Senior Specialist, Clinical Research Monitoring

🔥 2 minutes ago

🌵 Arizona, California, +1 more states – Remote

🌵 Arizona – Remote 🏄 California – Remote 🍂 Massachusetts – 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 • Determine whether subject documentation aligns with 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, investigation protocols, amendments, and regulatory documentation • Train, proctor, and mentor new or junior employees • Provide oversight and insights into trial activities, including protocol compliance, enrollment, monitoring deviations, and data quality • Report trial insights to principal investigators, support staff, sponsor management, leadership, and ethics committees • Develop process improvements • Contribute to clinical protocols, informed consent forms, and case report forms • Validate investigational device accountability from Edwards to field sites through final disposition • Verify trial/study data and maintain internal and external regulatory documents • Audit sites for required regulatory documentation and proper 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) • Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills • Demonstrated problem-solving and critical thinking skills • Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery • Excellent understanding of cardiovascular anatomy, pathology, and physiology or Business Unit area of expertise • Moderate 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 • Experience in training new hires

🏖️ Benefits

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