Sr. Regulatory Specialist
About The Position
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 cardiology, with the aim of helping to optimize clinical trials. 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 the Chief of Staff 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.
Requirements
- 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
- 2+ years of relevant work experience
- Previous experience as a clinical research coordinator or a site facing clinical regulatory dedicated research role
Nice To Haves
- Previous experience using a clinical trial management system (CTMS) is preferred
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
