CLINICAL RESEARCH ASSOCIATE

This position is responsible for project management and study site management from site selection to initiation, monitoring, and close-out of assigned clinical studies in accordance with tigermed sponsor standard operating procedures (sops), international conference on harmonization good clinical practice (ich-gcp), clinical practice standards (gcp), and other applicable regulations. the role ensures that all data generated by the sites is of high quality, collected on time, and within budget. responsibilities: study site selection, initiation (siv), and clinical monitoring; provide ongoing training to site staff regarding ich-gcp, gcp, study protocol, and requirements; conduct site initiation to ensure thorough understanding of the study protocol and requirements; ensure timely collection and proper documentation of essential documents during study start-up, conduct, and close-down, maintaining investigator files and trial master files; prepare and archive study records according to protocol and sponsor requirements; disseminate safety information to all sites following sops and regulations; report serious adverse events (saes) within the specified timelines in compliance with sops and regulations; finalize budget and obtain signed contracts prior to site initiation; ensure execution of study payment schedule and retain relevant documentation; update and maintain study tools and systems promptly. qualifications: bachelor's degree or higher in medical, pharmacology, biology, or related fields; good understanding of gcp and clinical trial operations; 1-2 years of clinical re...