Regulatory Specialist: Phase 2-4 Clinical Trials

TAU Ventures; Southlake (TX); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work environment

Excellent health coverage

Wellness program

Job summary

Iterative Health, a healthcare technology and services company, seeks a Clinical Regulatory Specialist to support compliant execution of Phase 2-4 industry-sponsored trials across our network.

You will partner with clinical sites, sponsors, CROs, IRBs, and internal stakeholders to ensure regulatory requirements are completed accurately and efficiently, with a focus on inspection-readiness and timelines.

Qualifications

• 2+ years of regulatory, clinical operations, or related experience supporting industry-sponsored trials.
• Experience supporting Phase 2-4 sponsor-initiated trials, ideally in site-facing regulatory capacity.
• Previous site-facing regulatory role with responsibility for regulatory activities.
• Working knowledge of GCP, FDA requirements, IRB processes, and SOPs.
• Experience preparing and maintaining essential regulatory documents and supporting IRB submissions.

Responsibilities

• Coordinate regulatory activities across the study lifecycle for Phase 2-4 trials.
• Prepare, collect, review, and maintain regulatory documents for study activation and ongoing compliance.
• Coordinate initial IRB submissions, amendments, continuing reviews, safety reports, and other submissions.
• Track submissions, approvals, expirations, and documentation to meet timelines.
• Maintain Investigator Site Files and other regulatory documentation, inspection-ready.

Skills

Regulatory affairs

Clinical trials

Site coordination

GCP knowledge

IRB submissions

Documentation

CTMS usage

Tools

CTMS

eSource

Job description

Iterative Health, a healthcare technology and services company, seeks a Clinical Regulatory Specialist to support compliant execution of Phase 2-4 industry-sponsored trials across our network.

You will partner with clinical sites, sponsors, CROs, IRBs, and internal stakeholders to ensure regulatory requirements are completed accurately and efficiently, with a focus on inspection-readiness and timelines.