Senior Specialist, Clinical Research Monitoring

Edwards Lifesciences • USA-California-Remote, MA

16d • $108,000 - $153,000

About The Position

The Senior Specialist, Clinical Research Monitoring is part of the Clinical Affairs team supporting the Transcatheter Heart Valve (THV) business unit. The role conducts field monitoring and data collection for clinical trials, reviewing trial documentation and monitoring study safety in accordance with protocols, Good Clinical Practices (GCP), and regulatory requirements. The specialist provides oversight and insights into trial activities, supports study teams and investigators, contributes to clinical study materials, and ensures investigational device accountability and appropriate regulatory and source documentation.

The role also develops and delivers technical training, mentors and proctors new or junior employees, and contributes to process improvements. Domestic travel of up to 75% is required.

Requirements

• Bachelor's degree or equivalent in a related field, with five years of field monitoring, quality assurance/control, and regulatory compliance experience; equivalent work experience based on Edwards criteria is also accepted.
• Ability to travel domestically up to 75%.

Nice To Haves

• Clinical research certification, such as ACRP or SoCRA clinical coordinator or CRA certification.
• Excellent written and verbal communication, presentation, interpersonal, and analytical skills.
• Demonstrated problem-solving and critical-thinking skills.
• Proven expertise in MS Office Suite, including Word and Excel, Adobe, and the ability to operate general computer software and office machinery.
• Excellent understanding of cardiovascular anatomy, pathology, and physiology, or the relevant business unit area of expertise.
• Moderate understanding of medical device regulatory requirements and documents, device accountability, and adverse event reporting.
• Technical writing skills, including protocols, CRF development, and study tools.
• Ability to communicate and relate well with key opinion leaders and clinical personnel.
• Experience training new hires.

Responsibilities

• Conduct field monitoring and data collection for clinical trials.
• Assess data documentation, reports, records, transcripts, and examination results for consistency with case report forms and study parameters.
• Monitor clinical trial and study safety in accordance with protocols, GCP, and regulatory requirements.
• Develop and deliver technical training on GCP, protocols, databases, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, and regulatory documentation requirements.
• Train and proctor new employees on trial- and study-related activities, and mentor new or junior-level employees.
• Provide oversight and insights into trial activities, including protocol compliance, enrollment, monitoring deviations, and data quality, to investigators, support staff, sponsor management, and leadership.
• Develop process improvements based on trial oversight and insights.
• Contribute to the development of clinical protocols, informed consent forms, and case report forms.
• Track investigational devices from Edwards to field sites through final disposition to validate device accountability.
• Verify trial data and maintain appropriate internal and external regulatory documents.
• Audit sites to confirm they have appropriate regulatory documentation and that source documentation is properly recorded.
• Edit and amend informed consent documents.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior