任女士
4天前在线
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- 职位介绍
- CRA
- GCP认证
- 临床监察员CRA Major Responsibilities and Duties 1. Ensure all business is conducted professionally in compliance with company policies and procedures. 2. Maintains working knowledge of protocols and Monitoring Plans for assigned projects. 3. Responsible for leading the EC submission team for GCP office pre-review and EC submission to meet start up timeline. 4. Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period; 5. Responsible for scheduling and conducting of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan. 6. Ensures assigned sites are conducting studies according to protocol requirements. 7. Reconciles site regulatory binder assuring collection and completeness of regulatory documents. 8. Collects and ensures completeness of all essential regulatory documentation from sites from study start-up through close-out. 9. Verifies that written informed consent was obtained before each subject’s participation in the trial; 10. Verifies that the investigator is enrolling only eligible subjects. 11. Performs verification of source document s against Case Report Form/Electronic Data Capture entries to assure accurate and complete data. Ensures that any corrections are appropriately documented by authorized site staff. 12. Issues and ensures timely resolution of all data queries. Qualifications 1. Bachelor degree or above, Education with medical or pharmacy background. 2. More than 1 year CRA working experience on oncology study will be preferred. 3. Good written and verbal communications skills both in Chinese and English. 4. Good computer skills. 5. Self-motivated, have team-spirit, can work under pressure. 6. Ability to travel as required.
- 其他信息
- 所属部门：Clinical Operation
公司简介
应世生物创立于2018年，是一家处于临床研发阶段的生物科技新锐。公司以疾病生物学为创新源头，聚焦突破肿瘤的耐药和转移特别是抗PD1耐药，深入布局针对肿瘤微环境的新药研发领域，致力于打造临床转化与概念验证的高效引擎，成为一家立足中国并产生全球影响的新药研发公司。公司建立了跨上海、北京、南京、美国、加拿大和澳洲的高水平转化医学与临床开发团队，公司以共同研发， 产品引进， 及自身研发的多种方式， 构建起了高度差异化， 并由内在协同效应的具有全球权益的研发管线，以实现“联合用药研发”策略。并同包括默沙东、罗氏和勃林格殷格翰在内诸多跨国药企及国内外生物技术公司达成了合作伙伴关系。
公司的核心团队曾在罗氏、诺华、默沙东、先灵葆雅、葛兰素史克、强生、百济神州等跨国药企担任高级研发和管理职位，拥有涵盖创新药物的研究、开发、临床转化、概念验证、再到产品上市的全部环节的丰富经验，曾带领团队完成包括可瑞达（帕博利珠单抗注射液，英文名Keytruda）、佳达修（人乳头瘤病毒疫苗，英文名Gardasil）等在内的十多种药物在中国的临床开发与注册上市。我们已经初步建立起一系列具有显著临床价值和协同效应的研发管线，同时持续积极寻找对外授权许可或合作开发的机会，大限度地丰富和优化产品组合，为患者带来真正的高水平临床获益。
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