Clinical Regulatory Specialist

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. As a Clinical Regulatory Specialist at Iterative Health, you will play an important role in supporting the compliant and efficient execution of Phase 2–4 industry-sponsored clinical trials across our clinical research network. Working under the direction of a Clinical Regulatory Manager Director, you will partner closely with clinical research sites to manage regulatory activities throughout the study lifecycle—from study start-up and activation through ongoing maintenance and closeout.

Responsibilities

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; 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 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

Requirements

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

Nice to have

Experience with a Clinical Trial Management System (CTMS), electronic regulatory platform, eSource, or other clinical research technology preferred.

Benefits

Hybrid work environment with in-office collaboration two days per week in either our NYC or Boston office; Comprehensive medical, dental, and vision coverage, with up to 80% of premiums covered by Iterative Health; Mental health and wellness support through Spring Health; Health HSA or FSA options, and commuter FSA contributions supported by Iterative Health; Unlimited PTO, 12 company holidays, and a company-wide shutdown between Christmas and New Years; 401(k) program with a company match of up to 3% (up to $3,000 annually); Weekly in-office lunch benefit every Tuesday; 100% company-paid short-term and long-term disability coverage; Annual wellness and professional development stipend to support your health and growth