Clinical Regulatory Specialist
Core
Support compliant and efficient execution of Phase 2–4 industry-sponsored clinical trials by managing regulatory activities across the study lifecycle.
Role type
Clinical Regulatory Specialist (via careerplan.io/jobs/4705745006-clinical-regulatory-specialist-at-iterativehealth)
Builds
Regulatory documentation, IRB submissions, and Investigator Site Files (ISFs) for clinical research sites
Domain
Clinical research / Healthcare technology
Required skills
Clinical trial experience (Phase 2–4), Regulatory affairs knowledge, IRB submission management, Investigator Site File (ISF) maintenance, GCP compliance, FDA regulations knowledge, Documentation management, Stakeholder collaboration, Time management
Preferred skills
Clinical Trial Management System (CTMS) experience, Electronic regulatory platform experience, eSource experience
Responsibilities
Facilitate regulatory activities across study lifecycle (start-up, activation, maintenance, closeout), Prepare and coordinate IRB submissions and safety reports, Track regulatory submissions and expirations, Maintain Investigator Site Files (ISFs), Partner with clinical research sites on regulatory requirements, Support site compliance with GCP and FDA regulations, Participate in monitoring visits and audits
Seniority
Mid-level, hands-on IC
