- 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 subteams. This may include scribing meeting minutes to provide to project team leaders and project team members.
- Assist with or coordinate animalrelated study activities (i.e. clinical sampling test material administration and clinical observations). May include minimal animal handling.
Qualifications :
Minimum Qualifications:
- Bachelors 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 selfdirected and selfmotivated 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..
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 fulltime 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.
Remote Work :
No
Employment Type :
Fulltime