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更新于 5月7日

CRAII 臨床監(jiān)查員

1.3-2萬·13薪
  • 廣州越秀區(qū)
  • 登峰
  • 3-5年
  • 本科
  • 全職
  • 招5人

職位描述

腫瘤項(xiàng)目
The Clinical Research Associate (CRA) is responsible for managing and monitoring the conduct of clinical projects according to ICH-GCP, Standard Operating Procedures (SOP) and applicable Project Management Plan (PMP) and local regulatory requirements. Responsibilities: Contribute comments/input in the development of Protocol, Informed Consent Form (ICF), Case Report Forms (CRF) and other project related documents. Evaluation potential sites with the assistance from the senior CRA, PM or line manager and provide PM with recommendations for selection of qualified sites. Prepare the package for institutional review boards (IRB) and local regulatory authority submissions and obtain IRB/regulatory approvals for conducting the clinical trial. Assist PM in start-up meeting. Prepare and manage the clinical trial agreements with investigators/sites. Track, manage and control the site budget and expenses within approved budget and in line with the project milestones as requested. Manage/coordinate the investigational products and clinical trial materials for the sites in compliance with regulatory requirements. Monitor and report the project status at the sites in a timely manner. Key contact person for the communication between the sites and study team. Prepare, arrange and conduct the training of site personnel. 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. Prepare monitoring report according to the SOP. Assist the investigator for auditing/inspection of project. Coordinate with the sites to ensure all adverse events and follow-up are appropriately reported and reconciled according to regulations. Identify, analyze and resolve the issues at the investigator sites. Qualifications: BS (Bachelor of Science) degree or equivalence experience. Advanced degree is a plus. At least 3 years experience in clinical research environment. Good ability of written and spoken in English. Good organization and communication skills. High attention to detail and accuracy.

工作地點(diǎn)

越秀區(qū)廣州醫(yī)科大學(xué)附屬腫瘤醫(yī)院

職位發(fā)布者

閆飛飛/高級(jí)招聘經(jīng)理

昨日活躍
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(tuán)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(guó) 28個(gè)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(zhǎng),是近年來國(guó)內(nèi)規(guī)模發(fā)展最快的 SMO之一。
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