Job Description

• Preparation of study protocols, amendments, deviations, data capture forms, electronic data capture systems, test article documentation, and study reports.
• Execute and lead multiple CAE Bios studies simultaneously from coordinating animal and study supply shipments through report finalization, including interpretation of data, summaries and analysis, and study archiving.
• Collaborate with multiple internal partner groups to plan, coordinate, conduct, analyze, and report studies.
• Conduct training of Investigators and other study site personnel.
• Serve as the principal communication link between the Sponsor and study sites.
• Maintain study files in accordance with SOPs and regulatory requirements.
• Manage data management processes including paper and electronic data capture, overseeing data management plans, data import and review, tracking, and data verification/validation utilizing electronic tools and centralized data management systems.
• Provide clinical updates to project teams and sub-teams. This may include scribing meeting minutes to provide to project team leaders and project team members.
• Assist with or coordinate animal-related study activities (i.e., clinical sampling, test material administration, and clinical observations). May include minimal animal handling.

Qualifications

Minimum Qualifications:

• Bachelor's degree in relevant field
• Two years’ experience in companion animal medicine or livestock industry, a biological science area, a veterinary technician position, or research experience in an academic institution or the pharmaceutical industry.
• Ability to work both as a member of a team and independently in a self-directed and self-motivated manner.
• Skilled in the following competencies: organizing, planning, time management, quality, attention to detail, critical thinking and problem solving.
• Excellent written and oral communication skills.
• Competence with Microsoft Office Products (Outlook, Word, Excel, Teams) and remote communication tools (Zoom, etc.).
• Candidates within a commutable distance of Kalamazoo, MI are encouraged to apply

Preferred Qualifications:

• Experience and interest in working with companion animals, including horses.
• Previous experience in a research environment and/or prior experience in research/product development in the animal health industry.
• Understanding of Good Clinical Practice and/or Good Laboratory Practices.
• Experience conducting/monitoring studies to Good Clinical Practice and/or Good Laboratory Practice standards.
• Previous experience in the preparation of regulatory submissions.
• Competence with electronic data capture and/or eClinical software.

Additional Information

Position is full-time, Monday to Friday 8:00AM - 5:00PM. Candidates currently living within a commutable distance of Kalamazoo, MI are encouraged to apply.

What we offer:

· Comprehensive medical coverage, with dental and vision options

· Life and disability insurance

· Paid holidays and vacation.

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Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.