Covance Clinical Research Associate I / II / Senior (Core Team) in Taiwan
Are you an exceptional Clinical Research Associate (CRA) based in Taiwan that has independent trial site monitoring experience and would like to experience working as a CRA at a global CRO?
Clinical Research Associates manage all aspects of study site monitoring according to Client SOP, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.
Study startup which include IRB/IEC submission, site selection, recruitment of potential investigators, notifications to regulatory authorities, translation of study-related documentation
Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
Study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
Site management as prescribed in the project plans
Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
Independently perform Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
May support in organization of meetings and other tasks as instructed by supervisor
Covance Taiwan is committed to providing Clinical Research Associates; the flexibility to work from home, the freedom to grow careers across all phases and areas of clinical trial operations as well as providing technology and processes that help to manage time and workload.
Covance is one of the world’s largest and most comprehensive drug development services companies, with more than 13,000 employees in 60 countries. We began operations Asia Pacific in 1988 and today have more than 1000 employees in 14 countries across the region. Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.
At Covance, you will join like-minded collaborative professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world.
-University degree with pharmacy, nursing or medical related preferred.
-Candidate with minimum 2 yrs or more relevant CRA experience in pharma or CRO
Thorough knowledge of ICH GCP and regulatory
Fluent in local language and English
2 or more years CR expereince in pharma or CRO
Excellent monitoring skill, site management skill, communication skills
Ability to work indepentant
Good planning and organization skill, computer skills
Ability to train junior staffs
Ability to resolve project related problems and priorities workload and work in a team
Work efficiently and effectively
Job Number 2018-18642
Job Category Clinical Operations
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.