Sr. Research Regulatory Specialist (Full Time, Days)

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

Overview

The Senior Research Regulatory Specialist supports the clinical research efforts of Nicklaus Children's Research Institute (NCRI) by providing advanced regulatory oversight and independent management of complex clinical trial portfolios in accordance with human subject protection regulations, sponsor requirements, and internal standard operating procedures (SOPs). The role independently oversees and prepares regulatory submissions for new studies, amendments, renewals, reportable events, study closures, and other committee submissions while serving as a subject matter expert on regulatory strategy, compliance, and submission readiness.

Responsibilities

• Independently manages the full lifecycle of regulatory submissions for a complex portfolio of clinical trials, including new study applications, amendments, continuing reviews, closures, consent documents, and reportable events. Ensures timely preparation and submission while meeting all institutional, sponsor, cooperative group, and regulatory deadlines.
• Serves as the primary regulatory subject matter expert for assigned studies, providing advanced guidance on submission strategy, risk mitigation, study start-up readiness, and compliance requirements to investigators, study teams, and stakeholders.
• Leads regulatory site activation and study start-up activities, coordinating with sponsors, investigators, ancillary departments, and operational teams to secure all required approvals and documentation, including support for new research locations.
• Ensures ongoing regulatory compliance across the portfolio by maintaining accurate electronic regulatory binders, preparing and updating essential documents (e.g., FDA 1572, financial disclosures, delegation logs, CVs, licenses).
• Monitors and implements protocol updates from National Clinical Trials Network (NCTN) and other sources, submitting changes promptly to affected teams.
• Facilitates cross-functional coordination with the Clinical Trials Office (CTO), Office of Sponsored Projects, pharmacy, nursing, and other stakeholders to resolve regulatory issues, support budget alignment, report adverse events/deviations, and maintain audit readiness.
• Oversees Children’s Oncology Group (COG) membership and rostering, maintaining institutional compliance, role assignments, documentation, and records.
• Participates in sponsor, NCTN, and FDA audits, supporting document preparation and response activities to uphold the highest standards of compliance.
• Provides guidance and mentorship to junior regulatory staff, including training, workflow guidance, and contributions to process improvements, standardization, and quality initiatives.
• Maintains portfolio visibility and accountability through accurate CTMS data entry, regular status reporting, risk identification, and proactive management of timelines and deliverables.
• Serves as an SME of human subject clinical trial regulations and operational requirements, including National Group, industry-sponsored, investigator-initiated, and cooperative group studies.

Qualifications

Minimum job requirements:

• Bachelor's Degree (or) 4 years clinical research experience.
• 4-7 years of experience in clinical research regulatory affairs, including independent management of complex study portfolios, sponsor and cooperative group submissions, and progressive responsibilities.

Knowledge, Skills, and Abilities

• ACRP (Association of Clinical Research Professionals) or CCRP (Certified Clinical Research Professional) certification.
• Experience supporting Phase 1 clinical trials.
• Ability to work both independently and collaboratively as part of an interdisciplinary team.
• Experience with oncology clinical trials and working with National Clinical Trials Network (NCTN) trials.
• Willingness to support research operations across multiple locations.
• Proficiency with clinical trial management systems (CTMS), preferably OnCore.
• Proficiency with electronic regulatory binder systems, preferably Florence eTMF.
• Ability to independently exercise discretion, sound judgment, and critical thinking.
• Experience using REDCap for research data management.
• Strong attention to detail with high integrity in maintaining confidentiality.
• Ability to organize and prioritize a complex and dynamic workload, multitask, and meet deadlines despite interruptions.
• Demonstrated advanced problem‑solving capabilities to resolve complex regulatory concerns and improve workflow efficiency.
• Knowledge of multi‑site research operations and study start‑up for new research locations.
• Demonstrated high‑level communication and consultative skills to synthesize complex regulatory information, guide stakeholders, and mentor junior staff.
• Strong computer skills including Microsoft Office (Outlook, Word, Excel, PowerPoint), REDCap, CTMS, and e‑regulatory systems.

Job Status: Professional