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 rapid-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
Robust written and verbal English communication skills
High attention to detail

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