Clinical Research Monitoring Specialist

🔥 14 hours ago

🏄 California – Remote

🏄 California – Remote

💵 $87k - $123k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Edwards Lifesciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1958

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Edwards Lifesciences is a global leader in patient-focused medical innovations. The company specializes in heart valve disease solutions, offering products and services such as transcatheter heart valves and mitral and tricuspid technologies, as well as surgical heart valve solutions. Edwards Lifesciences also focuses on critical care technologies including hemodynamic monitoring, remote monitoring, and predictive monitoring. The company conducts clinical research and is committed to improving patient lives through innovative cardiovascular disease solutions, while being a responsible corporate citizen with an emphasis on global corporate giving.

📋 Description

• Conduct field monitoring of studies and data collection for clinical trials • Assess data documentation, reports, records, transcripts, and exam results for consistency with case report forms • Determine whether clinical trial/study subject documentation aligns with the study hypothesis • Monitor clinical trial/study safety in accordance with protocols, GCP, and regulatory requirements • Provide oversight and insights into trial activities, including protocol compliance, enrollment, monitoring deviations, and data quality • Report findings to principal investigators, support staff, sponsor management, leadership, Institutional Review Boards/Ethics Committees, Research Ethics Committees, and Clinical Operations • Recommend and develop process improvements • Verify trial/study data and maintain appropriate internal and external regulatory documents • Audit sites for appropriate regulatory documentation and proper source documentation • Validate investigational device accountability from Edwards through field sites and final disposition • Develop and deliver training on GCPs, protocols, databases, compliance, device accountability, adverse event reporting, investigation protocols, amendments, and regulatory documentation • Train and proctor new employees on trial- and study-related activities

🎯 Requirements

• Bachelor's Degree or equivalent in related field • 3 years of field monitoring, quality assurance/control and regulatory compliance experience or equivalent work experience based on Edwards criteria • Ability to travel up to 75% domestically • Clinical research certification (ACRP or SoCRA clinical coordinator / CRA certification) preferred • Strong written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills • Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery • Demonstrated problem-solving and critical thinking skills • Strong understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise • Substantial understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting • Technical writing skills (protocols, CRF development, study tools) • Ability to communicate and relate well with key opinion leaders and clinical personnel

🏖️ Benefits

• Competitive salaries • Performance-based incentives • A wide variety of benefits programs to address the diverse individual needs of employees and their families