Clinical Research Regulatory Specialist B

Clinical Research Regulatory Specialist B 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 Forbeswho 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 forwork 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.

Clinical Research Regulatory Specialist B

Clinical Research Regulatory Specialist B

The Penn Neurogenetics Therapy Center (PNTC) supports a diverse group of neurogenetics investigators and clinical research professionals conducting investigator-initiated clinical research and complex, industry-sponsored, first-in-human trials of gene therapies for neurological diseases. The PNTC is seeking a Clinical Research Regulatory Specialist B (CRRS

B) to support clinical trialstartup and ongoing regulatory activities across the Center'sport folio of clinical trials while following applicableinstitutional and federal regulations as well as ICH-GCPguidelines. The CRRS B will function as part of a multidisciplinary team and will report to the PNTC Director of Operations.

The CRRS B will play a key role in coordinating trial start-up activities from feasibility assessment through site activation,working closely with PNTC Project and Business Managers,investigators, study teams, institutional offices, sponsors, and contract research organizations (CROs). Responsibilities will include coordinating and tracking regulatory and ancillarysubmissions, essential study documentation, and other startuprequirements to support efficient and timely study activation.

Following activation, the CRRS B will collaborate with study teamsto provide ongoing regulatory support, including protocolamendments, continuing reviews, reportable events, regulatory documentation, maintenance of complete and inspection-ready studyfiles, and coordination of monitoring visits and audits.

The ideal candidate will be highly motivated, organized, anddetail-oriented, with a proactive and collaborative approach andthe ability to plan and manage multiple priorities and deadlines ina fast-paced clinical research environment. Prior experience with regulatory/ethics boards/ancillary submissions and reviews,industry-sponsored early-phase clinical trials, and/or gene therapyresearch is strongly preferred.

• Coordinate clinical trial startup from feasibility assessment through site activation, working collaboratively with PNTC Project and Business Managers and other stakeholders to track regulatory and ancillary submissions, essential study documentation,timelines, dependencies, outstanding items, and activationrequirements across regulatory, operational, budget, and contractworkflows.
• Prepare, coordinate, and process regulatory submissions to theIRB and required ancillary review committees, and prepare, collect,and submit essential regulatory documentation required by sponsors,CROs, and other applicable entities.
• Provide ongoing regulatory support for active clinical trials,including protocol amendments, continuing reviews, reportableevents, personnel and study document updates, and other requiredregulatory submissions and documentation.
• Maintain complete, accurate, current, and inspection-readyregulatory documentation and investigator site files (ISFs) throughout the study lifecycle in accordance with institutional,sponsor, and…