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Clinical Research Site Manager
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Clarius Medical Group, PLLC
Sugar Land, TX (In Person)
Full-Time
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Job Description
Clinical Research Site Manager (Coordinator + Business Development) Overview Azul BioResearch LLC is an independent clinical research site building a high-performing pipeline in cardiology and specialty trials. We are hiring a hands-on Site Manager who can own daily trial execution while also driving sponsor/CRO relationships, feasibility, and start-up activities. This role requires urgency, strong follow-through, and the ability to operate independently. Key Responsibilities Site Operations and Study Execution Serve as lead coordinator for assigned trials from feasibility through close-out Manage screening, enrollment, visit scheduling, source documentation, EDC entry, query resolution, and TMF/regulatory filing Coordinate patient retention, visit window compliance, and protocol adherence Support monitoring visits, audits, and inspections; manage CAPAs and follow-up items Coordinate lab shipments, imaging, specialty procedures, and outside vendors required by protocol Start-Up and Regulatory Lead feasibility questionnaires, site qualification visits (SQV), SIV readiness, and activation tasks Build and maintain study binders, delegation logs, training logs, equipment calibration logs, and site SOP adherence Coordinate central IRB submissions, continuing review, amendments, safety letters, and reporting requirements Business Development and Study Acquisition Build and maintain a sponsor/CRO pipeline with documented outreach, follow-ups, and meeting cadence Proactively identify trials aligned to our PI specialties and site capabilities Maintain a study pipeline dashboard with weekly KPIs and a clear status for each opportunity Coordinate sponsor/CRO intro meetings, capabilities presentations, and rapid response to feasibility requests Work with leadership to refine site capabilities, vendor readiness, and turnaround times to increase selection likelihood Success Metrics (KPIs) Weekly outreach activity and follow-up completion rate (tracked in a pipeline dashboard) Number of feasibility requests completed on time Time from feasibility request to submission Number of sponsor/CRO intro meetings scheduled per month Study start-up task completion timeliness and reduction of activation delays Data quality metrics: query aging, EDC timeliness, monitoring findings closure rate Required Qualifications 3+ years clinical research experience in a site setting (CRC, start-up, or site management) Demonstrated ability to manage multiple studies and deadlines without close supervision Strong sponsor/CRO communication skills and comfort leading calls Working knowledge of GCP, informed consent, AE documentation, essential documents, and monitoring workflows Strong operational organization: trackers, dashboards, documentation control Preferred Qualifications Prior experience driving feasibility and study acquisition or supporting site growth initiatives Experience with cardiology, nephrology, or specialty trials is a plus Experience coordinating external vendors (imaging, CPET, ophthalmology, specialty labs) CTMS, e