Independent Contract CRA - East Coast
Cyberonics - Raleigh, NC

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The Clinical Research Associate (Contract) is responsible for management and oversight of company-sponsored domestic and international clinical trials. The position will require frequent travel to clinical sites covering the East Coast area. Key Responsibilities:
  • Monitor (pre-study, initiation, routine, and close-out visits) investigator sites for Good Clinical Practice (GCP) compliance according to Company SOPs and relevant FDA, and international, regulations.
  • Recruit investigators to participate in Company-sponsored studies.
  • Obtain, review, and process regulatory and administrative documents from investigator sites.
  • Prepare and/or review Serious Adverse Event (SAE) reports.
  • Author monitoring trip reports.
  • Review and verify completed CRFs.
  • In conjunction with the Biostatistics Department, periodically review the completeness of all entered or monitored data.
  • Evaluate data and/or monitoring reports for protocol violations and serious protocol deviations, and proactively address violations/deviations.
  • Resolve queries of CRF data with study site personnel.
  • Train and mentor CRAs on monitoring, internal procedures, and query resolution.
  • Perform other duties as may be assigned by management.
  • Interact with statisticians in analysis of clinical data.
TRAVEL REQUIREMENTS - High Travel requirements: This position may require extensive domestic and international business travel of 50% or more of the time.

Minimum Requirements and Qualifications:
  • Bachelor’s Degree in a physical science or RN.
  • Ability and willingness to travel up to 50% of the time, as needed.
  • 2+ years’ experience in monitoring or in-house management of clinical trials.
  • Excellent organizational skills.
  • Excellent written and oral communication skills.
  • MS Office proficient.
  • Familiarity with commercial data-management or EDC systems.
Desired Requirements and Qualifications:
  • Prior experience overseeing a Class III device or pharmaceutical clinical trial from inception of study to completion.
  • Working knowledge of Investigational Device Exemption (IDE) regulations.
  • Prior experience drafting Informed Consent documents
  • Working knowledge of Good Clinical Practices (GCPs)

About this company
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Cyberonics is a sharply innovative and progressive medical device company whose commitment to our mission is unsurpassed! Our products and...