Clinical Research Associate (CRA) - Immunology-Remote

Role: Clinical Site Manager responsible for overseeing performance and compliance at assigned sites within specified US states, ensuring adherence to ICH-GCP, local regulations, and sponsor policies. Main objectives include site development, monitoring, regulatory documentation management, and maintaining strong site relationships throughout all trial phases. Responsibilities encompass remote and on-site monitoring, protocol adherence, issue resolution, and collaboration with cross-functional teams including regulatory affairs and site vendors. The role also involves identifying and developing new sites, supporting audits, and acting as subject matter expert on monitoring processes. Requirements include an Associate's or Bachelor's degree in a healthcare/scientific field, with 5+ years of healthcare experience and at least 2 years in site management or clinical monitoring within biopharma/CRO. Key skills involve GCP/ICH knowledge, clinical trial management, data analysis, and excellent communication in English and local languages. The position demands 65-75% travel domestically and internationally, a valid driver’s license, and the ability to work independently in a remote setting. High-value biopharma specifics include strong familiarity with clinical research regulations, multi-phase trial oversight, site performance management, and experience across therapeutic areas. The role is senior-level, requiring demonstrated monitoring expertise, problem-solving, and stakeholder management.