Clinical Research Regulatory Coordinator (India)

Clinical Research Regulatory Coordinator (India)

21 Aug
|
Stryde Research
|
India

21 Aug

Stryde Research

India

About Stryde Research
We're a Site Management Organization operating 20+ clinical research sites across Dallas-Fort Worth, Houston, Louisiana, New York, and Current Jersey. We serve 1.5M+ patients through 100+ specialized clinics with deep expertise in dermatology, rheumatology, cardiology, and general medicine. We're scaling fast—going from 22 to 35+ team members in 2026—and need someone who can keep our regulatory house in order across multiple sites and studies.
What You'll Actually Do
Prepare and submit IRB applications, amendments, continuing reviews, and reportable events for multiple sites in US
Maintain essential documents: 1572s, delegation logs, training logs, investigator CVs, medical licenses, financial disclosures
Track and manage IRB approvals, renewals, and expiration dates across 15+ active studies
Coordinate regulatory submissions with sponsors, CROs, and site teams—chase missing documents and keep timelines on track
Ensure sites maintain current regulatory binders (paper and electronic) that are audit-ready at all times
Manage protocol deviations: documentation,



root cause analysis, CAPA implementation, and sponsor reporting
Track site training completion and maintain training files per GCP requirements
Prepare sites for sponsor audits and FDA inspections—conduct regulatory readiness reviews
Communicate regulatory requirements and changes to site coordinators and PIs
Support new site initiations: gather essential documents, IRB submissions, and regulatory activation
You're the Right Fit If:
2+ years in clinical research regulatory role in US IRB must (Adverra or WCG)
Solid understanding of FDA regulations (21 CFR Parts 50, 56, 312), ICH-GCP, and IRB requirements
Experience with central and local IRBs (Advarra, WCG, Sterling, Schulman preferred)
Comfortable managing competing deadlines across multiple studies and therapeutic areas
Detail-oriented enough to catch missing signatures or expired licenses before they become findings
Can work independently an

📌 Clinical Research Regulatory Coordinator (India)
🏢 Stryde Research
📍 India

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