Clinical Research Associate

vor 4 Wochen

Kiel, Schleswig-Holstein, Deutschland Edwards Lifesciences Vollzeit
Job Summary

We are seeking a highly skilled Clinical Research Associate to join our team at Edwards Lifesciences in Germany. As a key member of our clinical research team, you will be responsible for ensuring the overall integrity of study implementation and adherence to study protocol at assigned clinical sites.

Key Responsibilities:
  • Organizing and supervising clinical studies, including assisting and conducting Clinical Monitoring activities
  • Serving as a key contact to assigned clinical sites throughout the study process
  • Being accountable for achieving and reporting on agreed clinical milestones
  • Supporting study team in interactions with Ethics Committees and Competent Authorities
  • Participating actively in project team meetings, as required
  • Closing collaboration with internal stakeholders to ensure proper project conduct
  • Assisting in providing site and Edwards personnel training, including preparation and maintenance of study documents, completion of forms, and understanding of examinations and assessments required
  • Reporting site enrollment progress, including device accountability and protocol deviations
  • Collecting completed Case Report Forms (CRF) and collecting, confirming, and auditing supporting documentation
Requirements:
  • Bachelor's Degree in a related field, with 3 years of experience in medical device and/or clinical experience
  • Clinician experience in intra-operative procedures acquired from a Registered Nursing Degree curriculum (RN), or in positions such as Radiologic Technologist (RT), Operating Room Technician (ORT), or Cardiovascular Technician (RCIS) preferred
  • Experience in interventional cardiology or cardiothoracic surgery preferred
Additional Skills:
  • Good computer skills in MS Office Suite and ability to operate general office machinery
  • Good written and verbal communication skills, presentation, and interpersonal relationship skills
  • Good problem-solving and critical thinking skills
What We Offer:
  • Competitive Compensation and Benefits package
  • Flexible working hours, remote working
  • Pension plan, Risk insurance, Meal benefits, Service awards, Leave benefits, Transportation benefits, Employee Stock Purchase Programme, Employee Assistance Programme, Comprehensive Wellness Programme

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