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← Iterative Health

Senior Clinical Regulatory Specialist

Iterative Health
Location
NYC, Cambridge or Southlake HQ
Posted
1 month ago
Department
Site Operations
What they actually want (must-haves)
  • 4+ years of relevant experience in clinical research, clinical regulatory, and/or research operations supporting industry-sponsored clinical trials
  • Strong experience supporting Phase 2–4 sponsor-initiated clinical trials, ideally in a site-facing regulatory capacity
  • Previous experience as a Clinical Research Coordinator (CRC), Regulatory Coordinator/Specialist, or in another clinical research role with significant responsibility for regulatory activities
  • Strong working knowledge of Good Clinical Practice (GCP), applicable FDA regulations and guidance, IRB processes, and clinical research SOPs
  • Demonstrated experience independently managing regulatory activities across multiple studies and/or research sites
  • Experience reviewing regulatory documentation and submissions for quality, completeness, and compliance
Nice to have
  • Experience mentoring, training, or providing guidance to less experienced team members
  • Experience with a Clinical Trial Management System (CTMS), electronic regulatory platform, eSource, or other clinical research technology
What the job really is

As a Senior Clinical Regulatory Specialist at Iterative Health, you will oversee regulatory activities for Phase 2–4 clinical trials, ensuring compliance throughout the study lifecycle. Your role involves collaborating with various stakeholders, managing regulatory submissions, and providing guidance to research sites. You will also drive process improvements and mentor less experienced team members, all while maintaining a focus on regulatory excellence and compliance.

Benefits
  • Hybrid work environment with in-office collaboration two days per week
  • Comprehensive medical, dental, and vision coverage, with up to 80% of premiums covered by Iterative Health
  • Mental health and wellness support through Spring Health
  • Health HSA or FSA options, and commuter FSA contributions supported by Iterative Health
  • Unlimited PTO, 12 company holidays, and a company-wide shutdown between Christmas and New Years
  • 401(k) program with a company match of up to 3% (up to $3,000 annually)
Things to weigh
  • No salary listed
  • Fast-paced environment may require strong adaptability
  • Role involves significant independent management of complex regulatory activities
Job score3.6/5
Benefits5/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency0/5

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