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Registered Nurse

Unicon Pharma

Job Title: Patient Safety Associate, Transplant Programs

Location: Durham, NC, 27713

Duration: 6 months (possible extension).

Seeking a Registered Nurse to support safety monitoring for active transplant clinical trials by reviewing trial data, identifying and escalating adverse events, coordinating with vendors and clinical sites, and ensuring accurate, complete safety data.

Key Responsibilities

  • Monitor and review patient data generated from clinical trials in the Electronic Data Capture (EDC) system
  • Review Adverse Events (AEs) and Serious Adverse Events (SAEs) for completeness and accuracy
  • Liaise with the case processing vendor and safety management physician to coordinate accurate and timely assessment and regulatory compliance are maintained
  • Identify missing or discrepant data and follow up with clinical trial sites for resolution
  • Coordinate with site staff to ensure timely and accurate data flow
  • Perform quality control review of incoming patient data
  • Collaborate closely with a small, cross-functional patient safety team

Qualifications

  • Active Registered Nurse (RN) license, required
  • Bachelor of Nursing Degree
  • Minimum 7 years of experience in a critical care or bedside clinical setting
  • Experience as a transplant coordinator, or managing a hospital transplant department, preferred
  • Pharmacovigilance or drug safety experience preferred
  • Strong attention to detail with the ability to manage a high volume of clinical data
  • Effective communicator with clinical site staff and cross-functional team members
Vacancy posted more than 2 months ago

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