Internal Monitoring Gcp

21 hours ago

Ajmer, India Whatjobs IN C2 Full time

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. Our competitive edge? 30% faster study startup and 40% faster enrollment than industry standard—but only if quality doesn’t slip. What You’ll Actually Do - Conduct remote monitoring of site regulatory binders, source documentation, and protocol compliance - Perform source data verification (SDV) comparing CRFs against source documents (EMRs, labs, procedure notes) - Audit essential documents: 1572s, training logs, delegation logs, IRB correspondence, investigator CVs/licenses - Track quality KPIs and Generate quality scorecards by site and coordinate—flag issues before they escalate - Identify trends across sites and develop targeted training on GCP, protocol requirements, and documentation standards - Own CAPA process from identification through effectiveness checks - Prepare sites for sponsor audits and regulatory inspections through remote review and mock inspections - Review informed consents, inclusion/exclusion verification, AE reporting, and IP accountability - Provide real-time quality support to site coordinators and leads You’re the Right Fit If: - 2+ years as a CRA, senior CRC, or quality role in clinical research with hands-on site experience - Deep knowledge of ICH-GCP, FDA regulations (21 CFR Parts 11, 50, 56, 312) - Experience preparing sites for FDA inspections and sponsor audits - Comfortable working remotely across multiple time zones with US-based sites - Can review regulatory binders and identify gaps quickly and accurately - Strong in data analysis and trend identification across multiple sites What Makes You Stand Out: - Experience in dermatology, rheumatology, or cardiology trials - Background in SMO or site network quality functions - Successfully supported FDA inspections with zero findings The Reality Check: This is 100% remote but requires US hours overlap for site coordination calls and real-time support. You’ll balance being thorough (can’t miss critical findings) with being practical (not every documentation preference needs a CAPA). Our site teams are smart and care about quality—you’re their safety net and coach, not the compliance police. When you find issues, you explain why it matters for patient safety and data integrity, not just cite regulations. Compensation & Growth: Competitive salary based on experience. Fully remote with flexibility for India-based hours (2nd shift) but requires availability during US business hours for key coordination. Clear metrics: quality scorecard improvement, findings closure rates, audit readiness scores. We’re building quality infrastructure to support aggressive growth.

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