23 Aug
|
Stryde Research
|
Uttar Pradesh
23 Aug
Stryde Research
Uttar Pradesh
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 1.5 M+ 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 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 with multi-site experience 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 and proact
📌 Clinical Research Regulatory Coordinator (Uttar Pradesh)
🏢 Stryde Research
📍 Uttar Pradesh