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Oncology Research Consultant/QA Monitor Biostats Levine Cancer Institute

Charlotte, NC, United States
Job ID: 13138
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

Conducts and develops all aspects of clinical, regulatory, business, and other research- related activities and documentation for clinical trials, following industry standards and applicable regulations including FDA/OHRP guidance, GCP and ICH.



Essential Functions

  • Participates in site selection, site initiation visits, monitoring visits (including pharmacy), close-out visits to ensure the rights and well-being of human subjects are protected.
  • Be familiar with and monitor to GCP and Code of Federal regulations requirements.
  • Ensure reported trial data are accurate, complete and verifiable from source data
  • Ensure the conduct of the trial is in compliance with the currently approved protocol, with GCP and applicable regulatory requirements
  • Fulfills the job responsibilities of the Oncology Research Consultant Monitor, including Risk Based Monitoring
  • Serves as a key resource for Sponsor-Investigator / Principal Investigator, acting as one of the primary liaisons between site and sponsor to facilitate study initiation, execution and termination.
  • Ensures accurate and timely data entry into eCRFs and query resolution.
  • Review of Site Regulatory Binder.
  • Trains staff in preparation and conduct of clinical trials
  • Assist in protocol/consent development, QA SOPs and guideline development and revision
  • Ensure that the clinical studies are conducted and documented correctly
  • Trains staff in preparation and conduct of clinical trials.

     

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

Bachelor's Degree and 3 years of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or Master's Degree and 2 years of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or a minimum of 6 years clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required with no degree. Health/Science degree preferred. Previous experience in a healthcare setting preferred, especially cancer care and/or clinical research. Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred. Supervisory experience or experience leading teams preferred. Prefer  remote monitoring experience .