DescriptionJob 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). This 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.
The Senior Research Regulatory Specialist applies advanced experience supporting Phase 1 research, Independent Review Board (IRB), Institutional Biosafety Committee (IBC) submissions, and a broad range of institutional research committee reviews to guide complex study activation and ongoing regulatory maintenance. The role partners with investigators, sponsors, ancillary committees, and internal operational stakeholders to facilitate study activation, maintain audit readiness, resolve complex regulatory issues, and support continuous process improvement.
This position also applies experience using a clinical trial management system (CTMS) and electronic regulatory systems for protocol and regulatory document management, with responsibility for creating, maintaining, and scheduling portfolio reports that keep key stakeholders informed of study progress, regulatory milestones, risks, and overall portfolio status. In addition, this position supports research operations across multiple Nicklaus locations, including regulatory support for existing sites and coordination of regulatory activities required to establish and operationalize new research locations. The role also manages Children's Oncology Group (COG) membership and rostering activities, including maintenance of institutional participation requirements, roster records, role assignments, and related reporting to support ongoing network compliance and study operations.
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. 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, 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.
