Job Description

The primary purpose of this position is to perform scientific and administrative support for study direction and study coordination teams. The Technical Study Coordinator II is responsible for assisting with the scientific and administrative tasks associated with coordination of routine and non-routine studies, in compliance with the appropriate company standards, GLP and regulatory guidelines in a timely, efficient manner. This includes initial development of proposal outlines, draft protocols, or other related information needed to assist in the costing process and review for standard inquiries at multiple company locations. General assistance to the Study Coordination team and Study Directors will be an essential part of the role and additional non study specific support may be given to key clients. Additional daily duties may include support of other functions within Safety Assessment. Responsibilities/Duties Indicate positions accountability _____ GLC/General Manager _____ Department Head/Function Lead _____ Manager of Managers _____ Manager __X__Individual Contributor B. People Responsibilities:
Indicate the number of:
___0__ Direct Reports ___0_ Indirect Reports This position functions in a matrix environment with no direct and indirect reports. C. Essential Job Duties: List of all essential job duties shown below is intended to describe the general nature of the job and is not intended to be an exhaustive list of all responsibilities, skills and duties.

• Gains knowledge of Safety Assessment service lines and uses resources to facilitate rapid proposal and draft protocol development. This consists of the initial development of proposal outlines and draft protocols to assist in the costing process for standard inquiries and the rapid scheduling of studies at all international sites.

• Gains knowledge of Safety Assessment services and studies and uses knowledge to

provide administrative support for toxicology studies, including pre-study and in-life tasks e.g. request form submission.

• Provide administrative backup support for Study Directors on day to day study-specific activities or tasks.

• Prepare shipping documentation including CITES application requests and any other associated shipping documentation.

• Assist with the further development of study protocols and amendments

• Understands protocols, standard operating procedures, Good Laboratory Practices, and other regulatory guidelines applicable to multiple sites.

• Uses project tracking systems.

• Is able to plan, prioritize, and manage a workload and the associated responsibilities.

• May initiate and submit costing and study related forms.

• Process purchase orders.

• May review data and identify deficiencies.

• Undertakes other administrative tasks and duties as assigned.

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