Senior Associate I / II
Company | Zoetis |
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Location | Kalamazoo, MI, USA |
Salary | $Not Provided – $Not Provided |
Type | Full-Time |
Degrees | Bachelor’s, Master’s |
Experience Level | Junior, Mid Level |
Requirements
- Bachelor’s degree
- One-two years’ experience as a clinical study coordinator/monitor or in research in the animal health pharmaceutical industry
- Previous experience working with veterinary clinics and/or research facilities
- Understanding of Good Clinical Practice and/or Good Laboratory Practices
- Ability to work both as a member of a team and independently in a self-directed and self-motivated manner
- Excellent skills in organizing, planning, time management, quality, attention to detail
- Well-developed critical thinking skills with the ability to learn on the fly and problem solve
- Excellent interpersonal skills with very good written and oral communication skills
- Competence with Microsoft Office Products (Outlook, Word, Excel, OneNote, Teams)
Responsibilities
- Assist with, coordinate, or lead the coordination of all study activities, including start up, Investigator training, conduct, site monitoring and close out
- Assist in or prepare study protocols, amendments, deviations, data capture forms, electronic data capture systems, test article documentation and study reports
- Collaborate with multiple internal partner groups to plan, coordinate, conduct, analyze, and report studies
- Develop training materials and 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
- Assist with or coordinate the implementation and execution of data management processes including paper and electronic data capture, entry, review, tracking, and verification utilizing electronic tools and centralized data management systems
- Prepare study files for submission to regulatory agencies
- Lead multi-functional team(s) serving as a project team member or clinical sub team leader
- Coordinate animal related study activities (i.e. clinical sampling, test material administration and clinical observations)
- Travel: approximately 10 – 40% on an annual basis.
Preferred Qualifications
- Master’s degree
- Three-five years’ experience as a clinical study coordinator/monitor or in research in the animal health pharmaceutical industry
- Experience in the study design and execution of field based clinical studies
- Experience and interest in the conduct and leadership of companion animal clinical field studies
- Education and clinical experience in the field of veterinary technology
- 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, eClinical software or remote communication tools
- Experience in configuring studies in an electronic data capture platform/ eClinical software