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Coordinator - Oncology Research - Levine Cancer Institute

This job posting is no longer active.

Charlotte, NC, United States
Job ID: 67398
Job Family: Research Services
Status: Full Time
Shift: Day
Detailed Shift and Schedule: 8am-5pm
Remote Opportunity: Yes
Job Type: Regular
Department Name: 11011036640304-Clinical Trials - LCI

Overview

Job Summary

Coordinates the 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

  • Fulfills the job responsibilities of the Oncology Research Specialist, and:
  • Coordinates clinical and regulatory document submissions 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.
  • Assesses patient eligibility through chart reviews and patient/family interviews.
  • Assists in providing patient education regarding the nature of their disease and the benefits/risks of participating in a clinical drug trial.
  • Collaborates with regulatory team, Principal Investigator, Sub-Investigators, study personnel, IRB, sponsor/CRO/monitor and other internal/external customers; coordinates documentation/submissions. Conducts routine NCI research base/sponsor website reviews to identify regulatory updates and actions required.
  • Presents and obtains patient informed consent.
  • Coordinates accurate data collection and record keeping by reviewing documents and processes for quality assurance 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.
  • Develops study calendars.
  • Collaborates on billing and financial activity with Research Finance (budgets and billing compliance).
  • Coordinates scheduling of patient visits, labs, and diagnostic procedures.
  • Coordinates drug shipments, storage, and accountability with IDS/Pharmacy.
  • 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.
  • Provides regulatory submissions and manages regulatory documentation for clinical trial start-up, consent and/or protocol amendments, continuing review, closure to accrual, safety reporting, suspension, study termination and other information to reporting agencies and trial sponsors.
  • Liaise with Principal Investigator, Sub-Investigators, study personnel, IRB, sponsor/CRO and other internal/external entities on clinical trial regulatory operations.
  • Conducts routine NCI research base/sponsor website reviews to identify regulatory updates and actions required.
  • Oversees timely regulatory submissions to meet project deadlines.
  • Coordinates and prepares for audits with appropriate departments to address regulatory-related quality and compliance matters.
  • 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 guidelines to ensure procedural compliance.
  • Provides regulatory-related educational and technical assistance to research staff including orientation and mentoring of new research teammates.
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.

  • Primarily works in remote/home based setting in the Charlotte regional area.
  • Must speak and read/write clearly in English.



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. Regulatory knowledge of FDA/OHRP regulations, and more complex regulatory processes preferred.