Job Description
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 professional remote work setup
Benefits
Heath care benefits
Please do not apply more than once. Thank you.
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