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Coordinator - Oncology Research - RN

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Date Posted: Apr 21, 2021
Charlotte, NC, United States
Job ID: 5073
Job Family: Nursing
Status: Full Time
Shift: Day
Shift Details: Regular
Department Name: 11011036640302-Clinical Trials - LCI Pediatric Oncology
Location: LCI - 1021 Morehead Medical Dr

Overview

Job Summary

Coordinates the clinical, regulatory, business, and other research- related activities and documentation for clinical trials conducted by the Levine Cancer Institute, following industry standards and applicable regulations including FDA/OHRP guidances, GCP and ICH.



Essential Functions

  • Competently fulfills the job responsibilities of the Oncology Research Specialist, and:
  • Coordinates clinical and regulatory document submissions for clinical trial start-up, consent development and amendment, protocol amendment, continuing review, closure to accrual, action letter, suspension, termination and other reportable regulatory information.
  • Assesses patient eligibility through chart reviews and patient/family interviews.
  • Assists in providing patient education regarding the nature of their disease and the benefits/risks of participating in a clinical drug trial.
  • Collaborates with regulatory team, Principal Investigator, Sub-Investigators, study personnel, IRB, sponsor/CRO/monitor and other internal/external customers to efficiently coordinate documentation/submissions. Conducts routine NCI research base/sponsor website reviews to identify regulatory updates and actions required.
  • Presents and obtains patient informed consent.
  • Coordinates accurate data collection and record keeping by reviewing documents and processes for quality assurance.
  • Ensures timely and accurate submission of data.
  • Coordinates and prepares for internal and external audits.
  • Participates in sponsor study start-up and follow-up meetings as appropriate.
  • Develops study calendars.
  • Collaborates on billing and financial activity with Research Finance (budgets and billing compliance).
  • Coordinates scheduling of patient visits, labs, and diagnostic procedures across LCI locations.
  • Coordinates drug shipments, storage, and accountability with IDS/Pharmacy.
  • Assists in the development, improvement and review of Standard Operating Procedures and processes.
  • Provides educational and technical assistance to research staff including orientation and mentoring of new research staff.
  • Collaborates and participates with teams across the LCI enterprise in a professional and courteous manner.
  • Interacts professionally with patients and families.

Physical Requirements

Primarily works in an office setting. Requires full range of body motion; sitting for extensive periods of time; walking, standing, reading, and writing/keyboarding. Occasionally lifts and carries items weighing up to 35 pounds. Requires corrected vision and hearing within normal range. Must speak and read/write clearly in English. Must be able to be mobile within the entire healthcare system and other locations that participate in LCI clinical trials.



Education, Experience and Certifications

Must hold a valid North Carolina or South Carolina (as applicable) Board of Nursing license. Bachelor’s Degree (BS) and 1 year of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or Master’s Degree (MS) and 0-1 year of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or a minimum of 3 years clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required with no degree. Bachelor’s Degree in Nursing (BSN) or Master’s Degree in Nursing (MSN) or other health/science degree concentration preferred. CPR certification required. Previous experience in a healthcare setting preferred, especially cancer care and/or clinical research. Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred.