SeniorClinicalResearchAssociate/CRA-FSP

## Accountabilities Conduct site monitoring activities including site initiation, routine monitoring visits, and close-out visits in accordance with the Study Monitoring Plan and applicable regulations. Serve as the primary liaison for assigned investigator sites, ensuring effective communication and timely resolution of site-level issues. Ensure compliance with ICH-GCP, study protocols, and regulatory requirements while safeguarding patient safety and data integrity. Support site activation, recruitment, and enrollment activities in collaboration with study teams and site care partners. Monitor adverse events (AEs) and serious adverse events (SAEs), ensuring timely reporting and resolution in coordination with safety teams. Maintain accurate and timely study documentation, including monitoring reports, TMF updates, follow-up letters, and site communication records. Identify, document, and resolve site issues, developing corrective and preventive actions (CAPAs) where required. Oversee investigational product handling at site level, including storage, accountability, and compliance with protocol requirements. Support database lock activities and contribute to overall study execution quality and timelines. Participate in audit and inspection readiness activities, including CAPA implementation and quality event remediation. Requirements: Minimum 3+ years of clinical research monitoring experience, preferably including exposure to oncology or other complex therapeutic areas. Strong knowledge of ICH-GCP guidelines, clinical trial operations, and applicable regulatory requirements (FDA and local authorities). Bachelor’s degree in life sciences or related field (nursing, pharmacy, or medical background preferred). Proven ability to manage investigator site relationships and resolve operational issues independently. Strong understanding of clinical trial processes from site initiation through close-out. Excellent communication skills with fluency in English and local langu