Clinical Regulatory Specialist

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. Clinical Regulatory Specialist Iterative Health Location: Tyler, TX (onsite) Travel expectations: Occasional (1-2 trips/year) 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 the local research site 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 the site • Participating in monitor visits and site level audits • Serve as a primary point of contact for clinical site staff and CRAs • Assist in quality control and compliance What we're looking for: • Previous experience in clinical research, regulatory, and compliance is preferred • Familiar with adhering to state and/or federal 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 Requirements: • 2+ years of relevant work experience 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.