Miami-Based Senior Oncology Regulatory Lead – Phase 1

Nicklaus Children's Health System; Miami (FL); On-site; USD 90,000 - 120,000; Full time

Job summary

Nicklaus Children's Health System seeks a Senior Regulatory Specialist for the Cancer Center to manage regulatory submissions for complex trials across multiple sites. You will serve as the regulatory SME, guiding onboarding, strategy, and compliance for investigators and sponsors.

The role involves coordinating IRB/IBC submissions, maintaining document accuracy, and ensuring audit readiness with OnCore, Florence eTMF, and REDCap expertise.

Qualifications

• Bachelor's Degree or 4 years clinical research experience.
• 4-7 years of clinical research regulatory affairs experience.
• ACRP or CCRP certification is preferred.
• Experience with oncology trials and multi-site start-up.

Responsibilities

• Independently manages regulatory submissions for complex trials and timelines.
• Serves as regulatory SME for assigned studies and guides start-up readiness.
• Leads site activation and regulatory documentation across locations.
• Maintains electronic regulatory binders and essential regulatory documents.
• Supports audits and sponsor communications to ensure compliance.

Skills

Regulatory strategy

IRB/IBC submissions

Cross-functional collaboration

Education

Bachelor's Degree

Tools

OnCore

Florence eTMF

REDCap

Job description

Nicklaus Children's Health System seeks a Senior Regulatory Specialist for the Cancer Center to manage regulatory submissions for complex trials across multiple sites. You will serve as the regulatory SME, guiding onboarding, strategy, and compliance for investigators and sponsors.

The role involves coordinating IRB/IBC submissions, maintaining document accuracy, and ensuring audit readiness with OnCore, Florence eTMF, and REDCap expertise.