What are the responsibilities and job description for the Clinical Project Associate position at Zoetis?
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.
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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 improve upon these processes.
- Ability to accurately scope out length and difficulty of tasks as well as ability to cope with change 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.
Full time
Regular
Colleague
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Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.
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 or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at zoetiscolleagueservices@zoetis.com to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
