Provides administrative and scientific support for toxicology studies including pre-study tasks (i.e. protocol development, costing, scheduling) monitoring the in-life progress of assigned studies, interacting with clients and preparing basic report components (i.e.drafting progress reports, writing report procedures, and reviewing results and conclusions in final reports for accuracy).
¨ 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 preinitiation, prewriting, and other study-related meetings, as required.
¨ Takes and distributes Preinitiation Meeting minutes.
¨ Drafts 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.
¨ Develops proficiency in specific software used in study conduct.
¨ Becomes familiar with routine study procedures.
¨ Assists Study Director in monitoring critical phases of routine studies and report any problems or deviations to the Study Director.
¨ Compiles data for draft summary reports for periodic study progress.
¨ Reviews data packages from the lab areas and identify deficiencies.
¨ Writes and prepare the 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.
¨ Performs 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
Bachelor's degree in a related science field Experience may be substituted for education.
Experience Two to three years experience in toxicology or a Master's Degree in a science field
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