Clinical Project Associate

RESPONSIBILITIES:

The VMRD Clinical Project Associate (VCPA) interfaces with R&D study teams to provide support in the

successful planning, development, implementation, conduct, documentation, and archive of a wide range of R&D studies. Serves as the point of contact with clinical project leads, clinicians, monitors, clinical research associates, and study sites, in the management of controlled documents; collaborates with various VMRD groups such as Document Management, Statistics, Data Management, and Regulatory Affairs to ensure the quality and timely filing of study documents for regulatory submissions; supports/assists the clinical study teams by identifying improvement opportunities to create efficient workflow processes; and seeks opportunities to outsource tasks that may be performed by services readily available at sites.

• Coordinate, with direction from clinical research associates, clinicians and/or project team leaders, the controlled document (e.g., study protocols, reports, amendments, & deviations) processes for research studies. These processes will involve the use of document management electronic systems for formatting and edits, version control, saving documents to and maintenance of controlled file share areas, coordination of document review, and circulation of documents for signatures before sending to the Document Management/Submission Publishing for regulatory submissions.
• Submit final versions of controlled documents for electronic signature and archiving, both electronic and hard copy, using document management systems as well as Animal Health Central Files.
• Adhere to internal standard operating procedures (SOPs) and/or other regulatory requirements.
• Provide expertise and participate in the management of controlled document templates for VMRD and assist with coordination and implementation of document authoring/review tools and VMRD Best Practices.  
• Support and assist project study teams by identifying opportunities for improving processes to create an efficient workflow process; seeks opportunities to outsource tasks that may be performed using services readily available at or near Zoetis facilities or study sites.
• Support project study team members with other study activities which may include, but are not limited to:
  • Prepare and/or track study data capture forms and other study materials (e.g., notebooks). Procure, via current purchasing methods, and/or ship study materials (e.g., small equipment, syringes, thermometers, etc.).
  • Prepare study files for regulatory submissions, including page counts and submission to Reprographics for scanning documents to PDF, tab creation, etc.
  • Prepare and organize study files for archival in Animal Health Central Files.
  • Prepare literature searches and procure journal articles and publications.
  • Participate in project study team meetings.
  • Maintain study metrics/information in various electronic systems and databases.
  • Assist with planning and preparation of off-site and Investigator meetings associated with clinical projects.
  • Assist with study data management including preparation for entry, review, verification, validation, and quality control processes.
  • Document communication records with study personnel.

WORK ENVIRONMENT

This position works primarily in an office environment and may, on a very rare occasion, require work in animal research facilities with exposure to a variety of animals, livestock and/or companion.  Work hours are typically 8:00 am to 5:00 pm, Monday through Friday, with some flexibility. 

QUALIFICATIONS

Educational Background:

Minimum:  High school diploma

Desirable:  Bachelor of Arts/Science degree in Business Administration, Life Sciences, Library Sciences.  

Work Experience/Skills:

Minimum:

• Minimum of 2 years administrative support experience in research.
• Expertise with multiple computer software applications including Outlook, Word, Excel, Power Point, Access, SharePoint, and Adobe Acrobat.
• Time management and organizational skills, ability to multi-task, attention to detail, flexibility, ability to work under pressure, and strong verbal/written communication skills, including listening.
• Effective with teamwork and a demonstrated ability to interact with multiple internal and external team members and other internal functional groups such as Reprographics, Regulatory Affairs, Quality Assurance and Document Management.
• Proactive, highly motivated, self-starter with a strong desire to understand and meet customer needs.
• Ability to quickly learn, follow and understand the purpose of existing business processes while continuously looking for ways to im