Clinical Researcher

JOB DESCRIPTION

Designs and executes companion animal biologics clinical studies in compliance with US CVB and / or EU EMA regulatory requirements.

Deliver pilot and pivotal, clinical and non-clinical studies resulting in product registrations. Provides expertise in the areas of companion animal study conduct to companion animal vaccines and infectious disease research and development phase projects.

POSITION RESPONSIBILITIES

Is responsible for supporting the overall conduct of clinical studies in support of Veterinary Medicine Research & Development (VMRD) companion animal research and development projects in biologics and infectious disease by contributing to investigator / site selection, protocol development / writing, monitoring, data analysis and interpretation, report, and technical section / regulatory dossier writing.

Able to organize and manage several projects and responsibilities at one time and prioritize own work. Hands on observations and expertise at study sites is required.

• Will be responsible for executing both laboratory in vivo clinical studies, as well as field studies in client-owned animals.
• Ensure that studies are conducted in compliance with applicable requirements, including Standard Operating Procedures (SOPs), corporate policies, and regulatory requirements and guidelines (e.

g., Good Clinical Practice and Good Laboratory Practice).

Collaborate with both Clinical and Project teams to define and track progress of study status, activities, timelines, and outcomes.

Identify when resource, time, and / or budget constraints occur and work with the Clinician, Project Manager, and Project Team Leader to identify solutions.

• Excellent written and verbal communication skills are required. Expertise in Microsoft Office applications, particularly Excel and Word will be utilized.
• Support development of colleagues within the clinical team.

EDUCATION AND EXPERIENCE

Minimum Experience :

BS or equivalent with 3 years or more experience in performing clinical studies in the animal health industry.

Preferred Experience :

• Advanced degree, MS or PhD with more than 5 years’ experience in the animal health industry.
• Demonstrated leadership and mentoring skills.
• Experience managing research programs involving companion animal species
• Experience working in teams supporting infectious disease research
• Experience working in research projects
• Experience working in biocontainment facilities
• Experience with more than one program of Electronic Data Capture
• Basic knowledge of USDA / EU regulatory path for animal vaccines

Full timeRegularColleague

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