Clinical Regulatory Specialist

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across the US and Europe, accelerating the path to market for gastrointestinal and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech‑enabled services, combining deep expertise in clinical trials with cutting‑edge AI to expand and expedite access to novel therapeutics. Clinical Regulatory Specialist Cambridge, Massachusetts, United States; New York, New York, United States Iterative Health is seeking a Clinical Regulatory Specialist to join our team. The Clinical Regulatory Specialist will work under the direction of a Clinical Regulatory Manager or Director with the primary responsibility of assisting research sites with the conduct and compliance of Phase 2–4 pharma‑sponsored research studies. This position will be a collaborative individual contributor, working with internal stakeholders, clinical sites, and study sponsors/CROs – requiring results‑driven administrative and regulatory work. What you’ll be doing: Working alongside research sites on essential regulatory document completion, ISF filing, and study correspondence Facilitating clinical trial regulatory activity from study start‑up through closeout IRB submissions on behalf of sites Participating in monitor visits and site‑level audits May serve as a primary point of contact for clinical site staff What we’re looking for: Experience in clinical research, regulatory, and compliance in Phase 2–4 sponsor‑initiated clinical trials Familiarity with good clinical practices (GCP), FDA guidelines, and standard operating procedures (SOPs) Strong organizational, decision‑making, time‑management, multi‑tasking, and prioritization skills Ability to communicate effectively both internally and with external customers Previous experience using a clinical trial management system (CTMS) is preferred Requirements: 2+ years of relevant work experience Previous experience as a clinical research coordinator or a site‑facing clinical regulatory dedicated research role 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 View email address on click.appcast.io. #J-18808-Ljbffr