Clinical Research, Parasitology

🌍 Remote, USA 🎯 Full-time 🕐 Posted Recently

Job Description

Participate on project teams to develop and license veterinary parasiticides
Coordinate or lead the coordination of all study activities, including study start up, Investigator training, conduct, site monitoring and close out
Prepare study protocols, amendments, deviations, data capture forms, electronic data capture systems, test article documentation and study reports for submission to regulatory agencies
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
Coordinate animal related study activities (i.e. clinical sampling, test material administration and clinical observations)
Serve as the principal communication link between the Sponsor and study sites
Maintain study files in accordance with SOPs and regulatory requirements
Implement and execute 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, author study reports and review technical section summaries for submission to regulatory agencies (FDA, EMA, EPA)
Lead multi-functional team(s) serving as a project team member or clinical team lead
Contribute to, review and/or author manuscripts for journal publication
Present results, as needed, both internally and to external scientific audiences
Travel: approximately 10 – 40% on an annual basis

Bachelor's degree minimum
Five years’ experience as a clinical study coordinator/monitor or in research/product development in the animal health pharmaceutical industry
Experience in the study design and execution of parasitology laboratory clinical studies
Familiarity with parasitology study designs and models as well as regulatory guidance/expectations for the conduct and execution of parasitology studies
Previous experience with preparation of regulatory submissions for FDA, EPA and/or EMA for product registration
Previous experience working with veterinary clinics and/or research facilities
Experience with 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)
Experience in configuring studies in an electronic data capture platform/ eClinical software.