--- title: 'Clinical Regulatory Specialist at Iterative Health' canonical: 'https://feeny.ai/job/clinical-regulatory-specialist-iterative-health-new-york-fks328pzqc8b' type: 'job' last_seen: '2026-09-11' --- # Clinical Regulatory Specialist at Iterative Health - **Company:** Iterative Health - **Location:** New York, NY / Cambridge, MA / Southlake, TX - **Posted:** 2026-08-17 - **Last confirmed live:** 2026-09-11 - **Apply:** https://job-boards.greenhouse.io/iterativehealth/jobs/4705745006 ## Job description Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology. By combining deep clinical trial expertise with cutting-edge AI, we connect sponsors' scientific ambitions with high-performing research teams that expedite and expand access to novel therapeutics for patients in need. Today, Iterative Health is headquartered in Cambridge, Massachusetts, and New York City with 250+ employees world-wide. 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. You will collaborate with site teams, internal stakeholders, sponsors, CROs, IRBs, and other external partners to ensure regulatory requirements are completed accurately, efficiently, and in accordance with applicable guidelines and study requirements. This role is ideal for someone with clinical research experience who is highly organized, detail-oriented, and comfortable managing multiple studies and priorities in a fast-paced, collaborative environment. Where You’ll Drive Impact 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 ## Benefits That Support You We believe great teams do their best work when they feel supported — professionally and personally. - 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 - And more! At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health. ## About Iterative Health ## Company Overview - **One-liner**: Iterative Health is a healthcare technology and services company that accelerates clinical research by combining AI-powered tools with a performance-driven global site network, focusing on GI, Hepatology, Obesity, and Cardiology therapies. - **Entity Type**: Private (Series C) - **Headquarters**: Cambridge, Massachusetts, United States (also New York, New York) - **Founded**: 2017 - **Founders**: Jonathan Ng, MBBS (Founder & CEO) ## Core Business - **Primary industry/industries**: Healthcare technology, clinical research services, artificial intelligence - **Target customers**: B2B – sponsors (pharma/biotech), CROs, and community-based provider networks (clinical research sites) - **Mission or purpose**: “To accelerate clinical research to bring life-changing therapies to patients sooner, transforming care through expertise and proven results.” ## Products & Services - **AI-Powered Clinical Trial Platform**: Software that streamlines site selection, patient enrollment, and operational workflows, reducing burden and accelerating trial timelines. - **Performance-Driven Site Network**: A global network of elite community-based research sites with deep expertise in GI, Hepatology, Obesity, and Cardiology, enabling faster activation and high enrollment. - **Site Enablement Services**: Operational support, training, and technology to help sites grow their research programs and improve performance. ## Market Standing - **Valuation/Market Cap**: Not publicly disclosed (private company) - **Key Metric**: Total Funding – $264 million (including $77 million Series C closed May 2026) - **Notable Investors/Partners**: Partners include GI Alliance, One GI, and US Heart & Vascular (USHV). Specific investors not named in provided materials, but Series C led by investors noted in Business Wire (May 14, 2026). - **Growth Signals**: - Raised $77M Series C in May 2026 to accelerate clinical research. - Acquired cardiology research sites from NextStage Clinical Research (April 2026), expanding into cardiology. - Presented expanded trial performance data at Digestive Disease Week 2026, demonstrating consistent outperformance of industry benchmarks at double the scale. ## Competitive Advantages - **Deep Therapeutic Focus**: Specialized expertise in GI, Hepatology, Obesity, and Cardiology allows for tailored site selection and patient recruitment that generalist CROs cannot match. - **AI Integration**: Proprietary AI tools that enhance site selection, pre-screening, and operational efficiency, reducing time-to-market for sponsors. - **Embedded Community Network**: Sites are integrated into community care settings, giving access to diverse patient populations and enabling faster, more representative enrollment. - **Performance Track Record**: Proven ability to activate sites faster and achieve industry-leading enrollment metrics, as validated by DDW 2026 data. ## Strategic Focus - **Scale the Site Network**: Continue acquiring and onboarding high-performing community sites, particularly in cardiology and other adjacent therapeutic areas. - **Deepen AI Capabilities**: Invest in machine learning and data science to further automate and optimize clinical trial operations. - **Expand Sponsor Partnerships**: Leverage the combined technology and site network to become the preferred partner for sponsors seeking rapid, reliable trial execution. ## Why Work Here - **Mission-Driven Culture**: Focus on accelerating life-changing therapies to patients; work directly impacts patient access and trial efficiency. - **Values: G.R.I.T.**: The company emphasizes collaboration, curiosity, compassion, resilience, and innovation. Described as a “people-first team of builders.” - **Benefits**: 75% paid company benefits, 401k with 3% company match, health insurance, life/STD/LTD, and paid time off plus company holidays. - **Work Environment**: Hybrid/office presence in Cambridge, MA and New York, NY. Open roles span clinical operations, engineering, data science, finance, marketing, and more. - **Growth Trajectory**: Company is well-funded (Series C, $264M total raised) and actively expanding through acquisitions and headcount, providing career advancement opportunities. ## Sources 1. [iterative.health](https://iterative.health/) – Company homepage, mission, partners, news 2. [iterative.health/about-us](https://iterative.health/about-us/) – Founding story, team, leadership 3. [iterative.health/iterative-health-careers](https://iterative.health/iterative-health-careers/) – Culture, benefits, values 4. [job-boards.greenhouse.io/iterativehealth](https://job-boards.greenhouse.io/iterativehealth) – Current job openings (35 roles) 5. [cbinsights.com](https://www.cbinsights.com/company/iterative-scopes) – Funding history, total raised, stage ## Other roles at Iterative Health - [Senior Clinical Research Coordinator](https://feeny.ai/job/senior-clinical-research-coordinator-iterative-health-flowood-r4egkaajnqg0) — Flowood, MI - [Clinical Research Coordinator I - Memphis, TN](https://feeny.ai/job/clinical-research-coordinator-i-memphis-tn-iterative-health-memphis-czn11v20anvp) — Memphis, TN - [Clinical Research Systems Specialist](https://feeny.ai/job/clinical-research-systems-specialist-iterative-health-new-york-4msj6c4vqq0e) — New York, NY / Cambridge, MA / Southlake, TX - [Research Assistant - Mansfield, TX](https://feeny.ai/job/research-assistant-mansfield-tx-iterative-health-mansfield-8t11je9smktf) — Mansfield, TX - [Clinical Research Coordinator II - Mansfield, TX](https://feeny.ai/job/clinical-research-coordinator-ii-mansfield-tx-iterative-health-mansfield-rv0h9mancmjt) — Mansfield, TX - [Research Site Manager](https://feeny.ai/job/research-site-manager-iterative-health-providence-7efmg6z2808r) — Providence, RI - [Director, Activations Strategy and Operations](https://feeny.ai/job/director-activations-strategy-and-operations-iterative-health-new-york-00wne5qx4ftf) — New York, NY / Cambridge, MA / Southlake, TX - [Clinical Research Coordinator II - Troy, MI](https://feeny.ai/job/clinical-research-coordinator-ii-troy-mi-iterative-health-troy-tve19pph0hqh) — Troy, MI - [Clinical Research Coordinator I - Webster, TX](https://feeny.ai/job/clinical-research-coordinator-i-webster-tx-iterative-health-webster-3cdvktdfajh7) — Webster, TX - [VP, US Site Management & Operations - GI](https://feeny.ai/job/vp-us-site-management-operations-gi-iterative-health-new-york-mzp6n6cw94dr) — New York, NY / Boston, MA / Dallas, TX