Senior Clinical Trials Regulatory Strategist

Nicklaus Children's Health System; Kentucky; On-site; USD 110,000 - 160,000; Full time

Job summary

Nicklaus Children's Research Institute in Florida is seeking a Senior Research Regulatory Specialist to oversee a portfolio of complex clinical trials, ensuring human subjects protection, sponsor compliance, and timely regulatory submissions.

You will coordinate IRB, IBC, and COG activities, mentor junior staff, and maintain electronic regulatory binders and CTMS records across multiple sites to support start-up, maintenance, and audit readiness.

Qualifications

• Bachelor's degree or equivalent in life sciences with 4+ years in regulatory affairs.
• Experience managing regulatory submissions for complex portfolios.

Responsibilities

• Oversee full lifecycle of regulatory submissions for a complex portfolio of clinical trials.
• Provide expert guidance on IRB/IBC submissions, regulatory strategy, and compliance.
• Lead regulatory site activation and start-up activities for multi-site studies.
• Maintain electronic regulatory binders and CTMS data across locations to ensure audit readiness.
• Mentor junior regulatory staff and drive process improvements across the team.

Skills

CTMS

OnCore

eTMF Florence

REDCap

Regulatory submissions

IRB/IBC oversight

Education

Bachelor's Degree in life sciences

Tools

OnCore

Florence eTMF

REDCap

Job description

Nicklaus Children's Research Institute in Florida is seeking a Senior Research Regulatory Specialist to oversee a portfolio of complex clinical trials, ensuring human subjects protection, sponsor compliance, and timely regulatory submissions.

You will coordinate IRB, IBC, and COG activities, mentor junior staff, and maintain electronic regulatory binders and CTMS records across multiple sites to support start-up, maintenance, and audit readiness.