Position Overview:Site Monitoring & Management Independently manage 10–15 investigational sites from start-up through close-outPerform all monitoring visits (SIV, IMV, COV) in accordance with the Monitoring PlanEnsure compliance with protocol, Monitoring Plan, SOPs, and applicable regulations (ISO 14155, FDA, and local requirements)Conduct SDV/SDR, informed consent review, and AE/SAE oversightMaintain full ownership of assigned investigator sites, ensuring successful site management and performanceBuild and maintain strong relationships with Principal Investigators and site staffProvide training, guidance, and ongoing support to site personnelCommunicate effectively to manage queries, provide updates, and drive issue resolutionEnsure data quality, timely query resolution, and site complianceIdentify risks and support audit and inspection readinessCollaborate cross-functionally with Data Management, Clinical, and Project Management teams to support study executionAttend Investigator and/or Coordinator meetingsTeam Support & MentorshipShare expertise and provide guidance to junior CRAs, serving as a resource for questions, problem-solving, and best practicesSupport training initiatives and review work, contributing to team development and consistency across sitesProvide support to upper management as needed, including contributing to study updates, escalations, and operational decision-makingQualifications: 5+ years of CRA experienceStrong medical device experienceMedical device experience, cardiovascular/TEVAR preferredSolid understanding of GCP and FDA regulatory requirementsAbility to work independently and effectively multitask, prioritizing competing activities across multiple sites and study demands50-75% of travel is required for this position.Job SummaryRequisition Number: CLINI002579Job Category: Clinical ResearchSchedule: Full-Time
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