About The Position

Navitas Healthcare, LLC is seeking a Clinical Research Coordinator III (RN) for a Direct Hire position in Asheville, NC. This role involves coordinating patient care for clinical research studies, ensuring adherence to Good Clinical Practice (GCP) and FDA guidelines. Responsibilities include reviewing protocols, conducting feasibility assessments, managing patient eligibility, facilitating informed consent, overseeing investigational product handling, specimen management, IRB submissions, and ensuring regulatory compliance. The role also involves supporting CAPA processes, study budget development, tracking sponsor payments, and maintaining patient confidentiality.

Requirements

  • High School Diploma required
  • Associate Degree in Nursing (ASN) or Bachelor of Science in Nursing (BSN) required
  • Active Registered Nurse (RN) license required or eligibility to obtain upon hire
  • Valid Driver’s License required
  • Minimum 2 years of nursing experience required
  • Prior clinical research experience required

Nice To Haves

  • Oncology experience preferred

Responsibilities

  • Coordinate care for patients enrolled in clinical research studies in accordance with GCP and FDA guidelines
  • Review protocol requirements and execute study procedures accurately
  • Conduct feasibility assessments and complete site qualification questionnaires
  • Assess patient eligibility using inclusion and exclusion criteria
  • Facilitate informed consent and ensure regulatory compliance throughout enrollment
  • Review diagnostic testing and protocol-required documentation
  • Monitor, document, and report adverse events and serious adverse events
  • Manage investigational product handling, including accountability, storage, and documentation
  • Oversee specimen collection, processing, and proper documentation
  • Prepare and maintain IRB/IEC submissions and regulatory binders
  • Ensure compliance with safety reporting and protocol deviation processes
  • Accurately collect and enter study data in accordance with FDA standards
  • Protect patient confidentiality, rights, and study integrity
  • Coordinate monitoring visits, audits, and follow-up requests
  • Support CAPA (Corrective and Preventive Action) processes
  • Escalate compliance or safety concerns to the Principal Investigator and leadership
  • Assist with study budget development, financial feasibility reviews, and billing compliance
  • Track sponsor payments and assist with invoicing processes

Benefits

  • Competitive pay
  • Salary discussed upfront
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