職位描述
Clinical Research Associate (CRA，臨床監察員) - Covance China
Are you a Clinical Research Associate who wants to work with one of leading global CROs in the industry? Covance is seeking CRAs with at least 1 year clinical monitoring experience NATIONWIDE, and has a variety of CRA needs in Phase II-IV and Phase I (Early Clinical Development) in multiple therapeutic areas such as oncology, cardiovascular, diabetes mellitus, endocrinology, etc. Whether you’re ready to make a move or just interested in learning more, apply TODAY and let’s talk together!
Covance China is committed to providing a clinical research career with purpose in a culture that values achievement. By joining our Clinical Trial Operations Team, you will work in a collaborative environment with the flexibility to pursue different clinical trials involving various compounds - giving you an excellent overview of best practices across the industry. Experience the global reach and therapeutic record of success from one of the few truly global drug development companies positioned to provide comprehensive clinical support from First-in-Human studies.
Responsibilities/Duties:
Clinical Research Associate performs site management, site administration and site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.
Responsibilities and duties include, but are not limited to the following:
? Take charge of all aspects of Site Management as prescribed in the project plans.
? Recruit potential investigators, prepare EC submissions, notify regulatory authorities, translate study-related documentation, and organize meetings and other tasks as instructed by supervisor.
? Negotiate study budgets with potential investigators and collaborate with the Covance legal department with statements of agreements as assigned.
? Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
? Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management.
? Assist with training, mentoring, and development of new employees, e.g. co-monitoring.
? Perform other duties as assigned by management.
Education/Qualifications:
? University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
Experience:
In lieu of the above requirement, candidates with three or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.
? Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines.
? Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
? CRA II positions require 2+ years of clinical research monitoring experience
? Senior CRA positions require 4+ years of clinical research monitoring experience. Alternatively candidates with 4+ years supervisory experience in a health care setting and 3+ years clinical research experience in the pharmaceutical or CRO industries (including monitoring) may also be considered.
Preferred:
One or more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred. More years of experience preferred if apply senior level CRA positions.
