Department: Clinical Operations
Reports to: Polly Turner, Regulatory & Study Start-Up Manager
FLSA Status: Full time
Location: Remote
- India

_ This is a fully remote position open to applicants currently residing anywhere in India._
- About Monroe Biomedical Research

At Monroe Biomedical Research, we are committed to advancing healthcare through high-quality clinical research. As we continue to grow, we are seeking a highly organized and detail-oriented Regulatory Coordinator Assistant based in India to support our U.S. clinical research operations remotely.

This role is ideal for someone who thrives in a fast-paced environment, enjoys process-driven work, and is passionate about accuracy, compliance, and operational excellence in clinical research.
- Key Responsibilities
- Regulatory Support
- Assist with preparation and submission of regulatory documents including:
- IRB submissions- Amendments- Continuing reviews- Essential study documentation
- Maintain accurate and audit-ready electronic regulatory files (eRegulatory binders)
- Track submission timelines, approvals,



expirations, and regulatory milestones
- Support collection and organization of:
- CVs- Medical licenses- Training documentation- Site essential documents

Compliance & Study Operations
- Support clinical study start-up and activation activities
- Ensure documentation aligns with FDA regulations, ICH-GCP guidelines, and company SOPs
- Assist with audit and inspection readiness activities
- Help maintain regulatory tracking logs and reporting tools

Cross-Functional Collaboration
- Coordinate with U.S.based clinical and regulatory teams
- Communicate regulatory updates and document requests in a timely manner
- Support operational efficiency across multiple clinical studies and sites

Qualifications
- Required
- 1+ years of experience in clinical research, regulatory support, or healthcare administration preferred
- Strong written and verbal English communication skills
- High attention to detail

📌 Regulatory Support Specialist (Bengaluru)
🏢 Monroe+Biomedical+Research
📍 Bengaluru