24 Aug
|
Stryde Research
|
India
24 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.
Maintain essential documents: 1572s, delegation logs, training logs, investigator CVs, medical licenses, financial disclosures
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
2+ years in clinical research regulatory role in US IRB must (Adverra or WCG)
~ Experience with central and local IRBs (Advarra, WCG, Sterling, Schulman preferred)
~ Experience with dermatology, rheumatology, or cardiology trials
Background working with SMOs or site networks (you understand coordinating across multiple locations)
You've supported successful FDA inspections and know what regulators actually look for
This is remote but requires overlap with US business hours for sponsor calls, IRB correspondence, and site coordination. Other weeks you're prepping 3 sites for audits while tracking down expired medical licenses. You'll work across time zones with site teams who are busy with patients and
📌 Clinical Research Trial Coordinator (India)
🏢 Stryde Research
📍 India