Oncology Research RN Specialist - Levine Cancer Institute Clinical Trials

  • Carolinas Healthcare System
  • Charlotte, NC, USA
  • Oct 11, 2017
Full time Healthcare

Job Description

Location Details:  LCI Morehead
Job Summary
Provides patient care and coordination for clinical trial patients with a focus in the areas of Gynecologic Oncology and Immunotherapy in Melanoma and Renal Cell Carcinoma.
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.

Essential Functions
  • 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.
  • Assists in maintenance of filing systems, data repositories and systems.
  • 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.
  • Completes/resolves queries from sponsors.
  • Prepares and submits information from patient�s chart and other source documents on appropriate data forms/flowsheets/databases.
  • Assists with inventory, ordering, organization and distribution of supplies related to assigned trials.
  • Maintains patient shadow charts with appropriate source documentation.
  • 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 with the coordination of required protocol-related activities such as tests and treatments using CTMS.
  • Assists 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, ClinicalTrials.gov postings, etc.
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. 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.
At Carolinas HealthCare System, our patients, communities and teammates are at the center of everything we do. Our commitment to diversity and inclusion allows us to deliver care that is superior in quality and compassion across our network of more than 900 care locations.
As a leading, innovative health system, we promote an environment where differences are valued and integrated into our workforce. Our culture of inclusion and cultural competence allows us to achieve our goals and deliver the best possible experience to patients and the communities we serve.
Posting Notes: Not Applicable
Carolinas HealthCare System is an EOE/AA Employer