職位描述
CRA新藥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
工作地點
上海黃浦區(qū)騰飛元創(chuàng)大廈
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職位發(fā)布者
沙凝/人事經理
三日內活躍立即溝通
辟埃賽醫(yī)藥科技(上海)有限公司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務的全球臨床試驗項目承包商，為制藥和生物技術行業(yè)提供廣泛的臨床試驗服務，以幫助臨床藥物的開發(fā)。PSI在歐洲、北美和南美、亞太和南非擁有2200多名員工和40多家分支機構。
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