23 Aug
|
Stryde Research
|
Bengaluru
23 Aug
Stryde Research
Bengaluru
About Stryde Research
We're a Site Management Organization operating 20+ clinical research sites across Dallas-Fort Worth, Houston, Louisiana, Recent York, and New 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 current 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 fin
📌 Clinical Research Regulatory Coordinator (Bengaluru)
🏢 Stryde Research
📍 Bengaluru