As a Senior Clinical Regulatory Specialist at Iterative Health, you will play a key role in supporting the compliant execution of Phase 2-4 industry-sponsored clinical trials across our clinical research network. You will provide regulatory guidance and oversight throughout the study lifecycle, from start-up and site activation through maintenance and closeout.
You will partner with clinical research sites, internal teams, sponsors, CROs, IRBs, and other stakeholders to ensure regulatory requirements are completed accurately and efficiently. You will also help identify regulatory risks, resolve complex issues, and improve processes across the network.
This role is ideal for an experienced clinical research professional with strong regulatory expertise who can independently manage multiple studies, priorities, and stakeholders in a fast-paced environment.
Where You'll Drive Impact Regulatory Operations & Compliance- Facilitate and oversee regulatory activities across the study lifecycle, including study start-up, site activation, maintenance, and closeout for Phase 2-4 industry-sponsored clinical trials.
- Provide regulatory guidance and oversight to research sites across multiple studies, ensuring timely and accurate completion of regulatory requirements.
- Review and QC regulatory documentation and submissions for completeness, accuracy, consistency, and compliance, identifying gaps and driving resolution.
- Manage complex regulatory activities and submissions, including IRB applications, amendments, continuing reviews, safety reports, unexpected events, and other study-specific regulatory requirements.
- Monitor regulatory timelines, approvals, expirations, and outstanding requirements to proactively identify potential delays or compliance risks.
- Identify, assess, and escalate regulatory risks and compliance issues, partnering with sites, sponsors, CROs, and internal stakeholders to develop and implement appropriate corrective and preventive actions.
- Serve as a subject matter resource for site teams and internal stakeholders on regulatory requirements, study-specific expectations, and best practices.
- Ensure regulatory documentation and processes remain consistent, compliant, and inspection-ready across the research network.
- Maintain accurate regulatory records, trackers, and documentation within applicable clinical research and regulatory systems.
Site Support & Relationship Management- Serve as a senior regulatory point of contact for assigned research sites and act as a liaison between sites, sponsors, CROs, IRBs, and internal stakeholders.
- Provide guidance and mentorship to site teams on regulatory processes, documentation requirements, compliance expectations, and study-specific requirements.
- Partner with sites to proactively identify regulatory challenges, develop solutions, and drive timely resolution of outstanding issues.
- Build strong relationships with site teams and establish credibility as a trusted regulatory resource.
- Participate in monitor visits, QA/QC projects, site-level audits, and other quality activities, supporting inspection readiness and remediation of identified findings.
- Support sites in preparing for regulatory inspections and audits, including identifying documentation gaps and coordinating timely remediation.
Process Improvement & Regulatory Excellence- Drive continuous improvement of regulatory processes, tools, and workflows across the clinical research network.
- Identify opportunities to improve efficiency, standardization, quality, and compliance across regulatory operations.
- Develop and maintain regulatory resources, templates, trackers, SOPs, and training materials to support consistent execution across sites.
- Support training, mentorship, and knowledge sharing for Clinical Regulatory Specialists and research site teams.
- Contribute to the development and implementation of network-wide regulatory strategies, processes, and best practices.
- Partner cross-functionally to identify trends, recurring issues, and opportunities to improve the overall site and study experience.
- Support the implementation and adoption of new regulatory systems, tools, and processes as the clinical research network scales.
- Performs related duties as requested
What You Bring to the Team - 4+ years of relevant experience in clinical research, clinical regulatory, and/or research operations supporting industry-sponsored clinical trials.
- Strong 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 clinical research role with significant responsibility for regulatory activities
- Strong working knowledge of Good Clinical Practice (GCP), applicable FDA regulations and guidance, IRB processes, and clinical research SOPs.
- Demonstrated experience independently managing regulatory activities across multiple studies and/or research sites.
- Experience reviewing regulatory documentation and submissions for quality, completeness, and compliance.
- 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 build effective relationships with site staff, sponsors, CROs, IRBs, and internal stakeholders.
- Demonstrated ability to work independently, exercise sound judgment, and take ownership of complex regulatory activities.
- Experience mentoring, training, or providing guidance to less experienced team members preferred.
- 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, Southlake, TX 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!
