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Posted Job TitleVeeva Quality Assurance Specialist (Abramson Cancer Center)Job Profile TitleClinical Research Regulatory Specialist BJob Description SummaryThe 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 12 Research Teams that support disease/discipline specific cancer programs within the ACC. Contingent upon funding.Job DescriptionJob Responsibilities
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. Contingent upon funding.
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.
Department / SchoolPerelman School of MedicinePay Range$51,824.00 - $63,600.00 Annual RateSalary 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
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