Clinical Research Associate

The Clinical Research Associate supports the planning, coordination, and execution of clinical studies across multiple sites, ensuring studies are conducted in compliance with GCP, FDA, ISO 14155, and regulatory requirements. This role partners with clinical sites, internal teams, and vendors to manage study operations, EDC data quality, regulatory documentation, and site coordination from study start-up through closeout. Responsibilities Support clinical study start-up, execution, monitoring, and closeout activities across one or more study sites. Coordinate day-to-day study operations with clinical sites, CROs, vendors, and internal cross-functional teams. Perform EDC monitoring, CRF review, query management, data reconciliation, and centralized data review activities. Maintain study trackers, enrollment reports, dashboards, timelines, and operational metrics. Prepare and maintain study documentation, including protocols, informed consent forms, CRFs, source documents, training materials, and study reports. Manage Trial Master File (TMF) documentation and support IRB submissions, regulatory documentation, and inspection readiness. Track enrollment, patient visits, protocol deviations, adverse events, device deficiencies, and study supplies. Support patient recruitment, prescreening, scheduling, registry updates, and clinical research database activities. Coordinate study budgets, contracts, vendor activities, clinicaltrials.gov submissions, and study-related documentation. Ensure studies are conducted in compliance with Good Clinical Practice (GCP), FDA regulations, ISO 14155, IRB requirements, and company procedures. Requirements Bachelor's degree in Life Sciences, Health Sciences, Nursing, Public Health, or a related field. Minimum of 2 years of experience as a Clinical Research Associate (CRA), Clinical Research Coordinator (CRC), or similar clinical research role. Experience supporting clinical study operations, EDC systems, data review, query management, and clinical study documentation. Strong understanding of GCP, informed consent, adverse event reporting, protocol deviations, Trial Master File (TMF) management, and clinical monitoring processes. Experience supporting study start-up, site coordination, enrollment tracking, and study closeout preferred. CRA certification (CCRA, CCRP, or CCRC), GCP certification, and medical device clinical research experience are preferred. Experience in sleep medicine, respiratory medicine, or related healthcare environments is a plus. Proficiency with Microsoft Office and EDC systems, with strong organizational, documentation, and communication skills. Ability to manage multiple studies simultaneously and travel approximately 30% to clinical sites. Pay Rate $40-50/hr #J-18808-Ljbffr Cypress HCM