Senior Clinical Research Associate - Early-Stage Development (ESD) (REMOTE)

Role: Senior Clinical Research Associate (CRA) responsible for site performance, compliance, and management in clinical trials, primarily within a specified country. Objectives include ensuring study conduct aligns with ICH-GCP, regulations, and company policies, while developing strong site relationships and expanding the research territory. Responsibilities encompass on-site and remote monitoring, regulatory documentation oversight, issue resolution, and collaboration with cross-functional teams such as regulatory, pharmacovigilance, and legal. The role involves mentor/mentee activities, process SME contributions, and supporting audits. High-value specifics include extensive travel (65-75%), fluency in local language and English, 7+ years in healthcare with 4+ years direct site management experience, and proficiency in GCP/ICH, clinical trial documentation, patient recruitment, and data management. The position requires an associate's or bachelor’s degree in a healthcare/scientific discipline, experience in bio/pharma/CRO settings, and driver’s license. Focus areas include Phase 1-3 trials, site management, and compliance oversight, with the role based remotely in the US or Puerto Rico. It demands strong communication, independent judgment, problem-solving, and cultural sensitivity skills.