Senior Clinical Regulatory Specialist — Hybrid & Impact

Seae Ventures; Providence (RI); Hybrid; USD 82,000 - 100,000; Full time

Benefits offered by this job

Hybrid work environment

Medical, dental, and vision coverage

Mental health support

Wellness/professional development stip

401(k) match up to 3%

Job summary

Iterative Health is seeking a Senior Clinical Regulatory Specialist to support the compliant execution of Phase 2–4 industry-sponsored trials across our clinical network. You will provide regulatory guidance and oversight throughout the study lifecycle, from start-up and site activation through maintenance and closeout.

You will partner with clinical research sites, internal teams, sponsors, CROs, IRBs, and other stakeholders to ensure regulatory requirements are completed accurately and

Qualifications

• 4+ years in clinical regulatory and/or research operations for industry trials.
• Experience supporting Phase 2–4 sponsor-initiated trials, site-facing.
• Background as CRC or Regulatory Coordinator with regulatory responsibility.
• Strong knowledge of GCP, FDA regulations, IRB processes, and SOPs.
• Ability to manage regulatory activities across multiple studies/sites independently.
• Experience reviewing regulatory docs for quality and compliance.
• Excellent organization, time management, and prioritization.

Responsibilities

• Oversee regulatory activities across study lifecycle for Phase 2–4 trials.
• Guide research sites on regulatory requirements and submissions.
• Review regulatory documents for completeness, accuracy, and compliance.
• Manage IRB submissions, amendments, continuing reviews, safety reports.
• Monitor timelines and identify potential delays or risks.
• Mentor site teams on regulatory processes and best practices.
• Support training and knowledge sharing for Regulatory Specialists.

Skills

Regulatory oversight

GCP & FDA regs

IRB processes

CTMS experience

Regulatory submissions

Multi-study management

Site collaboration

Education

Bachelor's in life sciences

Tools

CTMS

eSource platforms

Job description

Iterative Health is seeking a Senior Clinical Regulatory Specialist to support the compliant execution of Phase 2–4 industry-sponsored trials across our clinical network. You will provide regulatory guidance and oversight throughout the study lifecycle, from start-up and site activation through maintenance and closeout.

You will partner with clinical research sites, internal teams, sponsors, CROs, IRBs, and other stakeholders to ensure regulatory requirements are completed accurately and