Clinical Research Site Manager

Clarius Medical GroupSugar Land, TX
Onsite

About The Position

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.

Requirements

  • 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

Nice To Haves

  • 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, eTMF, EDC familiarity (Medidata, Veeva, Florence, or similar)

Responsibilities

  • 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
  • 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
  • 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

Benefits

  • Competitive compensation (based on experience)
  • High-growth environment with direct access to physician leadership
  • Opportunity to build a research site footprint and pipeline from the ground up
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