Clinical Research Associate

1 month ago

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

We are seeking a highly skilled and detail-oriented 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 and track 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, to principal investigators and study sponsor management and leadership staff.
  • 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 of experience in field monitoring, quality assurance/control, and regulatory compliance, or 1 year of experience working in an environment with hands-on clinical research experience encompassing all aspects of the clinical process, including cardiovascular device trials and cath lab, operating room, and/or intensive care unit familiarity.
  • 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, and ability to operate general computer software and office machinery.
  • 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.
Edwards Lifesciences is an Equal Opportunity/Affirmative Action employer.COVID Vaccination Requirement

Edwards Lifesciences is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement.

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