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Senior Oncology Research Consultant/QA Auditor- Biostats - Levine Cancer Institute LCI II Morehead

Charlotte, NC, United States
Job ID: 6484
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

Directs and leads 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

  • Fulfills the job responsibilities of the Oncology Research Consultant, and:
  • Coordinates the clinical care of patients being evaluated for and/or patients already participating in the trial program, including research activities, and education as appropriate.
  • Directs and coordinates the management of research protocols.
  • Supervises and coordinates assigned programs across clinics/sites.
  • Collaborates with leadership in seeking ways to reduce costs and improve efficiencies.
  • Provides leadership in establishing, measuring and delivering on program goals.
  • Develops, implements, and maintains financial stewardship of research program/studies reporting to administration.
  • Develops program and protocol-specific tools to facilitate compliant work.
  • Assesses eligibility of research subjects and coaches others on eligibility assessments.
  • Tracks study enrollment and completion of milestones
  • Summarizes research findings and prepares presentations as appropriate.
  • Provides mentoring and support for new colleagues, physicians and junior staff related to clinical research.
  • Coordinates, follows, and evaluates patient participation in clinical trials to ensure compliance with the protocol.
  • Performs protocol specific tasks including patient assessment, eligibility screening, specimen collection, toxicity assessment, and monitoring of responses.
  • Provides operational and metrics information related to ongoing trials to administration
  • Serves as a resource to the Quality and Education teams to provide expertise and consultation.
  • Collaborates with principal investigator(s) to assist in developing plans for research projects and discusses the interpretation of results; collaborates on the preparation of manuscripts for publication.
  • Serves as a primary resource for teammates to address study specific questions, concerns or events, regardless of program area or location.
  • Assists with grant and protocol development, e.g. investigator initiated studies.
  • Conducts coordinating center activities and coordinates/oversees study teams.
  • Coordinates the regulatory coordination in preparing and submitting accurate study materials, interim reports, annual reports, amendments and case records to sponsors and the IRB as required within the designated time period.

     

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 clinical trials.



Education, Experience and Certifications

Bachelor's Degree and 9 years of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) required; or Master's Degree and 7 years of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) required. Health/Science degree preferred. Previous experience in a healthcare setting required, especially in a cancer care and/or cancer research environment. Certification in clinical research required. Supervisory experience or experience leading teams required.