Clinical Project Associate at Zoetis

Kalamazoo, Michigan, United States

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Animal Health, Veterinary, BiotechnologyIndustries

Requirements

High school diploma
Minimum of 2 years administrative support experience in research
Expertise with multiple computer software applications including Outlook, Word, Excel, PowerPoint, Access, SharePoint, and Adobe Acrobat
Preferred Qualifications
Bachelor of Arts/Science degree in Business Administration, Life Sciences, or Library Sciences
1 or more years of experience working in a clinical research organization

Responsibilities

Interface with R&D study teams to support planning, development, implementation, conduct, documentation, and archiving of R&D studies
Serve as point of contact with clinical project leads, clinicians, monitors, clinical research associates, and study sites for management of controlled documents
Collaborate with groups such as Document Management, Statistics, Data Management, and Regulatory Affairs to ensure quality and timely filing of study documents for regulatory submissions
Support clinical study teams by identifying improvement opportunities for efficient workflow processes and seeking opportunities to outsource tasks available at sites
Coordinate controlled document processes (e.g., study protocols, reports, amendments, deviations) with direction from clinical research associates, clinicians, and project team leaders, including use of document management electronic systems for formatting, edits, version control, review, signatures, and submission
Submit final versions of controlled documents for electronic signature and archiving (electronic and hard copy) using document management systems and Animal Health Central Files
Adhere to internal standard operating procedures (SOPs) and regulatory requirements
Provide expertise and participate in management of controlled document templates for VMRD; assist with coordination and implementation of document authoring/review tools and VMRD Best Practices
Support project study teams with activities including preparing/tracking study data capture forms and materials, procuring/shipping study materials, preparing study files for regulatory submissions (e.g., page counts, scanning to PDF, tab creation), preparing/organizing study files for archival, literature searches, procuring articles/publications, participating in team meetings, maintaining study metrics in electronic systems/databases, assisting with planning/preparation of off-site/Investigator meetings, assisting with study data management (entry, review, verification, validation, quality control), and documenting communication records with study personnel

Skills

Key technologies and capabilities for this role

Document ManagementClinical ResearchSOPsRegulatory SubmissionsElectronic Signature SystemsVersion ControlStudy ProtocolsProject CoordinationR&D StudiesWorkflow Optimization

Questions & Answers

Common questions about this position

Is this a full-time position?

Yes, this is a full-time role.

What is the location or remote work policy for this role?

This information is not specified in the job description.

What skills or experience are required for the Clinical Project Associate role?

The role requires expertise in managing controlled documents using electronic systems, adherence to SOPs and regulatory requirements, coordination with clinical teams, and familiarity with document management, version control, and regulatory submission processes.

What is the company culture or work environment like at Zoetis for this position?

This information is not specified in the job description.

What makes a strong candidate for the VMRD Clinical Project Associate position?

Strong candidates will have experience interfacing with R&D study teams, managing controlled documents for clinical studies, using document management systems, and supporting process improvements and regulatory submissions.