This job is archived
(Archived) Associate / Senior Associate - US Clinical Operations
Job Description
JOB TITLE:
Associate/Senior Associate
US Clinical Operations
Global Therapeutics
Veterinary Medicine Research & Development (VMRD)
Flexible Work Location
POSITION RESPONSIBILITIES:
The successful applicant embodies Zoetis’ Core Beliefs: Our Colleagues Make The Difference, Always Do The Right Thing, Customer Obsessed, Run It Like You Own It, and We Are One Zoetis.
Within US Clinical Operations, the candidate will be assigned to one or more Project Teams and will have the following duties and responsibilities:
As a member of the clinical team, assist with coordination of all study activities, including start up, investigator training, conduct, site monitoring and close out. These may include, but are not limited to:
- Assist in the preparation of study protocols, amendments, deviations, data capture forms, test article documentation and study reports
- 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
- Assist in data management processes including paper and electronic data capture, entry, review, tracking and verification utilizing electronic tools and centralized data management systems.
- Assist in preparation of study files for submission to regulatory agencies
- Provide clinical updates to project teams and sub-teams
- Assist with animal related study activities (i.e. clinical sampling, test material administration and clinical observations)
- Travel: approximately 10 – 40% on an annual basis. Variable, depending upon project status.
- Flexible Work Location
EDUCATION AND EXPERIENCE:
Educational Background:
Minimum: Bachelor's degree
Desirable: Master’s degree
Work Experience/Skills:
Minimum:
- Two years’ experience as a clinical study coordinator/monitor or in research in the pharmaceutical industry.
- Previous experience working with veterinary clinics and/or research facilities.
- Previous experience working in a Good Clinical Practice and/or Good Laboratory Practice environment.
- Ability to work both as a member of a team and independently in a self-directed and self-motivated manner.
- Excellent skills in the following competencies: 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).
Desirable:
- Experience and interest in the conduct of companion animal and/or livestock clinical field studies.
- Education and clinical experience in the field of veterinary technology and/or livestock production systems.
- Previous experience in research and/or product development in the animal health industry.
- Previous experience in the preparation of regulatory submissions.
- Competence with electronic data capture and remote communication tools.
- Experience in configuring studies in an electronic data capture platform