Clinical Research Associate (CRA) - Immunology-Remote

Role: Serve as a Clinical Research Associate (CRA) managing performance and compliance for clinical trial sites within assigned territories in the US (TX, IL, AZ, FL, CA, NY, CO). Objectives include ensuring study conduct aligns with ICH/GCP, country regulations, and company policies, while developing and maintaining strong site relationships. Responsibilities encompass site management, remote and on-site monitoring, regulatory documentation oversight, and troubleshooting performance or compliance issues. The role involves active site development, including identifying and onboarding new sites, and collaborating with cross-functional teams such as regulatory, pharmacovigilance, and regional operations. Requirements: Associate's degree or higher with at least 5 years healthcare experience, including 2+ years in site management in biopharma/CRO, or a bachelor’s degree with 2+ years monitoring experience. Skills include clinical trial methods, site management, GCP/ICH knowledge, data review, and proficiency with clinical systems. Preferred: fluency in local language and English, strong communication, high monitoring competence, and ability to work independently across multiple therapies and protocols. High-value specifics: US-based remote work with 65-75% domestic/international travel (~2-3 days/week). The role emphasizes quality, compliance, and proactive site development, supporting early to late-phase clinical trials in diverse therapeutic areas.