Senior Specialist, Clinical Research Monitoring
Edwards Lifesciences · Remote
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
This role involves monitoring clinical trials for transcatheter heart valve devices, ensuring data quality and regulatory compliance across study sites. Responsibilities include field monitoring, protocol training, investigator liaison, and regulatory documentation oversight. The position requires a bachelor's degree plus five years of monitoring and compliance experience, with up to 75% domestic travel.
What they're looking for
- Bachelor's degree in related field or equivalent work experience
- 5+ years field monitoring, quality assurance, and regulatory compliance experience
- Ability to travel domestically up to 75%
- Clinical research certification (ACRP or SoCRA) preferred
- Strong written and verbal communication skills
- Proficiency with MS Office Suite and general computer software
- Understanding of medical device regulatory requirements and adverse event reporting
What you'll be doing
- Monitor clinical trials and assess data documentation for consistency with case report forms and study protocols
- Develop and deliver technical training on GCP, protocols, compliance, and device accountability to site staff
- Provide oversight and insights on trial activities to investigators, sponsors, and regulatory bodies
- Contribute to development of clinical protocols, informed consent forms, and case report forms
- Track investigational device accountability from Edwards to field sites through final disposition
Privacy & handoff
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