execution across cardiovascular clinical studies. Serves as the primary operational partner to clinical sites, driving site readiness, investigator engagement, enrollment success, and compliant protocol execution throughout the study lifecycle. Collaborates with Clinical Trials Manager, study leadership, Regulatory, Quality, and Data Management to ensure FDA/GCP compliance, training, monitoring, and timely study milestones. Requires extensive clinical operations experience, especially in catheter-based cardiovascular medical device studies, and willingness to travel up to 60%. Remote position supporting sites throughout the Eastern United States; travel to sites as needed.

Required Qualifications

  • Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, or related scientific discipline
  • 7+ years of clinical research experience in the medical device industry
  • Experience owning site startup, activation, enrollment, and clinical trial execution activities
  • Experience owning site qualification, initiation, monitoring, and site management activities
  • Experience with catheter-based cardiovascular medical device studies preferred
  • Demonstrated understanding of FDA regulations, ICH/GCP, and clinical research operations
  • Strong written and verbal communication skills
  • Ability to travel up to 60%
  • Ability to work in dynamic, fast-paced environment with initiative and collaboration
  • Authorized to work in the United States without visa sponsorship

Additional Requirements

  • Must be permanently authorized to work in the United States without the need for current or future visa sponsorship.
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T45 Labs

Sr. Clinical Research Associate - VahatiCor

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