Senior Specialist, Clinical Research Monitoring

Edwards Lifesciences

. Conduct field monitoring of studies and data collection for clinical trials .

Posted 11/9/2026full-timeRemote • California • United StatesSenior💰 $108,000 - $153,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial monitoring, regulatory compliance, and data validation, with a strong focus on GCP and device accountability. Proficient in training and mentoring staff while ensuring adherence to protocols and quality standards.

Highest-signal resume keywords

Clinical Trial MonitoringRegulatory ComplianceGCP TrainingData ValidationClinical Research Certification

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Field MonitoringQuality AssuranceData Documentation AssessmentTechnical WritingProtocol ComplianceAdverse Event ReportingDevice AccountabilityData Quality MonitoringAudit Regulatory DocumentationInformed Consent Editing

Soft Skills

Communication SkillsInterpersonal SkillsAnalytical SkillsProblem-Solving SkillsCritical Thinking Skills

Tools & Technologies

MS Office SuiteWordExcelAdobeGeneral Computer Software

Certifications & Qualifications

Clinical Research CertificationACRP CertificationSoCRA Certification

Industry Keywords

Clinical TrialsMedical DevicesRegulatory RequirementsCardiovascular AnatomyEthics Committees

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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