Cell & Gene Therapy Regulatory Coordinator

Columbia University Irving Medical Center; New York (NY); On-site; USD 68,000 - 75,000; Full time

Job summary

Columbia University Irving Medical Center is hiring a Cell and Gene Therapy Regulatory Coordinator. This full-time position involves ensuring regulatory compliance for advanced therapy trial submissions and facilitating patient access to innovative treatments.

The candidate will coordinate protocol submissions, maintain audit-ready files, and support research teams in navigating regulatory requirements. An educational background and strong organization skills are essential.

Qualifications

• Bachelor's degree or equivalent in education and experience.
• HIPAA, Good Clinical Practice (GCP), and Conflict of Interest (COI) training certification required upon hire.
• Excellent organizational, analytical, and problem-solving skills.

Responsibilities

• Coordinates all aspects of advanced therapy protocol submission for research projects.
• Ensures regulatory approvals for all required components of trials are obtained.
• Coordinates assigned study monitoring and auditing visits for protocols.

Skills

Organizational skills

Analytical skills

Problem-solving skills

Interpersonal skills

Proficiency with Microsoft Office

Education

Bachelor's degree or equivalent

Tools

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Microsoft Teams

Microsoft OneDrive

Microsoft SharePoint

Smartsheet

Job description

Columbia University Irving Medical Center is hiring a Cell and Gene Therapy Regulatory Coordinator. This full-time position involves ensuring regulatory compliance for advanced therapy trial submissions and facilitating patient access to innovative treatments.

The candidate will coordinate protocol submissions, maintain audit-ready files, and support research teams in navigating regulatory requirements. An educational background and strong organization skills are essential.