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 Clinical Regulatory Manager 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 sponsors–requiring results-driven 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 you'll be doing:

• Working with clinical site staff on essential regulatory document preparation, organization, data entry, and ensuring regulatory compliance
• Facilitating clinical trials successful from study start-up through closeout
• IRB submissions on behalf of research sites
• Participating in internal and external audits
• Serving as a point of contact for clinical site staff and key external stakeholders
• Assisting in managing site, vendor, and sponsor relationships
  
  

Required skills:

• Expertise in sponsor-initiated clinical research, regulatory compliance, and Phase 2-4 clinical research with an understanding of the site Study Coordinator role
• Skilled at adhering to Good Clinical Practice (GCP), FDA guidelines, and Standard Operating Procedures (SOPs)
• Skilled at project management with strong organizational, decision-making, time management, multi-tasking and prioritization
• 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, Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams), and Google Workspace
  
  

Preferred skills:

• Previous experience as a clinical research coordinator, regulatory associate, and/or start-up specialist is valuable
• Experience working with a clinical trial management system (CTMS)
  
  

Applicant note: Iterative Health is running a 3 month return to office pilot for any employee within a 45 minute commute of our Cambridge, MA; Dallas, TX; or New York City offices. If you are hired for a role, and live within a 45 minute commute of one of those office locations, you will be asked to report to the office twice per week. Exceptions to this pilot will be made as necessary.

If you'd like to understand whether you're within a 45 minute commute of one of our offices, please email recruiting@iterative.health to get an address for the office location.

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, 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.