Coordinator - Oncology Research - Levine Cancer Institute

Overview

Job Summary

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.

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.