Youv Research is expanding its team and is hiring an experienced Regulatory Document / eTMF Specialist with 2+ years of hands-on experience. This is a fully remote (Work From Home) role, ideal for professionals looking to grow their career in global clinical research projects.
📝 About the Role
As a Regulatory Document / eTMF Specialist, you will play a critical role in ensuring regulatory compliance and maintaining the Trial Master File (TMF) for US-based clinical studies.
🔑 Key Responsibilities
- Study start-up activities including feasibility and site selection
- Regulatory packet submissions
- TMF / ISF maintenance
- Quality Control (QC) and Quality Assurance (QA) of clinical documents
- Conduct audits within a regulatory framework
- Ensure documentation compliance as per ICH-GCP & US regulatory standards
📚 Requirements
- Minimum 2+ years of experience in Regulatory Documentation / eTMF
- Hands-on experience with eTMF tools:
- Veeva
- Wingspan (or similar platforms)
- Strong understanding of clinical research processes
- Immediate joiner preferred
- Good communication and presentation skills
🌈 What Youv Research Offers
- Exposure to global, cutting-edge clinical trials
- Collaborative and supportive work culture
- 100% Remote / Work From Home
- USA business hours (Night shift – IST)
- Excellent career growth opportunities
📧 How to Apply
Interested candidates can apply by sending their updated CV to:
📩 cv@youvresearch.com
📌 Subject Line: Document/eTMF Specialist Application
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🌐 About Youv Research
Youv Research is a fast-growing clinical research organization (CRO) delivering innovative, high-quality solutions to the pharmaceutical and biotech industries worldwide.
🌟 Final Words
If you’re passionate about regulatory documentation, eTMF management, and want to work on US-based clinical studies from home, this opportunity is for you.
👉 Apply now and take the next step in your clinical research career!
