Senior Clinical Research Regulatory Strategist

Miami Children’s Hospital; Miami (FL); On-site; USD 60,000 - 90,000; Full time

Job summary

Miami Children’s Hospital seeks a Sr. Research Regulatory Specialist to provide advanced regulatory oversight for clinical research efforts. This role involves managing complex clinical trial portfolios, ensuring compliance, and preparing regulatory submissions. The ideal candidate should possess 4-7 years of experience in regulatory affairs and have a Bachelor's Degree or equivalent clinical research experience.

The position requires strong communication skills, proficiency with clinical trial management systems, and the ability to work across multiple locations to support research operations.

Qualifications

• 4-7 years of experience in clinical research regulatory affairs.
• Experience in managing complex study portfolios and submissions.
• Ability to independently exercise discretion and sound judgment.

Responsibilities

• Manage the full lifecycle of regulatory submissions for clinical trials.
• Serve as the regulatory subject matter expert for assigned studies.
• Facilitate cross-functional coordination to resolve regulatory issues.

Skills

ACRP or CCRP certification

Experience with Phase 1 clinical trials

Ability to work independently and collaboratively

Experience with oncology clinical trials

Proficiency with CTMS, preferably OnCore

Strong attention to detail

Problem-solving capabilities

Education

Bachelor's Degree or 4 years clinical research experience

Tools

Clinical trial management systems (CTMS)

REDCap

Electronic regulatory binder systems, preferably Florence eTMF

Job description

Miami Children’s Hospital seeks a Sr. Research Regulatory Specialist to provide advanced regulatory oversight for clinical research efforts. This role involves managing complex clinical trial portfolios, ensuring compliance, and preparing regulatory submissions. The ideal candidate should possess 4-7 years of experience in regulatory affairs and have a Bachelor's Degree or equivalent clinical research experience.

The position requires strong communication skills, proficiency with clinical trial management systems, and the ability to work across multiple locations to support research operations.