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:
- 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:
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
- eRegulatory systems (such as CRIO)
- 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 professional remote work setup
Benefits
Please do not apply more than once. Thank you.
