Clinical Research Associate II

vor 1 Monat

Mainz, Rheinland-Pfalz, Deutschland Edwards Lifesciences Vollzeit

Job Summary

Clinical Research Associate II (CRA II) is responsible for remotely supporting field clinical research associate/site activities to ensure the overall integrity of study implementation and adherence to study protocol at assigned clinical sites.

Key Responsibilities:

  • Organizing and supervising clinical study
  • Assist and conduct Clinical Monitoring activities
  • Serve as key contact to assigned clinical sites throughout the study process
  • Is accountable for achieving and reporting on agreed clinical milestones
  • Supports study team in the interactions with Ethics Committees and Competent Authorities
  • Participates actively to project team meetings, as required
  • Closing collaboration with internal stakeholders to ensure proper project conduct
  • Assist in Providing site and Edwards personnel training including preparation/maintenance of study documents, completion of forms, understanding of examinations/assessments required
  • Reporting site enrollment progress including device accountability and protocol deviations (inclusion/exclusion criteria, sequential enrollment)
  • Collecting completed Case Report Forms (CRF) and collecting, confirming and auditing supporting documentation.

Requirements:

  • Bachelor's Degree in related field
  • 3 years experience of previous related medical device and/or clinical experience
  • Clinician experience in intra-operative procedures acquired from 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 Enhanced
  • Leave Benefits
  • Transportation Benefits
  • Employee Stock Purchase Programme
  • Employee Assistance Programme
  • Comprehensive Wellness Programme including onsite gym, yoga classes and massage, preventive health checks, healthy lifestyle webinars, educational events, charity activities and much more.

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