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臨床監(jiān)查員CRA（北京）

1.1-1.8萬·13薪
  • 北京朝陽區(qū)
  • 3-5年
  • 本科
  • 全職
  • 招1人

職位描述

藥品臨床監(jiān)查新藥Ⅰ期Ⅱ期Ⅲ期GCP認(rèn)證GCP證書
Responsibilities:
1、Contribute comments/input in the development of Protocol, Informed Consent Form (ICF), Case Report Forms (CRF) and other project related documents.
2、Evaluation potential sites with the assistance from the senior CRA, PM or line manager and provide PM with recommendations for selection of qualified sites.
3、Prepare the package for institutional review boards (IRB) and local regulatory authority submissions and obtain IRB/regulatory approvals for conducting the clinical trial.
4、Assist PM in start-up meeting.
5、Prepare and manage the clinical trial agreements with investigators/sites. 6、Track, manage and control the site budget and expenses within approved budget and in line with the project milestones as requested.
7、Manage/coordinate the investigational products and clinical trial materials for the sites in compliance with regulatory requirements.
8、Monitor and report the project status at the sites in a timely manner.
9、Key contact person for the communication between the sites and study team.
10、Prepare, arrange and conduct the training of site personnel.
11、Conduct site initiation, monitoring and site close-out visits in compliance with monitoring plan, ICH-GCP, SOPs, local regulations and other applicable project-specific plans.
12、Prepare monitoring report according to the SOP.
13、Assist the investigator for auditing/inspection of project.
14、Coordinate with the sites to ensure all adverse events and follow-up are appropriately reported and reconciled according to regulations.
15、Identify, analyze and resolve the issues at the investigator sites.

Qualifications:
1、A 4-year BS (Bachelor of Science) degree or equivalence experience. Advanced degree is a plus.
2、At least 1 year experience in clinical research environment.
3、High attention to detail and accuracy.
4、Good organization and communication skills.
5、Good command of written and spoken in English or other second language.

職位福利：五險一金、餐補、交通補助、彈性工作、帶薪年假、通訊補助、定期體檢、

獎金績效

五險一金、餐補、交通補助、彈性工作、帶薪年假、通訊補助、定期

工作地點

漢威大廈

職位發(fā)布者

鄔女士/HR

三日內(nèi)活躍
立即溝通
公司Logo南京立順康達(dá)醫(yī)藥科技有限公司
康達(dá) SMO是 Novotech Health Holdings集團全資控股的臨床中心管理組織，在上海、北京、南京、廣州、深圳、杭州等地設(shè)有分公司及辦事處。業(yè)務(wù)覆蓋至全國 28個省、自治區(qū)和直轄市。自 2017年成立以來，康達(dá) SMO的業(yè)務(wù)在飛速增長，是近年來國內(nèi)規(guī)模發(fā)展最快的 SMO之一。
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