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RN Oncology Research Specialist - Levine Cancer Institute Morehead - Complex Hematology Clinic Trials

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Charlotte, NC, United States
Job ID: 50966
Job Family: Nursing
Status: Full Time
Shift Details: Regular
Department Name: 11011036640304-Clinical Trials - LCI
Location: LCI - 1021 Morehead Medical Dr

Overview

The Hematology/Oncology Research RN works primarily enrolling and managing patients on clinical trials who have hematologic malignancies and non-malignant hematology disorders. We are looking for a candidate who enjoys working closely with our team of world-renowned physicians along with other members of our interdisciplinary team to offer patients a wide range of trials. These clinical trials focus across the spectrum for those undergoing initial cancer treatment, those who have recurring or advanced cancer, and those who have common or rare cancers.

The best cancer care focuses on the whole person.  Their physical and emotional needs.  That’s what makes Atrium Health Levine Cancer Institute (LCI) the region’s top-rated cancer program and the only program in the nation to be Planetree-certified for compassionate, patient-centered care.   LCI is a well-established comprehensive cancer center in Charlotte, NC. It operates within a unique model of care that provides diverse community access to world-class care, close to home. The academic hybrid model combines two important bodies of work- academic and oncology research with compassionate, community-based care.
 

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.