Veeva Quality Assurance Specialist(Abramson Cancer Center) (Remote Eligible)

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Posted Job Title

Job Profile Title

Summary

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

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

Pay Range

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