Senior Specialist, Clinical Research Monitoring
$108k - $153kEdwards Lifesciences Corp.
Edwards Lifesciences seeks a Senior Specialist in Clinical Research Monitoring to oversee field monitoring, data collection, and regulatory compliance for cardiovascular clinical trials. The role involves site audits, GCP training, protocol oversight, and device accountability tracking for structural heart disease studies.
Responsibilities
- Conduct field monitoring of clinical trial sites and assess documentation for consistency with study protocols and case report forms
- Develop and deliver GCP training, protocol education, and compliance training to site staff and new employees
- Provide oversight and insights on trial activities to investigators, sponsors, and leadership; identify process improvements
- Contribute to development of clinical protocols, informed consent forms, and case report forms
- Validate and track investigational device accountability and verify trial data integrity and regulatory documentation
Requirements
- Bachelor's degree in related field with 5+ years field monitoring and regulatory compliance experience
- Ability to travel domestically up to 75%
- Clinical research certification (ACRP or SoCRA) preferred
- Strong written and verbal communication and presentation skills
- Proficiency in MS Office Suite and general computer software
- Understanding of cardiovascular anatomy, pathology, and device regulatory requirements
- Technical writing skills for protocols and case report forms
Compensation: $108,000–$153,000 base
Vacancy posted 3 days ago
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