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 investigating the treatment of IBD. 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.
Iterative Health is seeking a Senior Clinical Regulatory Specialist to join our team. The Senior Clinical Regulatory Specialist will work under the direction of the Director of Regulatory Affairs with the primary responsibility of assisting 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 sponsorsrequiring Administrative and Regulatory work. 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.
What youll be doing:
Working with clinical site staff on essential document preparation, organization, data entry and Regulatory compliance maintenance
Facilitating successful study start-up, including clinical site and sponsor communication and status reporting
IRB submissions on behalf of sites
Participating in internal and external audits
What were looking for:
Expertise in clinical research, regulatory & compliance and Phase 2-4 sponsored clinical research, with a deep understanding of the site Study Coordinator role
Previous experience as a clinical research coordinator is valuable
Skilled at adhering to Good Clinical Practices (GCP), FDA essential documents guidelines, and Standard Operating Procedures (SOPs)
Experience with project management and/or functional team leadership, with strong organizational, decision-making, time management, multi-tasking and prioritization skills
Expertise in Adobe, Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams), and clinical trial management system (CTMS)
Confidence and experience presenting to various internal and external stakeholders
Some of our benefits include:
Vision/Dental/ Medical Insurance
Life/Disability Insurance
Parental Leave
Stock Options
Flexible Work Hours
Unlimited Paid Time Off
At Iterative Health, were 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.

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