Oncology Research Coordinator - Atrium Health Levine Cancer Regulatory Affairs & Compliance Charlotte FT

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.

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.

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.