- 工作地点：上海
- 职位：临床研究监察员
- 信息来源：复旦大学
说明：
职位类别:科学研究人员此信息由复旦大学审核并发布（查看原发布网址），应届生求职网转载该信息只是出于传递更多就业招聘信息，促进大学生就业的目的。如您对此转载信息有疑义，请与原信息发布者复旦大学核实，并请同时联系本站处理该转载信息。
学历要求:硕士及以上
招聘人数:2人
工作地点:张江亮景路199号
投递邮箱:jiayun.zhu@
单位介绍:
Company introduction:nFounded in October 2017, Dizal Pharmaceutical is a research-d biotechnology company dedicated to the discovery, development and commercialization of first-in-class/best-in-class medicines.nDizal Pharmaceutical, formerly known as Asia and Emerging Markets, Innovative Medicines and Early Development, AstraZeneca (AEM iMED), was founded in Shanghai, China. One of AstraZeneca’s four global research operations (the other three being located in Cambridge, UK, Gothenburg, Sweden, and Gaithersburg, USA, respectively), Dizal Pharmaceutical is a cutting-edge, high-yield R&D center for innovative drugs, equipped with world-leading translational medicine platforms as well as new-drug molecular design and screening platforms. Dizal Pharmaceutical has accumulated extensive experience in the development of innovative therapies for the treatment of cancer, autoimmune diseases and chronic kidney disease among others.nnnCompany website: ww***com[点击查看]
职位描述:
Responsibility
? Be responsible for the delivery of the studies at allocated sites and works in close collaboration with other CRAs and the local study delivery team to ensure that quality and quantity commitments are achieved in a timely and efficient manner.
? Conduct site feasibility assessment.
? Contribute to the selection of potential investigators and leading investigator.
? Contribute to national Investigator meeting.
? Obtain and maintain essential documentation in compliance with GCP, ICH-GCP, Company documents and local regulations both in the office and at site.
? Actively participate in local Study Team meetings.
? Train, support and advice Investigators and site staff in study related matters.
? Initiate, monitor and close study sites in compliance with Company Documents. Share information on patient recruitment and study site progress within local Study Team.
? Drive performance at the sites.
? Update study related systems with data from sites per required timelines.
? Manage study supplies, drug supplies and drug accountability at study sites.
? Perform source data verification. Proactively identify study-related issues and escalates as appropriate.
? Complete monitoring visit reports within required timelines. Document the issues and follow up with sites until it is resolved.
? Ensure accurate and timely reporting of Serious Adverse Events.
? Work with data management to ensure quality of the study data. Ensure data query resolution.
? Prepare for activities associated with audit and regulatory inspection at responsible sites in liaison with local study team lead and QA.
? Ensure compliance with company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
Job Requirement
? University degree in related discipline, preferably in life science, equivalent qualification.
? At least 2-years clinical research working experience in multinational pharmaceutical companies multinational CROs is preferred.
? Fluent knowledge of spoken, read and written English.
? Excellent knowledge of international guidelines ICH/GCP.
? Good knowledge of relevant local regulations.
? Good medical knowledge and basic understanding of the drug development process.
? Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
? Ability to travel nationally as required.
