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Oncology Research Coordinator - Regulatory Affairs - Levine Cancer Institute Clinical Trials

Date Posted: Apr 7, 2021
Charlotte, NC, United States
Job ID: 4762
Job Family: Research Services
Status: Full Time
Shift: Day
Shift Details: Regular
Department Name: 11011036640304-Clinical Trials - LCI
Location: LCI - 1021 Morehead Medical Dr

Overview

Job Summary
Coordinates the clinical, regulatory, business, and other research- related activities and documentation for clinical trials conducted at Levine Cancer Institute; follows industry standards and applicable regulations including FDA/OHRP guidance, GCP and ICH.

This is a Remote / Home based position. Must be within the Charlotte Regional Area.


Essential Functions

  • Fulfills the job responsibilities of the Oncology Research Specialist – Regulatory Affairs, and:
  • Coordinates regulatory submissions and documentation for clinical trial start-up, consent development and amendment, protocol amendment, continuing review, closure to accrual, action letter, suspension, termination and other reportable regulatory information.
  • Liaise with Principal Investigator, Sub-Investigators, study personnel, IRB, sponsor/CRO/monitor and other internal/external customers on clinical trial regulatory operations.
  • Conducts routine NCI research base/sponsor website reviews to identify regulatory updates and actions required.
  • Coordinates accurate data collection and record keeping by reviewing documents and processes for quality assurance, compliance, and ensures timely and accurate submission of data.
  • Coordinates and prepares for internal and external audits.
  • Participates in sponsor study start-up and follow-up meetings as appropriate.
  • Collaborates and ensures procedural compliance related to study conduct.
  • Assists in the development, improvement and review of Standard Operating Procedures and processes.
  • Provides educational and technical assistance to research staff including orientation and mentoring of new research teammates.

Physical Requirements
Primarily works in remote/home based 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 1 year of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or Master's Degree and 0-1 year of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or a minimum of 3 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. Working knowledge of the research regulatory aspects is important as is the ability to work in a fast-paced environment. Prior experience with electronic systems is desired.