Senior Specialist, Clinical Research Monitoring

Edwards Lifesciences

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

Posted 10/26/2026full-timeRemote • 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 strong capabilities in technical writing and training. Proficient in assessing data consistency and ensuring adherence to GCP and regulatory standards.

Highest-signal resume keywords

Clinical Trial MonitoringRegulatory ComplianceGCP Training DevelopmentData ValidationClinical Research Certification

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Field MonitoringQuality AssuranceTechnical WritingData Documentation AssessmentAdverse Event ReportingProtocol ComplianceDevice AccountabilityClinical Protocol DevelopmentInformed Consent Form EditingMS Office Suite

Soft Skills

Excellent Communication SkillsInterpersonal SkillsAnalytical SkillsProblem-Solving SkillsCritical Thinking Skills

Tools & Technologies

AdobeGeneral Computer SoftwareOffice Machinery

Certifications & Qualifications

Clinical Research CertificationACRP CertificationSoCRA Certification

Industry Keywords

GCPRegulatory RequirementsCardiovascular AnatomyPathologyPhysiologyClinical TrialsStudy ProtocolsCase Report FormsDevice AccountabilityEnrollment Monitoring

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 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

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)
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

Comp & perks

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