Job Description

The position of Associate Scientist, Toxicology Study Coordinator is in the Preclinical Safety group and will report to a manager in Toxicology.  The Associate Toxicologist aides in the planning, conduct and reporting of non-GLP and GLP toxicology studies, acting to support the Study Director and regulatory infrastructure.  

MAJOR RESPONSIBILITIES:

Draft study plans, amendments, and report components

Assist in the technical conduct of nonclinical studies including protocol set-up in electronic data capture system and scheduling of study events

Perform data review periodically through study conduct and at study completion

Facilitate communications among study personnel

Coordinate the archival of study data and specimens

Support GLP infrastructure through quality control responsibilities and active participation in process improvement activities

ACCOUNTABILITY / SCOPE:

Responsible for key tasks in the set-up and conduct of nonclinical studies

Support the Study Director, acting as a designee for some tasks

Study support may include data review, preparing report data tables, drafting report sections, coordinating study data archiving, and other tasks as needed

Compile input from subject matter experts and incorporate into study plans

Facilitate study scheduling and resource allocation

Assist in driving assigned deliverables to timely completion

Maintain training to meet compliance standards