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Oncology Research Consultant - Regulatory Affairs

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Charlotte, NC, United States
Job ID: 32663
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
Conducts and develops regulatory and other research compliance related activities and documentation for investigator-initiated oncology 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 Coordinator, and: 
•    Assists Principal Investigator and team in evaluating regulatory feasibility of research studies.
•    Develops regulatory study budget in collaboration with team. 
•    Works closely with management and stakeholders in all aspects of regulatory oversight for investigator-initiated oncology research from start-up through study closeout, and protocols in development.
•    Coordinates documentation for regulatory requirements.
•    Coordinates trial-related regulatory activity to ensure the safety and well-being of patients on protocols.
•    Serves as the key regulatory resource for Principal Investigator, physicians and research team and acts as the primary regulatory liaison to facilitate study initiation, execution and termination.
•    Ensures accurate and timely regulatory data collection, submission, and query resolution.
•    Coordinates protocol and site-level documentation/activities to ensure regulatory and institutional compliance.
•    Seeks ways to reduce costs and improve efficiencies.
•    Collaborates with management and investigators through attendance at Section meetings, conferences, and other meetings.
•    Participates in protocol QA activities, monitoring visits, and audits. 
•    Participates in or coordinates special projects to improve regulatory organizational performance
•    Trains staff in preparation and conduct of investigator-initiated clinical trials.

 

Physical Requirements
Primarily works in a 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 3 years of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or Master's Degree and 2 years of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or a minimum of 6 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. Supervisory experience or experience leading teams preferred.