Clinical Research Associate at Edwards Lifesciences

Setup: Remote - Germany, Hybrid
Type: Full-time
Level: Entry-level

Description

Edwards Lifesciences is seeking an experienced Clinical Research Associate or Senior CRA to monitor clinical sites in Germany, focusing on medical device trials in Cardiology. The role involves conducting monitoring activities, ensuring study integrity, communicating with ethics committees, assisting with training, managing CRFs, processing adverse events, and preparing for audits. Travel within Germany and occasionally internationally is required.

Required Skills

Clinical Monitoring
Regulatory Compliance
Data Review
Safety Reporting
Adverse Event Identification
Audit Readiness
Microsoft Office Suite
Communication Skills
Organizational Skills
Problem-Solving Skills
Critical Thinking Skills

Additional Information

Minimum Education: Bachelor's Degree in a related field
Required Previous Experiences: 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
Preferred Qualifications: 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
Cardiology and/or medical device study experience desirable.