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Oncology Research Specialist – BCC Regulatory Affairs

Charlotte, NC, United States
Job ID: 66057
Job Family: Research Services
Status: Full Time
Shift: Day
Detailed Shift and Schedule: Weekdays 8am - 5pm
Remote Opportunity: Yes
Job Type: Regular
Department Name: 11011005032963-Beat Child Cancer Consortium - LCI

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.
  • Assists in the monitoring of clinical trial compliance by reporting issues and problems appropriately.
  • Obtains required documentation and 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 trials.

     

Physical Requirements

 

Primarily works in a remote  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.  Bachelor’s degree preferred. Two years of clinical trial experience preferred with CRO or sponsor-company. Position supports the Regulatory Consultant with all operational and trial related activities of a sponsor. Detailed knowledge of clinical trial processes, including ICH/GCP guidelines peferred. Experience in TMF set-up, maintenance, and periodic reviews preferred. Experience in review and tracking of regulatory documentation for successful implementation of clinical trials preferred.