Oncology Research Specialist - RN LCI
Company: Atrium Health
Posted on: January 26, 2023
Assists with the coordination of 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.
* Assists with clinical, regulatory, business, and other
documentation associated with oncology research projects/clinical
trials within LCI.
* Participates in the study project start-up activity, working with
the PI and others to initiate new research projects.
* Maintains protocol amendments, deviations, and informed consent
changes regarding oncology research studies, assuring all
documentation is managed compliantly and maintained in an
* Maintains appropriate documentation, (i.e. FDA Form 1572, CTSU
documentation, IRB approval letters, ICFs, etc.) for assigned
* Assists in maintenance of filing systems, data repositories and
* Assists in the monitoring of clinical trial compliance by
reporting issues and problems appropriately.
* Obtains required documentation (forms, slides, reports, etc.) to
assess patient eligibility for research studies.
* Contacts local research staff to confirm scheduling of
tests/treatments required by protocol.
* Obtains and completes data for patients enrolled on clinical
* Completes Case Report Forms (CRFs) maintaining high level of
* Completes/resolves queries from sponsors.
* Obtains required forms, slides, reports, and other information
needed to assess patient eligibility.
* Prepares and submits information from patient's chart and other
source documents on appropriate data
* Assists with inventory, ordering, organization and distribution
of supplies related to assigned trials.
* Maintains supply inventory with critical focus on expiry
* Maintains regulatory binder for review at monitoring visits.
* Maintains patient shadow charts with appropriate source
* Completes registration for patient enrollment and maintains
status in sponsor and LCI databases.
* Assists with the coordination of research monitor visits and
audits; prepares appropriate data.
* Assists in the collection, preparation and shipping of
* Assists with the coordination of required protocol-related
activities such as tests and treatments using CTMS.
* Assists in writing/updating Informed Consents with PI and
* Supports the clinical trial team to efficiently complete tasks
including documentation/submissions, Serious Adverse Events
(SAEs)/safety reports, FDA Form 1572, DARFs, ClinicalTrials.gov
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
Education, Experience and Certifications
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.
Keywords: Atrium Health, Charlotte , Oncology Research Specialist - RN LCI, Healthcare , Charlotte, North Carolina
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