Clinical Research Associate (CRA) - Immunology-Remote

Role: The Clinical Site Manager oversees performance and compliance of assigned clinical trial sites across specified U.S. states, ensuring adherence to ICH-GCP, local regulations, and company policies throughout all trial phases. Responsibilities include developing strong site relationships, managing site activities, participant recruitment, regulatory documentation, and oversight through remote and onsite monitoring, including validation, initiation, and close-out visits. The role involves collaboration with cross-functional teams such as regulatory, pharmacovigilance, and legal, and supports site selection and development efforts. The manager acts as SME for monitoring processes, contributes to audits/inspections, and maintains accurate documentation in CTMS and eTMF systems. Travel of 65-75% domestically and internationally, approximately 2-3 days per week, is expected. Requirements include an Associate's or Bachelor’s degree in a healthcare/science discipline with at least 5 years (Associate’s) or 2 years (Bachelor’s) of healthcare and site monitoring experience in biopharma or CRO. Core skills required are knowledge of GCP, clinical trial management, site performance, and monitoring tools, with fluency in English and local languages. The role demands high independence, excellent communication, organizational skills, and the ability to manage complex issues across multiple protocols and therapy areas. The position is remote with significant travel, and candidates must reside in specified U.S. states.