Clinical Regulatory Specialist - Phase 2–4 Trials

Iterative Scopes; Southlake (TX); Hybrid; USD 85,000 - 110,000; Full time

Benefits offered by this job

Hybrid work in NYC or Boston

Medical, dental, vision coverage

401(k) with company match

Wellness stipend

Unlimited PTO and holidays

Job summary

Iterative Health is seeking a Clinical Regulatory Specialist to manage regulatory activities across Phase 2–4 trials. You will partner with clinical sites, sponsors, and CROs to ensure compliant, timely submissions and inspection-ready documentation.

You will support study start-up through closeout, maintain ISFs, and uphold GCP and FDA requirements in a fast-paced, collaborative environment.

Qualifications

• 2+ years in clinical research, regulatory affairs, or related field.
• Experience supporting Phase 2–4 sponsor-initiated trials.
• Regulatory documentation and IRB submission experience.

Responsibilities

• Coordinate study start-up, activation, maintenance, and closeout regulatory activities.
• Prepare and submit regulatory documents to IRBs and governing bodies.
• Maintain ISFs and ensure inspection-ready regulatory records.
• Collaborate with sites, sponsors, CROs, and internal teams to meet timelines.

Skills

Regulatory affairs

GCP knowledge

IRB processes

Documentation control

Regulatory submissions

Tools

CTMS

eSource systems

Regulatory platform

Job description

Iterative Health is seeking a Clinical Regulatory Specialist to manage regulatory activities across Phase 2–4 trials. You will partner with clinical sites, sponsors, and CROs to ensure compliant, timely submissions and inspection-ready documentation.

You will support study start-up through closeout, maintain ISFs, and uphold GCP and FDA requirements in a fast-paced, collaborative environment.