Senior Specialist, Clinical Research Monitoring

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $108k - $153k / year

⏰ Full Time

🟠 Senior

🔬 Research Analyst

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Edwards Lifesciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1958

⚕️ Healthcare Insurance

🧬 Biotechnology

Healthcare Insurance • Biotechnology • Medical Devices

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

• Field monitoring of studies and data collection for clinical trials • Assessing all data documentation, reports, records, transcripts, exam results for consistency with case report form • Monitoring clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements • Developing and delivering technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements • Acting as a mentor to new or junior level employees • Providing oversight of and insights into trial activities to principal investigators and support staff, including Institutional Review Boards/Ethics Committees • Contributing to the development of clinical protocols, informed consent forms, and case report forms • Validating investigational device accountability by tracking the history of investigational devices from Edwards to the field sites • Verifying trial/study data, including maintaining appropriate regulatory documents and auditing

🎯 Requirements

• Bachelor's Degree or equivalent in related field with 5 years of field monitoring, quality assurance/control and regulatory compliance experience • 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 (Preferred) • Demonstrated problem-solving and critical thinking skills (Preferred) • Proven expertise in MS Office Suite, including Word, Excel, Adobe, and general computer software (Preferred) • Excellent understanding of cardiovascular anatomy, pathology and physiology (Preferred) • Moderate understanding of medical device regulatory requirements and documents (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 to address diverse needs