Oncology Research Specialist – LCI Regulatory Affairs

Overview

Position Description

Job Summary

Coordinates regulatory, research compliance related activities and documentation for oncology research in adherence to industry standards and applicable regulations including FDA/OHRP guidance, GCP/ICH, IRB, and institutional policies.

Essential Functions

• Assists with regulatory and other compliance documentation associated with oncology research projects/clinical trials within LCI.
• Participates in the study project start-up activity, works with the PI and others to initiate new research projects within activation timelines.
• Maintains protocol amendments, deviations, and informed consent changes regarding oncology research studies, assures all documentation is managed compliantly and maintained in an audit-ready manner.
• Assists in the monitoring of clinical trial compliance by reporting issues and problems appropriately.
• Obtains required documentation and to assess patient eligibility for research studies. ​
• Contacts local research staff to confirm scheduling of tests/treatments required by protocol. 
• Obtains and completes data for patients enrolled on clinical trials.

Additional Essential Functions

• Compiles, prepares, reviews, and submits protocol submissions from study start-up through study termination, including amendments, safety reports, renewals, etc.
• Maintains and assures all assigned study regulatory obligations are managed compliantly in accordance to standard procedures.
• Maintains documentation for assigned studies in an audit-ready manner and assists in the preparation of site audits and FDA inspections.
• Serves as study liaison to the IRB.
• Assists in timely filing of documents and maintains electronic data repositories and other electronic systems.
• Assists with the development of and maintains process guidelines to ensure procedural compliance
• Communicates with research team, sponsors, and IRB on the status of assigned studies.
• Assists in writing/updating Informed Consents with PI and team. ​
• Supports the clinical trial team to efficiently complete tasks including documentation/submissions, Serious Adverse Events (SAEs)/safety reports, FDA Form 1572, DARFs, ClinicalTrials.gov postings, etc. 
• Completes required documents/submissions in a timely manner. 
• Collaborates and participates with teams across the LCI enterprise in a professional and courteous manner.

Physical Requirements
Primarily works in a remote/home based setting in the Charlotte area. 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

High School Diploma or GED required; Bachelor's Degree preferred, Health/Science preferred. Experience in a healthcare setting preferred, especially cancer care and/or clinical research. Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred.