Senior Specialist, Clinical Research Monitoring

🔥 3 hours ago

🏄 California – Remote

🏄 California – Remote

💵 $108k - $153k / year

⏰ Full Time

🟠 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 and study hypotheses • Monitor clinical trial/study safety in accordance with protocols, GCP, and regulatory requirements • Develop and deliver technical training on GCPs, protocols, databases, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, and regulatory documentation requirements • Train and proctor new employees and mentor new or junior-level employees • Provide oversight and insights into trial activities, including protocol compliance, enrollment, monitoring deviations, and data quality • Report insights to principal investigators, support staff, sponsor management, leadership, Institutional Review Boards/Ethics Committees/Research Ethics Boards, Contract, and Training teams • Develop process improvements • Validate investigational device accountability by tracking devices from Edwards to field sites through final disposition • Verify trial/study data and maintain appropriate internal and external regulatory documents • Audit sites for appropriate regulatory documentation and properly recorded source documentation • Edit and amend informed consent documents

🎯 Requirements

• Bachelor's Degree or equivalent in related field with 5 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 • Experience in clinical trials of medical devices preferred • Excellent written and verbal communication, presentation, interpersonal, and analytical skills preferred • Demonstrated problem-solving and critical thinking skills preferred • Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery preferred • Excellent understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise preferred • Understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting preferred • Technical writing skills (protocols, CRF development, study tools) preferred • Ability to communicate and relate well with key opinion leaders and clinical personnel preferred • Experience in training new hires preferred

🏖️ Benefits

• Competitive salaries • Performance-based incentives • Wide variety of benefits programs for employees and their families

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