天津 [切换城市] 天津招聘天津生物/制药/医疗器械招聘天津临床研究员招聘

临床监察员 CRAI/CRAII/Senior CRA

爱恩康临床医学研究(北京)有限公司

  • 公司规模:150-500人
  • 公司性质:外资(欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2019-09-11
  • 工作地点:上海-黄浦区
  • 招聘人数:若干人
  • 工作经验:1年经验
  • 学历要求:本科
  • 职位月薪:1.3-2.1万/月
  • 职位类别:生物工程/生物制药

职位描述

Responsibilities:

Independent and proactive coordination of all the necessary activities required to set up and monitor a study , including but not limited to the following :

Identify investigators. Help when requested , in preparation of regulatory submissions .

Design of patient information sheets and consent forms .

Ensure timely submission of protocol/consent documents for ethics/IRB approval.

Pre study/placement and initiation visits.

Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/sponsor site monitoring SOP, as appropriate Maintain all files and documentation pertaining to studies .

Motivate investigators in order to achieve recruitment targets.

Complete accurate study status reports.

Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.

Keep the Project Manager regularly informed.

Process case record forms to the required quality standards and timelines.

Deal with sponsor generated queries in a timely manner.

Ensure the satisfactory close-out of investigator sites.

Participate, if requested, in the preparation of and review of study documentation , e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report.

Participate in feasibility studies for new proposals as required.

Ensure correct archiving of files on completion of a study.

Maintain patient and sponsor confidentiality .

Assume additional responsibilities as directed by the Project Manager. - lnvestigational Products (IPs) stored and managed by the site.


Requirements:

Tertiary qualification in Science or related field

MUST have at least 2 years monitoring experience

Strong communication and relationship building skills

Good multitasking, time management and prioritization skills

Proactive approach and ability to work autonomously as well as part of a team

Demonstrate professionalism, commitment and passion


Please feel free to reach out to sunshine.yang@docsglobal.com for more details or referrals.

公司介绍

We are a global provider of consulting, and outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.

联系方式

  • Email:sarah.ma@docsglobal.com
  • 公司地址:北京市东城区北三环东路36号环球贸易中心 (邮编:100013)
  • 电话:18810965020