Regulatory Coordinator

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee regulatory operations for intricate oncology studies by preparing, submitting, and managing FDA, IRB, and institutional documentation in partnership with Principal Investigators (PIs), ORAQ, sponsors, and internal stakeholders.

• Ensure compliance and readiness for audits by maintaining thorough regulatory binders, assisting with monitoring and audit visits, addressing findings, and executing corrective actions.

• Coordinate activities related to study and site management, including site initiation, monitoring, close-out, document storage, and communication with sponsors/CROs utilizing OnCore and eREG systems.

• Apply and interpret regulatory, institutional, and federal guidelines to protocols, consent documents, SOPs, and operational plans, including support for international studies.

• Contribute to team leadership and training by mentoring colleagues, creating tools or resources, leading multidisciplinary meetings, and supporting initiatives for process improvement.

⛳️ Requirements

• Associate’s degree.

• A minimum of two (2) years of research or regulatory experience in a clinical research environment.

• Completion of the DOCR North Carolina state-approved Clinical Research Apprenticeship Program may replace one year of experience.

• Previous experience in oncology clinical trials.

• Experience in supporting complex, interventional, or investigator-initiated studies.

• Familiarity with FDA regulatory submissions and IRB processes.

• Experience collaborating with industry sponsors and/or CROs.

• Proficiency in clinical research management systems (e.g., OnCore, eREG, iRIS).

• Excellent written and verbal communication skills.

🏝️ Benefits

• Comprehensive and competitive medical and dental care programs.

• Generous retirement benefits.

• Family-friendly and cultural programs.