北京 [切换城市] 北京招聘北京生物/制药/医疗器械招聘北京医药技术研发管理人员招聘

SCRA-高级临床监察员-北京

上海日新医药发展有限公司

  • 公司规模：50-150人
  • 公司性质：合资
  • 公司行业：制药/生物工程

职位信息

  • 发布日期：2020-12-08
  • 工作地点：北京-朝阳区
  • 招聘人数：1人
  • 工作经验：5-7年经验
  • 学历要求：本科
  • 语言要求：英语熟练
  • 职位月薪：2-3万/月
  • 职位类别：临床研究员

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
This job description does not list all duties of the job. Employees may be asked by supervisors or management to perform other duties.

任职资格

o Diploma or Degree in Life-Science from a recognized institutions, and/or equivalent combination of training and experience
o Minimum 3.5 years experience in clinical research and fundamental understanding of clinical trial procedure and the regulatory environment.
o Good coordination skills and ability to establish and maintain effective working relationships with all levels within the company and third parties.
o Effective time management and good ability to manage competing priorities
o Good communication skills and must be fluent in both written and spoken English
o Good team player with excellent interpersonal and organizational skills
o High integrity in personality and professionalism
o Positive attitude, high degree of initiative, committed and able to work independently
o Self-initiative to perform duties, with good analytical and problem-solving capabilities
o Ability to handle multiple tasks and expected to follow through with completion of assigned tasks with minimal supervision
o Meticulous and able to work in a fast-paced environment
o Considers the big picture when considering possible opportunity or projects or thinks about long-term application of current activities
o Motivates and empowers others and bring out the best in others
o Able to work under pressure and under challenging timelines when required
o Excellent computer skills and proficient in Microsoft Word, Excel and PowerPoint
o Able to travel when required

职能类别：临床研究员

公司介绍

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


备注：

1） 请通过51job投递应聘简历，谢绝通过其他邮箱投递应聘简历，否则视为无效简历！！！

2） 简历请不要以附件形式发送！！！

联系方式

  • 公司地址：地址：span北三环东路28号15层1508室