Regulatory Specialist Jobs

About The Position

Requirements

• Bachelor's degree or four years of clinical research experience.
• Four to seven years of clinical research regulatory affairs experience, including progressive responsibility and independent management of complex study portfolios and sponsor and cooperative group submissions.
• ACRP or CCRP certification.
• Experience supporting Phase 1 clinical trials.
• Experience with oncology clinical trials and National Clinical Trials Network trials.
• Willingness to support research operations across multiple locations.
• Proficiency with clinical trial management systems; OnCore is preferred.
• Proficiency with electronic regulatory binder systems; Florence eTMF is preferred.
• Experience using REDCap for research data management.
• Ability to work independently and collaboratively as part of an interdisciplinary team.
• Ability to exercise discretion, sound judgment, and critical thinking independently.
• Strong attention to detail and integrity in maintaining confidentiality.
• Ability to organize and prioritize a complex, dynamic workload, multitask, and meet deadlines despite interruptions.
• Advanced problem-solving ability to resolve complex regulatory concerns and improve workflow efficiency.
• Knowledge of multi-site research operations and study start-up for new research locations.
• Strong communication and consultative skills to synthesize complex regulatory information, guide stakeholders, and mentor junior staff.
• Strong computer skills, including Microsoft Outlook, Word, Excel, and PowerPoint, as well as REDCap, CTMS, and electronic regulatory systems.

Nice To Haves

• Proficiency with OnCore CTMS.
• Proficiency with Florence eTMF electronic regulatory binder system.

Responsibilities

• Independently manage regulatory submissions throughout the lifecycle of a complex clinical trial portfolio, including new study applications, amendments, continuing reviews, closures, consent documents, and reportable events.
• Prepare and submit materials on time while meeting institutional, sponsor, cooperative group, and regulatory deadlines.
• Provide advanced regulatory guidance on submission strategy, risk mitigation, study start-up readiness, and compliance requirements.
• Lead regulatory site activation and study start-up, coordinating approvals and documentation with sponsors, investigators, ancillary departments, and operational teams, including for new research locations.
• Maintain ongoing regulatory compliance and accurate electronic regulatory binders, including essential documents such as FDA 1572 forms, financial disclosures, delegation logs, CVs, and licenses.
• Monitor and implement protocol updates from the National Clinical Trials Network and other sources, submitting changes promptly to affected teams.
• Coordinate with the Clinical Trials Office, Office of Sponsored Projects, pharmacy, nursing, and other stakeholders to resolve regulatory issues, support budget alignment, report adverse events and deviations, and maintain audit readiness.
• Oversee Children's Oncology Group membership and rostering, maintaining institutional compliance, role assignments, documentation, and records.
• Participate in sponsor, NCTN, and FDA audits, including document preparation and response activities.
• Guide and mentor junior regulatory staff through training and workflow guidance, and contribute to process improvement, standardization, and quality initiatives.
• Maintain portfolio visibility and accountability through accurate CTMS data entry, regular status reporting, risk identification, and proactive management of timelines and deliverables.
• Serve as a subject matter expert on human subject clinical trial regulations and operational requirements for national group, industry-sponsored, investigator-initiated, and cooperative group studies.