Clinical Research Regulatory Specialist

About Stryde Research

We're a Site Management Organization operating 20+ clinical research sites across Dallas-Fort Worth, Houston, Louisiana, New 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
• 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 :

What Makes You Stand Out :

The Reality Check :

This is remote but requires overlap with US business hours for sponsor calls, IRB correspondence, and site coordination. Some weeks you're submitting 5 different IRB amendments. 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 study visits—your job is to make regulatory compliance as painless as possible for them.

When a site coordinator emails you at 8pm their time because they just realized an IRB approval expires tomorrow, you need to know exactly what emergency procedures to follow. When a sponsor changes a protocol mid-study, you're coordinating amendments across multiple IRBs with different submission requirements.

Compensation & Growth :

Competitive salary based on experience. Fully remote from India with flexibility but requires availability during US business hours for critical coordination.