Associate Scientist II, Toxicology Study Coordinator

Employer
AbbVie
Location
Lake County, IL, US
Posted
Oct 21, 2019
Ref
1906764
Required Education
Bachelors Degree
Position Type
Full time
The Associate Scientist II, Toxicology Study Coordinator will be a part of the Preclinical Safety function and report to a manager in Toxicology. The purpose of this role is to aide in the planning, conduct, and reporting of non-GLP and GLP toxicology studies, acting to support various Study Directors and interface with AbbVie's regulatory infrastructure.

MAJOR RESPONSIBILITIES:

  • Draft study plans, amendments, and report components
  • Assist in the technical conduct of nonclinical studies including account 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 Study Directors, acting as a designee for some tasks
  • Study support may include data review, preparing report data tables, drafting report sessions, 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


Required Qualifications:

  • Bachelor's degree and three years industry experience OR Masters degree and no experience.
  • Computer skills appropriate for job task
  • Aptitude for managing multiple projects in a regulated environment
  • Excellent oral and written communication skills
  • Proven flexibility to deal with changing timelines, shifting work priorities, and evolving regulatory/industry requirements.


Preferred Qualifications:
  • Expertise in Good Laboratory Practices
  • Previous experience in the conduct and/or reporting of nonclinical studies