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 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. Clinical Regulatory Specialist Cambridge, Massachusetts, United States, New York, New York, United States 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 US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. Iterative Health is pioneering the use of artificial intelligence-based precision medicine in gastroenterology, with the aim of helping to optimize clinical trials. We use advanced machine learning and computer vision to interpret endoscopic videos along with other types of data, helping clinicians better assess patients with potential GI problems. Ultimately, the company aims to establish more meaningful endpoints to serve as better predictors of both therapeutic response and disease outcomes. This is an exciting time in the Clinical Research industry! Our team is driving the advancement of research by implementing streamlined processes, with a mission of getting treatment options to patients in a faster, more efficient way. 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 Familiar with adhering to 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 CandidateAccommodations@iterative.health.