Registered Nurse Oncology Research Specialist - Atrium Health Levine Cancer Institute Clinical Trials Pineville

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.