Clinical Research Associate / Senior CRA

Edwards Lifesciences

. Conduct clinical monitoring activities at sites across Germany .

Posted 9/18/2026full-timeRemote • Germany, FranceSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in clinical monitoring and regulatory compliance within medical device studies, with strong communication and organizational skills to effectively manage site interactions and project milestones.

Highest-signal resume keywords

Clinical Monitoring ExperienceRegulatory ComplianceQuality AssuranceFluency in English and GermanMS Office Suite Proficiency

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Clinical Trial Site MonitoringData ReviewAdverse Event ReportingProtocol Deviation ManagementCase Report Form CollectionProcess ImprovementAudit ReadinessDevice AccountabilitySafety ReportingMedical Device Experience

Soft Skills

Excellent Communication SkillsOrganizational SkillsInterpersonal Relationship SkillsProblem-Solving SkillsCritical Thinking Skills

Certifications & Qualifications

Bachelor's Degree

Industry Keywords

Medical DeviceClinical ResearchPharmaceuticalEthics CommitteesCompetent AuthoritiesCardiology

About the role

Key responsibilities & impact

Conduct clinical monitoring activities at sites across Germany
Serve as key contact to assigned clinical sites throughout the study process
Achieve and report on agreed clinical milestones
Support study team interactions with Ethics Committees and Competent Authorities
Participate actively in project team meetings
Collaborate closely with internal stakeholders to ensure proper project conduct
Assist in providing site and Edwards personnel training
Prepare and maintain study documents and complete forms
Report site enrollment progress, device accountability, and protocol deviations
Collect completed Case Report Forms and audit supporting documentation
Process adverse events
Document procedural case observations for post-procedural event investigations
Perform data review, safety reporting, and complaint handling
Identify and report adverse events and device-related complications
Develop and implement improved processes
Ensure audit readiness for internal, external, and site audits
Perform other incidental duties assigned by management

Requirements

What you’ll need

Bachelor's Degree in a related field, and/or proven record of strong relevant experience
Previous related medical device and/or clinical experience required
Previous clinical trial site monitoring experience in Germany within a Medical Device or Pharmaceutical setting
Experience of different types of monitoring visits and in different study stages
Quality assurance and regulatory compliance in a clinical research setting
Driving licence required
Fluency in both English and local language (French or German as applicable) is essential
Excellent communication and organizational skills
Proven expertise in MS Office Suite and ability to operate general office machinery
Good written and verbal communication skills, presentation, and interpersonal relationship skills including negotiating and relationship management skills
Good problem-solving and critical thinking skills
Adhere to all company rules and requirements, including pandemic protocols and Environmental Health & Safety rules
Cardiology and/or medical device study experience desirable

Benefits

Comp & perks

Full-time employment
National travel and some travel within the wider European region
Training opportunities, including site and Edwards personnel training