Clinical Research Scientist

Make recommendations regarding monitoring safety, eligibility, enrollment and data consistency. Prepare draft clinical trial reports and draft summaries, abstracts, manuscripts. Has comprehensive understanding of clinical research methodology including study design, protocol writing and CRF preparation. Knowledge of the IND/NDA process is required. Contribute in preparing clinical trial synopses and clinical trial protocols. Draft patient SAE narratives, section of the ISS, ISE, investigator brochure, etc. Contribute to the supervision of monitoring, clinical trial conduct (enrollment, GCP practices, etc.) and preparation of databases for clinical trial reports. Ensure that all assigned studies are conducted according to GCPs and department SOPs.