更新于 2月11日
职位描述
CRA新药Ⅰ期Ⅱ期Ⅲ期
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.
As a Clinical Research Associate II at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.
As a Clinical Research Associate II at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.
You will:
- Conduct and report SSV, SIV, RMV, COV onsite monitoring visits
- Perform CRF review, source document verification and query resolution
- Be responsible for site communication and management
- Be a point of contact for in-house support services and vendors
- Communicate with internal project teams regarding study progress
- Participate in feasibility research
- Support regulatory team in preparing documents for study submissions
- Prepare and participate on audits and inspections
- Conduct and report SSV, SIV, RMV, COV onsite monitoring visits
- Perform CRF review, source document verification and query resolution
- Be responsible for site communication and management
- Be a point of contact for in-house support services and vendors
- Communicate with internal project teams regarding study progress
- Participate in feasibility research
- Support regulatory team in preparing documents for study submissions
- Prepare and participate on audits and inspections
Qualifications
- At least Bachelor in Life Sciences or an equivalent combination of education, training & experience
- At least 2-3 years of independent on-site monitoring experience in China
, experience in all types of monitoring visits in Phase II and/or III
-Therapeutic area experience in Oncology is a plus
-Full working proficiency in English and Mandarin
-Proficiency in MS Office applications
-Ability to plan, multitask and work in a dynamic team environment
-Communication, collaboration, and problem-solving skills
-Ability to travel, up to 70% of time
- At least 2-3 years of independent on-site monitoring experience in China
, experience in all types of monitoring visits in Phase II and/or III
-Therapeutic area experience in Oncology is a plus
-Full working proficiency in English and Mandarin
-Proficiency in MS Office applications
-Ability to plan, multitask and work in a dynamic team environment
-Communication, collaboration, and problem-solving skills
-Ability to travel, up to 70% of time
工作地点
上海黄浦区腾飞元创大厦
公司信息
辟埃赛医药科技(上海)有限公司
不需要融资 · 20-99人 · 医药研发/生产外包（CXO）
已审核
公司介绍
PSI is a leading full-service global Contract Research Organization providing a wide range of clinical trial services to the pharmaceutical and biotechnology industry, mainly for the development of clinical drugs. PSI has 2,200+ employees and 40+ affiliates in Europe, North and South America, Asia Pacific and South Africa. PSI是一家提供全方位服务的全球临床试验项目承包商，为制药和生物技术行业提供广泛的临床试验服务，以帮助临床药物的开发。PSI在欧洲、北美和南美、亚太和南非拥有2200多名员工和40多家分支机构。
工商信息
企业名称 辟埃赛医药科技（上海）有限公司
企业类型 有限责任公司（外国法人独资）
法人代表 Angelika Ruf
经营状态 存续
成立时间 2019-02-28
注册资本 20万瑞士法郎
认证资质
营业执照信息
