Clinical Research Regulatory Coordinator

2 weeks ago

Bikaner, India Stryde Research Full time

About Stryde ResearchWe'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 DoPrepare and submit IRB applications, amendments, continuing reviews, and reportable events for multiple sitesMaintain essential documents: 1572s, delegation logs, training logs, investigator CVs, medical licenses, financial disclosuresTrack and manage IRB approvals, renewals, and expiration dates across 15+ active studiesCoordinate regulatory submissions with sponsors, CROs, and site teams—chase missing documents and keep timelines on trackEnsure sites maintain current regulatory binders (paper and electronic) that are audit-ready at all timesManage protocol deviations: documentation, root cause analysis, CAPA implementation, and sponsor reportingTrack site training completion and maintain training files per GCP requirementsPrepare sites for sponsor audits and FDA inspections—conduct regulatory readiness reviewsCommunicate regulatory requirements and changes to site coordinators and PIsSupport new site initiations: gather essential documents, IRB submissions, and regulatory activationYou're the Right Fit If:2+ years in clinical research regulatory role with multi-site experienceSolid understanding of FDA regulations (21 CFR Parts 50, 56, 312), ICH-GCP, and IRB requirementsExperience with central and local IRBs (Advarra, WCG, Sterling, Schulman preferred)Comfortable managing competing deadlines across multiple studies and therapeutic areasDetail-oriented enough to catch missing signatures or expired licenses before they become findingsCan work independently and proactively—you don't wait to be told what needs renewal in 30 daysWhat Makes You Stand Out:Experience with dermatology, rheumatology, or cardiology trialsBackground working with SMOs or site networks (you understand coordinating across multiple locations)Familiarity with eTMF systems (Veeva, Florence, Masterfile, or similar)CCRP or ACRP certification showing you're serious about the professionYou've supported successful FDA inspections and know what regulators actually look forThe 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.

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