勤務エリア

業種

職種

雇用形態

年収

Clinical Research Associate

募集要項

年収 500万~1000万
雇用形態 正社員
職種 前臨床研究(薬物動態)
仕事内容 Clinical Research Associate is responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, with or without guidance; liaise with vendors; and other duties

【Responsibilities】
•General On-Site Monitoring Responsibilities:
•Perform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on our or client data management systems, as assigned by management
•Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management
•Generate and track drug shipments and supplies, as needed
•Track and follow-up on serious adverse events as assigned
•Attend investigators’ meetings, project team meetings and teleconferences, as needed
求める人材 【求める条件】
•University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
•Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP
• At least two years experience in support of clinical research project teams for a CRO or pharmaceutical/ biotech company

会社情報

会社名 会社名は非公開です
業種 食品
資本金 251億2200万円
従業員数 -