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Oncology Research Specialist- Levine Cancer Institute Biostatistics

This job posting is no longer active.

Charlotte, NC, United States
Job ID: 4451
Job Family: Research Services
Status: Full Time
Shift: Day
Shift Details: Regular
Department Name: 11011036640418-Bio Statistics - LCI
Location: LCI - 1021 Morehead Medical Dr

Overview

Job Summary

Coordinates clinical, regulatory, business, and other research- related activities and documentation for clinical trials conducted, follows industry standards and applicable regulations including FDA/OHRP guidance, GCP and ICH.



Essential Functions

  • Assists with clinical, regulatory, business, and other documentation associated with oncology research projects/clinical trials within department.
  • Participates in the study project start-up activity, works with the PI and others to initiate new research projects.
  • Maintains protocol amendments, deviations, and informed consent changes regarding oncology research studies, assures all documentation is managed compliantly and maintained in an audit-ready manner.
  • Maintains appropriate documentation for assigned studies.
  • Assists in maintenance of filing systems, data repositories and systems.
  • Perform data abstractions using electronic medical record and other sources, and enter data into observational research database.
  • Prepares and presents periodic data reviews for principle investigators and other stakeholders.
  • Assists in abstract and manuscript preparations.
  • Interact with other members of the database and statistical analysis teams for data management tasks and analysis requests..
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 clinical trials.



Education, Experience and Certifications

High School Diploma or GED required; Bachelor's Degree preferred, Health/Science preferred. Experience in a healthcare setting preferred, especially cancer care and/or clinical research. Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred.