Veeva Quality Assurance Specialist(Abramson Cancer Center) (Remote Eligible)
University Overview
The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America’s Best Large Employers in 2023.
Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.
The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.
COVID-19 vaccination or a University authorized exemption is a requirement for all positions at the University of Pennsylvania. For more information about Penn’s vaccine requirements, visit the Penn COVID-19 Response website for the latest information.
Posted Job Title
Veeva Quality Assurance Specialist(Abramson Cancer Center) (Remote Eligible)
Job Profile Title
Regulatory Affairs Specialist
Job Description Summary
The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The ACC Clinical Research Unit (CRU) is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. The ACC CRU is currently comprised of 14 Research Teams that support disease/discipline specific cancer programs within the ACC.
Job Description
The CRU Regulatory Affairs Office seeks a full-time Regulatory Affairs Veeva Quality Assurance Specialist to participate in the review and migration of Phase I-V clinical trial investigator site files to the Veeva SiteVault platform. Reporting to the Veeva Quality Assurance Lead, the Veeva Quality Assurance Specialist will review, itemize and migrate all regulatory documentation from the current document management system to the SiteVault platform.
The primary tasks associated with this position include: creation of a document inventory, quality assurance review of each inventory, mapping of existing data to unique Veeva data fields, assignment of metadata for new data fields, migration of the created document inventory to the SiteVault platform (including person, organization, product and study profiles) via bulk document transfer— for all trials in the existing ACC-CRU portfolio.
Qualifications:
Bachelor’s degree (preferably in a life science or human subject protection field) required and 3-5 years research experience required; at least 2 years regulatory experience preferred. Experience conducting high risk biomedical research and/or oncology regulatory research experience preferred. The successful candidate must have effective problem solving and critical thinking abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently.
Candidates must desire to work in a fast-paced environment with competing priorities. Candidates should welcome constructive criticism, be open to learning new approaches, and committed to continued career/professional growth. Candidates must have a high level of general computing ability. Intermediate/expert level of function in all of the Microsoft Office applications, as well as, applications for team interconnectivity such as Slack, Microsoft Teams, Zoom, Webex, BlueJeans etc. Knowledge and/or experience working with web-based e-regulatory document management systems such as eFlorence, Veeva Systems products, etc. is a plus.
Working Conditions:
This position is intended to be largely remote. Candidate must agree to use a remote workspace that is conducive to working, free of hazards and other dangers to people and equipment. Abramson Cancer Center, Clinical Research Unit strongly recommends the candidate set up a separate area. Equipment should be placed where it is adequately supported. The candidate remains obligated to comply with all University rules, policies, practices and instructions that would apply if the candidate were working on the premises of the University. The candidate agrees to ensure arrangements are made for dependent care and confirms non-work related interests will not compete with work requirements during the designated regular work hours. The candidate will be responsible for determining any tax implications of maintaining the remote workspace. The candidate will be responsible for complying with any and all local township codes, rules, regulations, and zoning ordinances which could affect the ability to use the designated remote workspace.
POSITION IS CONTINGENT UPON CONTINUED FUNDING
Job Location – City, State
Philadelphia, Pennsylvania
Remote Eligible – This position is eligible for a fully remote schedule with all work performed remotely. (Note: Only salaried (i.e., exempt), non-temporary positions are eligible for remote work outside the tri-state area (Pennsylvania, New Jersey and Delaware.)
Department / School
Perelman School of Medicine
Pay Range
$51,824.00 – $78,096.00
Salary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile.
Affirmative Action Statement
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.
Special Requirements
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
University Benefits
To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay
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