Oncology Research Specialist Registered Nurse

6 hours ago

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

Atrium Health is seeking a highly skilled Oncology Research Specialist Registered Nurse 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.
  • Support the clinical trial team to efficiently complete tasks including documentation/submissions, Serious Adverse Events (SAEs)/safety reports, FDA Form 1572, DARFs, postings, etc.
Physical Requirements

This role primarily works in an office setting and 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.

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