Senior Clinical Research Associate II

Role: Senior Clinical Research Associate II responsible for managing investigator sites to ensure compliant and quality conduct of clinical trials, primarily in oncology or related therapeutic areas. Objectives include site monitoring, safeguarding patient safety, maintaining site engagement, and ensuring trial timelines and data integrity. Responsibilities encompass site initiation, routine monitoring, issue resolution, and close-out activities, along with training and supporting site staff on protocol adherence. The role involves interfacing with study teams, managing regulatory compliance, and supporting audit readiness. Qualifications: Bachelor’s degree in life sciences or related field; minimum 5 years of clinical research site monitoring experience, preferably in oncology; extensive knowledge of ICH/GCP, FDA, and local regulations; and global trial experience. Skills include strong communication, risk assessment, and team leadership abilities. Preferred: fluency in English and the local language, and experience with site development and study oversight in complex trials. High-value specifics: focus on oncology, vaccine, or infectious disease studies; Phase 1-3 trials; significant international travel (60-80%). The role may include mentoring junior staff and serving as a Subject Matter Expert (SME). Work setup involves travel within the cluster, with some international and weekend travel as required.