Clinical Regulatory Specialist

Support Regulatory Activities Across the Study Lifecycle

• Facilitate regulatory activities across the study lifecycle, including study start-up, activation, maintenance, and closeout for Phase 2–4 industry-sponsored clinical trials.
• Prepare, collect, review, and maintain essential regulatory documents to support study activation and ongoing compliance.
• Prepare and coordinate initial IRB submissions, amendments, continuing reviews, safety reports, and other required submissions on behalf of clinical research sites.
• Track regulatory submissions, approvals, expirations, and outstanding documentation to ensure requirements and study timelines are met.
• Maintain Investigator Site Files (ISFs) and other regulatory documentation, ensuring records are accurate, complete, current, and inspection-ready.

Partner With Sites & Study Stakeholders

• Serve as a regulatory partner to assigned clinical research sites, helping site teams navigate study-specific regulatory requirements and timelines.
• Serve as a primary point of contact for clinical site staff on regulatory activities, as assigned.
• Collaborate with sponsors, CROs, monitors, IRBs, and internal stakeholders to address regulatory requests, resolve documentation gaps, and support study milestones.
• Maintain clear, timely, and well-documented study correspondence with internal and external stakeholders.

Support Compliance & Inspection Readiness

• Support site compliance with study protocols, Good Clinical Practice (GCP), applicable FDA regulations and guidance, IRB requirements, and Iterative Health Standard Operating Procedures (SOPs).
• Participate in monitoring visits, audits, and other quality or compliance activities, including preparation and follow-up of regulatory documentation.
• Proactively identify missing, incomplete, or expiring documentation and partner with appropriate stakeholders to drive timely resolution.
• Identify and escalate regulatory risks, delays, or compliance concerns and support resolution and corrective actions as appropriate.
• Performs related duties as requested 

What You Bring to the Team 

• 2+ years of relevant experience in clinical research, regulatory affairs, clinical operations, or a related field supporting industry-sponsored clinical trials.
• Experience supporting Phase 2–4 sponsor-initiated clinical trials, ideally in a site-facing regulatory capacity.
• Previous experience as a Clinical Research Coordinator (CRC), Regulatory Coordinator/Specialist, or in another site-facing clinical research role with responsibility for regulatory activities.
• Working knowledge of Good Clinical Practice (GCP), applicable FDA requirements, IRB processes, and clinical research Standard Operating Procedures (SOPs).
• Experience preparing and maintaining essential regulatory documents and supporting IRB submissions throughout the study lifecycle.
• Strong organizational, time-management, and prioritization skills, with the ability to manage multiple studies, sites, deadlines, and competing priorities.
• Exceptional attention to detail and a commitment to maintaining accurate, complete, and inspection-ready documentation.
• Strong written and verbal communication skills with the ability to collaborate effectively with clinical site staff, internal teams, sponsors, CROs, and other external stakeholders.
• Sound judgment, problem-solving skills, and the ability to identify issues and escalate appropriately.
• Experience with a Clinical Trial Management System (CTMS), electronic regulatory platform, eSource, or other clinical research technology preferred.

How We Work 

• Collaborative and low-ego team environment
• High ownership and accountability culture
• Fast-paced and highly iterative growth environment
• Open communication and continuous learning mindset
• Mission-driven organization focused on improving patient outcomes
• Comfortable navigating evolving business priorities and opportunities