上海招聘

职位描述：
A) Independently set up an investigator site in a timely manner
o Appropriate investigator site set-up and implementation including
? Coordinate and facilitate investigator site selection
? Conduct Pre-Study Visit
? Fully communicate with site staff about study design, product, and study timeline
? Coordinate and prepare ethics committee & regulatory submissions
? Prepare clinical trial agreements and budget plans
? Coordinate the imports of study drug, lab kits, and equipments and exports of patient’s specimen
? Initiate meeting organization
? Conduct site initiation visit, e.g. set up trial logistics, make sure the site personnel are well-trained and familiar with study procedures…etc

o Set up and update the trial and site information in CTMS and other study management system in a timely manner including in-house administration activities

B) Site Management
o Deliver good quality data in a timely manner
? Attend CRA training, therapeutic area training, and investigator meeting
? Ensure/train site personnel to be familiar with GCP, company’s related policy and SOP, and regulatory requirements
? Conduct site contact, monitoring, and data query resolution and ensure data quality per company standard

o Protect patient’s rights and safety
? Ensure sites conducting study adhere to GCP , SOP and protocol design
? Ensure SAE reporting timeline to meet regulatory and company requirements

o IP management
? Ensure/train site personnel to document IP shipment and accountability timely and correctly
? Ensure the stock and expiry date of IP at site

C) Close investigator sites
o Appropriate investigator site close-out and implementation including
? Conduct site close-out visit
? Fully communicate with investigator about the responsibility of PI after site close-out
? Inform ethics committee & regulatory of site close-out
? Inform study team site close-out if needed

D) Build up the relationship with key partners
o Collaborate closely with study team and sponsors on clinical trial related issues
o Represent the clinical research role & objectives to both internal & external partners (e.g. investigators, KOL) to promote mutually satisfying collaborations
o Prepare and present monthly reports in monthly meeting and share experiences with internal colleagues

E) Perform site feasibility, country feasibility and protocol feasibility
o Support for conduct study feasibility

F) Support to build up a effective team
o Willing to share and teach clinical trial related experiences with junior personnel
o Pay local trial lead role in supporting domestic project management

CRO(Contract Research Organization)是指合同研究组织，为科研单位、制药企业的新药企业的新药开发提供临床试验的企划、运筹等一系列专业服务。随着GCP的运行、新药开发的国际化、特别是在欧美日本等先进国家，CRO以其极强的专业性、中立性、在新药开发中发挥着愈来愈重要的作用。
日本 EPS 株式会社（ EPS Co., Ltd. ）创业于1991年，是日本CRO领域起步早？规模大的CRO企业。2001年7月在日本东京证券市场成功上市，开创了CRO在日本上市的先例。 EPS集团在25年间有了迅速发展，目前已发展成为一个拥有30余家公司，其中两家日本上市企业，近4000员工覆盖全球各区域的跨国集团公司。
上海日新医药发展有限公司是EPS于2001年登陆中国市场，最早引入合同研究组织 (CRO)在华业务的公司。主要从事新药的I到IV期临床试验设计、实施、数据管理、统计分析和分析报告制作等业务，同时开展新药的注册、申报、医药咨询以及市场调研等业务。
本公司于2001年7月在上海正式注册成立，并在北京、广州设有分支机构。现公司设有业务开发、临床开发、注册事务、数据管理、统计分析、市场调查等部门。
凭借在日本从事CRO业务多年的经验，和EPS集团在日本、美国、中国大陆、中国台湾、新加坡等国家和地区的分公司和代表处的雄厚实力，日新公司成长为国内合同研究组织（Contract Research Organization）行业的领军者之一。我们基于中国，面向亚太地区，全面开展全球性的临床研究代理业务。

网址： http://www.eps.co.jp；http://www.epsi-global.com

福利制度介绍:

一 保险类：
1. 养老保险
2. 医疗保险
3. 失业保险
4. 工伤保险
5. 生育保险
6. 住房公积金
7. 补充医疗保险
8. 意外伤害保险
二 制度类：
1. 完整的教育训练
2. 透明化并顺畅的升迁管道
3. 生涯发展规划
4. 多元的海外工作机会
-请/休假制度：
1. 周休二日
2. 年假9-15天/年
3. 入职每满3年, 给予额外的5天长期服务休假奖励
三 其它：
1. 节庆礼品, 生日补贴,
2. 健康体检项目
3. 饭贴, 交通/通信补贴
4. Team Building活动及补助
5. 完善舒适的办公室环境及设备
6. 畅通的沟通渠道和和谐的团队


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