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 laws, and company policies across all trial phases. Responsibilities include developing strong site relationships, managing site monitoring activities (remote and on-site), coordinating study start-up tasks, and supporting site selection and validation. The role involves regulatory documentation oversight, issue resolution, and collaboration with cross-functional teams such as regulatory affairs, pharmacovigilance, and external vendors. The candidate acts as SME for monitoring processes, contributes to audits/inspections, and supports site development efforts. Travel of approximately 65-75% domestically and internationally is required, with frequent visits (~2-3 days/week). Qualifications include at least 5 years of healthcare or clinical research experience, with 2+ years of direct site management in pharma/CRO, an associate's or bachelor's degree in a healthcare/scientific field, and proficiency in clinical trial monitoring, GCP, and regulatory compliance. Fluency in local languages and English, strong communication, IT skills, and experience managing complex issues are essential. The position demands high independence, organizational skills, and cultural sensitivity, with a focus on patient safety, data integrity, and high-quality trial conduct. The work setup is remote, with significant travel, and the role targets candidates residing in Texas, Illinois, Arizona, Florida, California, NY, or Colorado.