Senior Clinical Regulatory Specialist

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 Senior Clinical Regulatory Specialist to join our team. The Senior 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, study correspondence, and ensuring regulatory compliance
• Facilitating clinical trial regulatory activity from study start-up through closeout for multiple studies at multiple sites
• IRB submissions on behalf of research sites (e.g. initial applications, continuing reviews, modifications, unexpected events, closeout reports)
• Participating in monitor visits, QA/QC projects, and site level audits
• Serve as a main point of contact for research site staff and a liaison between sites and Sponsors/CROs
• Assist in the development and management of site relationships

What we’re looking for:

• Expertise in clinical research, regulatory compliance, and Phase 2-4 clinical trials
• Adherence to Good Clinical Practice (GCP), FDA guidelines, and Standard Operating
• Procedures (SOPs)
• Project management capability with strong organizational, decision-making, time
• management, multi-tasking, and prioritization skills
• Requires minimal direction on generating and executing work plans
• Excellent communication skills, both written and oral, with a keen attention to detail
• Experience in Adobe Pro, Microsoft Office or Google Workspace, and clinical trial
• management systems (RealTime and/or CRIO preferred)

Requirements:  

• 5+ years of relevant work experience  
• Previous experience as a clinical research coordinator or a site facing clinical regulatory dedicated research role