Sr. Research Regulatory Specialist (Full Time, Days)

Job Summary

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).

Job Specific Duties

• 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.
• 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.
• Led 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).
• Maintains portfolio visibility and accountability through accurate CTMS data entry, regular status reporting, risk identification, and proactive management of timelines and deliverables.

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, and sponsor and cooperative group submissions and has taken on 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.