Monroe Biomedical Research Hiring Regulatory Support Specialist – Remote (WFH India)
Are you seeking Monroe Biomedical Research careers in India, remote regulatory affairs support vacancies, or study start-up clinical operations jobs from home? Clinical trial organization Monroe Biomedical Research is hiring a Regulatory Support Specialist for its remote clinical operations unit in India.
This clinical study documentation compilation, Institutional Review Board (IRB) submission support, electronic regulatory binder (eRegulatory) upkeep, investigator credential verification, and GCP compliance auditing vacancy operates under a fully remote model anywhere in India. The position is open to life sciences, nursing, biology, and pharmacy graduates holding Bachelor's or Master's degrees. Candidates with 1+ years of experience in clinical trial administration, regulatory operations, or study start-up—preferably supporting U.S. clinical studies or using CRIO eRegulatory databases—are encouraged to apply. To design a professional ATS-friendly resume detailing your essential documents logging, IRB amendments tracker, or site file audits, review our guide on how to apply for healthcare and pharma jobs online.
📋 Job Overview
- Company: Monroe Biomedical Research
- Position: Regulatory Support Specialist
- Department: Clinical Operations / Study Start-Up
- Job Location: Remote (Anywhere in India)
- Employment Type: Full-Time
- Experience: 1+ Years Preferred (Clinical research or regulatory documentation)
- Qualifications: B.Pharm / M.Pharm / Pharm.D / B.Sc / M.Sc Life Sciences or relevant scientific degree
- Reporting Manager: Polly Turner (Regulatory & Study Start-Up Manager)
- U.S. Time Overlap: Must overlap 3–5 hours of U.S. Eastern Time business hours
💼 Key Responsibilities
- Regulatory Documentation: Support the compilation, tracking, and organization of essential trial documents, including IRB submissions and amendments.
- eRegulatory Binder Management: Organize and update electronic regulatory binders (eRegulatory) using CRIO or related platform configurations.
- Credential Collection: Collect, review, and track investigator CVs, professional medical licenses, GCP training records, and financial disclosures.
- Site Activation Support: Coordinate with U.S.-based study coordinators to track regulatory approvals and document expirations.
- Inspection Readiness: Audit regulatory files regularly to ensure study binders are complete and meet FDA and ICH-GCP quality requirements.
- Cross-Functional Collaboration: Partner alongside U.S. regulatory managers, investigators, and sponsor monitors to resolve documentation queries.
To learn about standard regulatory affairs questions, dossier reviews, and international agency workflows, see our guide on how to Crack Your Regulatory Affairs Interview.
🎓 Required Qualifications & Skills
- Education: Bachelor's or Master's degree in Pharmacy, Life Sciences, or equivalent healthcare field.
- Experience Range: 1+ years of experience in clinical research operations, trial documentation management, or regulatory support.
- Standards Knowledge: Understanding of U.S. FDA regulations, ICH-GCP guidelines, and Institutional Review Board (IRB) procedures.
- Software Literacy: Experience operating eRegulatory portals (like CRIO), CTMS platforms, or electronic data capture (EDC) systems.
- Communication: High fluency in written and spoken English for coordinating with international U.S. teams.
- Infrastructure: Dedicated home office setup, reliable high-speed internet, and ability to work overlapping U.S. Eastern business hours.
To learn about how site start-up operations correlate with clinical study sites, monitoring procedures, and trial protocols, read our detailed Clinical Research Coordinator (CRC) Guide.
🎁 Why Join Monroe Biomedical Research?
- 100% remote work-from-home model anywhere in India, offering excellent flexibility.
- Direct operational exposure to U.S.-based clinical trials and FDA regulatory frameworks.
- Collaborate daily with international clinical operations managers and research investigators.
- Comprehensive healthcare benefits and competitive remote-working salary structures.
📝 Resume Tips for Monroe Biomedical Candidates
- Detail U.S. CRO Experience: If you have worked with U.S. studies, specify the therapeutic areas and the regulatory platforms used.
- Specify eRegulatory Platforms: Clearly name systems like CRIO, Veeva Vault, or custom CTMS tools you have operated.
- Use Target Keywords: Highlight terms like IRB Submissions, eRegulatory Binders, Document Tracking, FDA Compliance, and ICH-GCP.
💬 Monroe Biomedical Regulatory Specialist Interview Questions
- Q1. What are "essential documents" in clinical trials according to ICH-GCP E6?
Answer Guidance: Essential documents are those that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. They serve to demonstrate the compliance of the investigator, sponsor, and monitor with GCP standards. They are divided into three parts: before clinical phase start, during trial conduct, and after completion. - Q2. How do you manage electronic regulatory binders (eRegulatory) to maintain audit readiness?
Answer Guidance: I ensure every document is named consistently according to naming conventions, filed in the correct folder, and holds valid electronic signatures. I set up trackers for expiration dates of licensing certificates or training logs, requesting updates at least 30-60 days before expiration to prevent document gaps. - Q3. Explain the difference between an IRB amendment and a continuing review.
Answer Guidance: An IRB amendment is a request submitted when there are changes made to the approved protocol, consent forms, or investigator documents during the study. A continuing review is a periodic report (usually annual) submitted to the IRB to review the progress of the study and verify that the risk-benefit ratio remains acceptable for ongoing trial subjects.
📖 How to Apply?
Before submitting your application, please read our step-by-step guidance on how to navigate the BambooHR registration portal, fill out required forms, and format your application profile:
📄 Premium ATS Resume Builder Service
Want to build a professional ATS-friendly resume tailored for Clinical Regulatory Affairs, Study Start-Up, or Clinical Operations roles? Message us directly on our LinkedIn Company Page with the phrase "I want Resume Builder Service", and our expert team will connect with you:
📲 Message Us on LinkedIn🚀 Direct Application Link
If you are ready with your documents, apply directly via the official Monroe Biomedical Research BambooHR recruitment portal:
Apply Online – Monroe Biomedical Careers (Regulatory Specialist)📄 Try Free ATS Resume Analyzer & Builder
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🚀 Launch Free ATS Resume Tool❓ Frequently Asked Questions
Q. Is this position hybrid or 100% remote?
This is a 100% remote work-from-home position available for candidates residing anywhere in India.
Q. What is the required work schedule for this Indian remote role?
Candidates must have a reliable home office setup and a work schedule that overlaps 3 to 5 hours of U.S. Eastern Time business hours.
Q. What specific software systems are preferred for this position?
Familiarity with the CRIO eRegulatory system, clinical trial management systems (CTMS), and electronic data capture (EDC) platforms is highly preferred.
