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Oncology Research Specialist - Regulatory Affairs

This job posting is no longer active.

Charlotte, NC, United States
Job ID: 53623
Job Family: Research Services
Status: Full Time
Shift Details: Regular
Department Name: 11011036640304-Clinical Trials - LCI
Location: LCI - 1021 Morehead Medical Dr

Overview

Job Summary:

Coordinates regulatory and research compliance related activities and documentation for oncology research in adherence to industry standards and applicable regulations including FDA/OHRP guidance, GCP/ICH, IRB, and institutional policies.

 

Additional Essential Functions:

  • Assists with regulatory and other compliance documentation associated with oncology research projects/clinical trials.
  • Compiles, prepares, reviews, and submits protocol submissions from study start-up through study termination, including amendments, safety reports, renewals, etc.
  • Participates in the research study start-up activity, working with the PI and others to initiate new research projects within activation timelines.
  • Maintains and assures all assigned study regulatory obligations are managed compliantly in accordance to standard procedures.
  • Maintains documentation for assigned studies in an audit-ready manner and assists in the preparation of site audits and FDA inspections.
  • Serves as study liaison to the IRB.
  • Assists in timely filing of documents and maintains electronic data repositories and other electronic systems.
  • Assists with the development of and maintains process guidelines to ensure procedural compliance
  • Assists in the monitoring of clinical trial compliance by reporting issues and problems appropriately.
  • Communicates with research team, sponsors, and IRB on the status of assigned studies.

 

Physical Requirements
Primarily works in a remote/home-based 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.