Research Nurse Oncology Specialist

2 weeks ago

Charlotte, North Carolina, United States Atrium Health Full time
Job Summary

Atrium Health Levine Cancer Institute is seeking a highly skilled Research Nurse Oncology Research Specialist to join our team. As a key member of our clinical research team, you will be responsible for coordinating clinical, regulatory, business, and other research-related activities and documentation for clinical trials conducted by the Levine Cancer Institute.

Key Responsibilities
  • Assist with clinical, regulatory, business, and other documentation associated with oncology research projects/clinical trials within LCI.
  • Participate in the study project start-up activity, working with the PI and others to initiate new research projects.
  • Maintain protocol amendments, deviations, and informed consent changes regarding oncology research studies, assuring all documentation is managed compliantly and maintained in an audit-ready manner.
  • Maintain appropriate documentation, (i.e. FDA Form 1572, CTSU documentation, IRB approval letters, ICFs, etc.) for assigned studies.
  • Assist in maintenance of filing systems, data repositories and systems.
  • Assist in the monitoring of clinical trial compliance by reporting issues and problems appropriately.
  • Obtain required documentation (forms, slides, reports, etc.) to assess patient eligibility for research studies.
  • Contact local research staff to confirm scheduling of tests/treatments required by protocol.
  • Obtain and complete data for patients enrolled on clinical trial.
  • Complete Case Report Forms (CRFs) maintaining high level of accuracy.
  • Complete/resolve queries from sponsors.
  • Obtain required forms, slides, reports, and other information needed to assess patient eligibility.
  • Prepare and submit information from patient's chart and other source documents on appropriate data forms/flowsheets/databases.
  • Assist with inventory, ordering, organization and distribution of supplies related to assigned trials.
  • Maintain supply inventory with critical focus on expiry management.
  • Maintain regulatory binder for review at monitoring visits.
  • Maintain patient shadow charts with appropriate source documentation.
  • Complete registration for patient enrollment and maintains status in sponsor and LCI databases.
  • Assist with the coordination of research monitor visits and audits; prepares appropriate data.
  • Assist in the collection, preparation and shipping of samples.
  • Assist with the coordination of required protocol-related activities such as tests and treatments using CTMS.
  • Assist in writing/updating Informed Consents with PI and team.
  • Supports the clinical trial team to efficiently complete tasks including documentation/submissions, Serious Adverse Events (SAEs)/safety reports, FDA Form 1572, DARFs, postings, etc.
Requirements

Must hold a valid North Carolina or South Carolina (as applicable) Board of Nursing license. Graduate of an accredited nursing program (ADN, RN) required. Bachelor's Degree in Nursing (BSN), or higher, 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.

Atrium Health Levine Cancer Institute 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, patient-centered care.

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.

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