长沙招聘

Responsibilities/Duties

? Provides administrative backup support for Study Director on day to day study specific activities or tasks.
? Initiates costing and scheduling requests with assistance.
? Participates in pre-initiation, prewriting, and other study-related meetings, as required.
? Takes and distributes Pre-initiation Meeting minutes.
? Draft protocols and revisions for Study Director review and approval.
? Verifies that project schedule sheets accurately reflect the requirements of the protocol.
? Coordinates study and reporting process on assigned studies.
? Becomes familiar with routine study procedures.
? Assists Study Director in monitoring critical phases of routine studies and reports any problems or deviations to the Study Director.
? Learns to compile data for draft summary reports for periodic study progress.
? Reviews data packages from the lab areas and identifies deficiencies.
? Writes and prepares routine study procedures, tables and graphs for the report.
? Incorporates contributing reports into the main toxicology report.
? Performs preliminary review of reports to assure completeness and accuracy prior to formal peer reviews.
? Addresses QA audits relating to reports, with oversight.
? Ensures that all client comments are addressed and documented in a timely manner and that revised or final reports are scheduled and mailed.
? Assists with hosting client visits.
? Performs report production tasks independently.
? Organizes and stores data packages from the lab areas.
? Prepares report tables and graphs.
? Uses the report template to prepare the report outline and verifies the report template against the protocol and amendments.
? Formats the report according to standard or client-specific requirements.
? Incorporates external contributor reports into report.
? Coordinates reporting processes on assigned studies (e.g., editing, formatting, and mailing of reports).
? Responsible for copying, binding, mailing, and archiving report and data during finalization.
? Assists the assigned anatomic and clinical pathologists in organizing and conducting aspects of the pathology portion of a study.
? Performs QC reviews on data/reports for anatomic and clinical pathology.
? Assures draft professional reports are in the standard format and make revisions to anatomic and clinical pathology reports when needed.
? Creates text tables/correlates data from Pristima/ToxReporting reports under the direction of the anatomic or clinical pathologist.
? Helps to host onsite pathology peer reviews. This includes organizing slides, data, generating tables and assisting with any requests. For offsite peer reviews, acts as the Covance contact point with responsibilities that include shipping, receiving and inventorying data/slides.
? Responsible for tracking internal report and other study deadlines for study director and pathologists and entering the dates into CMS. Prints CMS schedules and project sheets for study directors and pathologists.

Education/Qualifications
Bachelor's degree in a related science field Experience may be substituted for education.

Experience
Three years experience in toxicology.

Covance is one of the world’s largest and most comprehensive drug development services companies with more than 10,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.

Well come to our online job pool to dig out more opportunities at:
http://careers.covance.cn/