Senior Regulatory Lead for Clinical Trials

Nicklaus Children's Health System; Miami (FL); On-site; USD 70,000 - 95,000; Full time

Job summary

Nicklaus Children's Health System is seeking a Senior Research Regulatory Specialist to support its clinical research efforts. The specialist will manage the regulatory submissions and serve as a subject matter expert on compliance and regulatory strategy.

Key responsibilities include overseeing the full lifecycle of regulatory submissions, guiding investigators, and ensuring ongoing compliance across clinical trial portfolios. A bachelor's degree or equivalent experience and relevant certification are required for this professional role.

Qualifications

• 4-7 years of experience in clinical research regulatory affairs required.
• Demonstrated high-level communication skills for guiding stakeholders.
• Ability to work independently and as part of a team.

Responsibilities

• Manage regulatory submissions for clinical trials' lifecycle.
• Serve as a subject matter expert on regulatory compliance.
• Facilitate cross-functional coordination for regulatory issues.

Skills

ACRP or CCRP certification

Experience with oncology clinical trials

Proficiency with clinical trial management systems (CTMS)

Strong attention to detail

Education

Bachelor's Degree or 4 years clinical research experience

Tools

REDCap

Microsoft Office Suite

Job description

Nicklaus Children's Health System is seeking a Senior Research Regulatory Specialist to support its clinical research efforts. The specialist will manage the regulatory submissions and serve as a subject matter expert on compliance and regulatory strategy.

Key responsibilities include overseeing the full lifecycle of regulatory submissions, guiding investigators, and ensuring ongoing compliance across clinical trial portfolios. A bachelor's degree or equivalent experience and relevant certification are required for this professional role.