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 and organizational ability
- Ability to manage multiple priorities in a deadline-driven environment
- Proficiency with Microsoft Office Suite (Word, Excel, Outlook)

Preferred

- Experience supporting U.S.based clinical research organizations or sites

- Familiarity with:

- FDA regulations- ICH-GCP guidelines- eRegulatory systems (such as CRIO)- CTMS or EDC platforms- Experience working remotely with international teams

Work Schedule

- Remote position based in India
- Must have availability overlapping minimum 3-5 U.S. Eastern Time business hours

Additional Information

- This position is open to applicants currently residing in India
- Applicants must have reliable high-speed internet and a qualified remote work setup

Benefits

- Heath care benefits

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