Clinical Research Associate (CRA) - Immunology-Remote

Role: Field-based Clinical Research Associate (CRA) responsible for site management, monitoring, and compliance in clinical trials across specified US states. Objectives include ensuring study conduct adherence to ICH-GCP, country regulations, and company policies, while developing strong site relationships and expanding the clinical research network. Responsibilities encompass remote and on-site monitoring, site qualification, regulatory documentation oversight, and issue resolution; collaborating with cross-functional teams and external vendors; and supporting audits and inspections. Requirements: Associate's degree or higher in a healthcare/scientific field with 5+ years of healthcare experience, including 2+ years in site monitoring within biopharma/CRO; or a bachelor's degree with 2+ years of site management experience. Skills include proficiency in clinical research methods, adverse event reporting, regulatory compliance, and site management tools; fluency in English and local languages; strong communication, organizational, and problem-solving abilities. High-value specifics: the role involves extensive travel (~65-75%), with a focus on clinical trial conduct in therapeutic areas relevant to biopharma; familiarity with GCP/ICH guidelines, regulatory documentation, and site performance metrics. Work setup is remote with significant travel; candidate must possess a valid driver’s license. The position emphasizes independence, cultural sensitivity, and high-quality compliance in a matrixed, multicultural environment.