Clinical Regulatory Specialist

As a Clinical Regulatory Specialist at Iterative Health you will play an important role in supporting the compliant and efficient execution of Phase 24 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 lifecyclefrom 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 Youll 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 24 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 24 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 $3000 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!