Clinical Research Associate / Senior CRA

🔥 0 minutes ago

🌐 Germany, France – Remote

🇩🇪 Germany – Remote 🇫🇷 France – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Edwards Lifesciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1958

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Edwards Lifesciences is a global leader in patient-focused medical innovations. The company specializes in heart valve disease solutions, offering products and services such as transcatheter heart valves and mitral and tricuspid technologies, as well as surgical heart valve solutions. Edwards Lifesciences also focuses on critical care technologies including hemodynamic monitoring, remote monitoring, and predictive monitoring. The company conducts clinical research and is committed to improving patient lives through innovative cardiovascular disease solutions, while being a responsible corporate citizen with an emphasis on global corporate giving.

📋 Description

• 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

• 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

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