Research Monitor

2 days ago


Columbus, Ohio, United States Edwards Lifesciences Full time
Job Summary

We are seeking a highly skilled Associate Clinical Research Monitor to join our team at Edwards Lifesciences. As a key member of our Clinical Affairs team, you will play a critical role in ensuring the safety and integrity of our clinical trials.

Key Responsibilities
  • Conduct field monitoring of studies and data collection for clinical trials, ensuring accuracy and consistency in data documentation and reports.
  • Verify trial/study data, including maintaining regulatory documents and auditing site compliance with study protocols and Good Clinical Practices (GCP).
  • Validate investigational device accountability by tracking device history from Edwards to field sites and final disposition.
  • Provide oversight and insights into trial activities, including protocol compliance, enrollment, monitoring deviations, and data quality.
  • Develop and deliver training on GCPs, protocols, and database compliance, device accountability, and adverse event reporting.
  • Edit and amend informed consent documents.
Requirements
  • Bachelor's Degree or equivalent in a related field.
  • 1 year experience in field monitoring, quality assurance/control, and regulatory compliance, or equivalent experience in a clinical research environment.
  • Ability to travel up to 75% for clinical site visits.
  • Covid Vaccination.
Preferred Qualifications
  • Substantial computer literacy in MS Office, including Word, Excel, and Adobe.
  • Understanding of cardiovascular anatomy, pathology, and physiology.
  • Understanding of medical device regulatory requirements and documents, device accountability, and adverse events reporting.
  • Technical writing skills (protocols, CRF development, study tools).
  • Ability to communicate and relate well with key opinion leaders and clinical personnel.
  • Experience with electronic data capture.
Company Overview

Edwards Lifesciences is a global leader in the development, manufacturing, and marketing of innovative medical solutions for the treatment of cardiovascular disease. We are committed to protecting our vulnerable patients and the healthcare providers who are treating them.


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