Clinical Project Associate
Zoetis is a global animal health company dedicated to supporting customers and their businesses in ever better ways. Building on 60 years of experience, we deliver quality medicines and vaccines, complemented by diagnostic products and genetic tests and supported by a range of services. We are working every day to better understand and address the real-world challenges faced by those who raise and care for animals in ways they find truly relevant.Our name, Zoetis (z-EH-tis), has its root in zo, familiar in words such as zoo and zoology and derived from zoetic, meaning “pertaining to life.” It signals our company”s dedication to supporting the veterinarians and livestock producers everywhere who raise and care for the farm and companion animals on which we all depend.Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.JOB DESCRIPTION: Clinical Project Associate RESPONSIBILITIES:Incumbent will interface with all levels of the Project Study Team(s) and may exercise broad professional discretion in determining appropriate plans, priorities, processes and/or course of action required to achieve business goals, objectives, solutions and results. The incumbent Project Associate will have the following duties and responsibilities:
* Coordinate, with direction from clinical research associates, clinicians and/or project team leaders, the controlled document (e.g. study protocols, study reports, amendments, and deviations) processes for clinical 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 Shared Services Group for regulatory submissions. * Submit final versions of controlled documents for 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. * 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. * Prepare literature searches and procure journal articles and publications. * Participate in project study team meetings.
WORK ENVIRONMENTThis 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.
QUALIFICATIONSEducational Background:Minimum: High school diplomaDesirable: 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 improve upon these processes. * Ability to accurately scope out length and difficulty of tasks as well as ability to cope with change in order to ensure deadlines are met.Desirable: * 1 or more years of experience working in a clinical research organization, preferably within a veterinary R&D organization. * Knowledge of animal health clinical development and product license/approval processes. * Ability to design/work with complex MS Excel spreadsheets. * Experience with electronic data capture and clinical trial management systems * Knowledge of Good Clinical Practice (GCP) guidelines or other applicable regulatory regulations. Other Attributes Desirable:
* Strong customer focus and commitment to providing superior service to clinical study teams and ability to seek continuous feedback to ensure team needs are being met. * Action oriented, learns quickly and enjoys the challenge of finding new solutions. * Knowledgeable about how organizations work and skillful at getting things done both through formal channels and the informal network. * Perseverance – pursues everything with energy, drive and a need to finish. * Can be counted on to reach or exceed goals and steadfastly pushes self and others for results.