Clinical Research Regulatory Coordinator – Stryde Research (Remote India)

If you’re a clinical research professional looking to build a strong career in clinical regulatory affairs, this new opportunity with Stryde Research could be your next big step. As a rapidly growing Site Management Organization (SMO) operating 20+ sites across the US, Stryde Research is hiring a Clinical Research Regulatory Coordinator to support multi-site regulatory operations, IRB submissions, and compliance documentation.

This is a full-time remote job from India, ideal for candidates with hands-on experience in ICH-GCP, IRB documentation, 1572s, regulatory binders, and multi-site clinical trial coordination.

⭐ Key Responsibilities

As a Clinical Research Regulatory Coordinator, you will:

• Prepare and submit IRB applications, amendments, continuing reviews, and reportable events
• Maintain regulatory essential documents including 1572s, delegation logs, training logs, CVs, medical licenses & financial disclosures
• Track IRB approvals, renewals & expiration dates across 15+ active clinical studies
• Coordinate submissions with sponsors, CROs, and site teams
• Maintain audit-ready regulatory binders (paper + electronic)
• Manage protocol deviations, CAPAs, and sponsor reporting
• Track study training requirements and GCP-compliance training logs
• Prepare sites for sponsor audits and FDA inspections
• Support new site initiations and regulatory activation
• Communicate regulatory changes with site coordinators and PIs

🎯 Required Qualifications

• 2+ years in clinical research regulatory operations (multi-site preferred)
• Strong knowledge of FDA regulations (21 CFR Parts 50, 56, 312), ICH-GCP
• Experience with central/local IRBs – WCG, Advarra, Sterling, Schulman
• Ability to independently manage multiple studies and deadlines
• Strong attention to detail, documentation quality, and audit readiness

💡 Preferred / Added Advantage

• Experience in dermatology, rheumatology, cardiology trials
• Experience working with SMOs or site networks
• Familiarity with eTMF platforms – Veeva, Florence, Masterfile
• CCRP / ACRP certification
• Experience supporting FDA inspections

💼 Why Join Stryde Research?

• Competitive India-based salary
• Fully remote role with US-hours alignment
• Opportunity to work with a fast-growing SMO
• Exposure to multi-site clinical operations + high-impact regulatory work
• Career growth into Senior Regulatory Coordinator / Regulatory Manager roles

📩 How to Apply

Application Link