Clinical Research Monitoring Specialist

Edwards Lifesciences

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

Posted 9/22/2026full-timeRemote • California • United StatesMid-LevelSenior💰 $87,000 - $123,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial monitoring, regulatory compliance, and data quality assurance, with a strong focus on GCP and medical device regulations. Proficient in training and communication, ensuring adherence to protocols and effective collaboration with clinical personnel.

Highest-signal resume keywords

Clinical Trial MonitoringRegulatory ComplianceGCP TrainingData Quality AssuranceTechnical Writing

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Field MonitoringQuality AssuranceRegulatory DocumentationData ValidationTechnical WritingClinical Research CertificationCardiovascular Anatomy KnowledgeAdverse Event ReportingCRF DevelopmentProcess Improvement

Soft Skills

Strong Communication SkillsInterpersonal SkillsAnalytical SkillsProblem-Solving SkillsCritical Thinking Skills

Tools & Technologies

MS Office SuiteAdobeGeneral Computer Software

Certifications & Qualifications

ACRP CertificationSoCRA Certification

Industry Keywords

Clinical TrialsGCPRegulatory RequirementsDevice AccountabilityEthics CommitteesResearch Ethics 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
Determine whether clinical trial/study subject documentation aligns with the study hypothesis
Monitor clinical trial/study safety in accordance with protocols, GCP, and regulatory requirements
Provide oversight and insights into trial activities, including protocol compliance, enrollment, monitoring deviations, and data quality
Report findings to principal investigators, support staff, sponsor management, leadership, Institutional Review Boards/Ethics Committees, Research Ethics Committees, and Clinical Operations
Recommend and develop process improvements
Verify trial/study data and maintain appropriate internal and external regulatory documents
Audit sites for appropriate regulatory documentation and proper source documentation
Validate investigational device accountability from Edwards through field sites and final disposition
Develop and deliver training on GCPs, protocols, databases, compliance, device accountability, adverse event reporting, investigation protocols, amendments, and regulatory documentation
Train and proctor new employees on trial- and study-related activities

Requirements

What you’ll need

Bachelor's Degree or equivalent in related field
3 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
Strong written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills
Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery
Demonstrated problem-solving and critical thinking skills
Strong understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise
Substantial 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

Benefits

Comp & perks

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