Senior Research Associate - Toxicology

Job Description

Toxicology Study Coordinator

100% onsite - Carlsbad, CA

Our client is seeking a highly organized and detail-oriented professional to join a Toxicology team as a Study Coordinator. In this cross-functional role, you will serve as the primary liaison between the client, contract research organizations (CROs), and various internal teams.

The Study Coordinator role is a fast-paced, cross-functional, vital role in the smooth execution of nonclinical study conduct.

Study coordination and operational responsibilities include:

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• Facilitation of study contracts (SOWs), protocols, reports, etc.
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• Test article and formulation requests, review of study protocols, reports, amendments, etc
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• Track and maintain study specific milestones using in-house database in support of quarterly finance updates
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• Coordinate sample shipments, receipt and transfer of sensitive study samples; maintain Chain of Custody
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• Prepare, review and distribute data templates
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• Maintain and update study outlines templates
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• General assistance to Scientists will be an essential part of the role and additional non study specific support may be required across departments
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• QC reports, data, data tables, presentations, documents for regulatory submissions (eg IND, IB, NDA, etc) using advanced functions of MS Word, Excel and e-sub compliance software, as appropriate.
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• Plan, prioritize, and manage a diverse workload with associated responsibilities
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• Schedule and participates in department and study-related meetings, as required, prepare meeting minutes.
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• General operational support including document processing (e.g., ELN, study tracker management, etc.), maintaining file systems for accuracy and completeness, invoice review and approval.
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Experience / Background required:

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• A Bachelor’s degree in biology or a related science field is required along with a minimum of 5 years relevant experience. Experience in nonclinical study conduct is required.
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• Strong candidates must be highly proficient with Microsoft Office applications, possess excellent organizational, multitasking, and communication skills. The ability to work both independently and collaboratively is essential. The ideal candidate will also demonstrate flexibility and adaptability in a dynamic, team-oriented environment.
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