"Clinical Research Regulatory Specialist A"

Clinical Research Regulatory Specialist A

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.

Job Description Summary

This position is based in the Penn Frontotemporal Degeneration Center, part of the Department of Neurology of the University of Pennsylvania's Perelman School of Medicine. The purpose of this position is to provide support in the regulatory compliance and coordination of early phase clinical trials through the University of Pennsylvania Frontotemporal Degeneration Center.

Job Description

The Clinical Research Regulatory Specialist A will perform a variety of research and administrative tasks to help support the conduct of industry sponsored clinical research/trial protocols in the Penn FTD Center, specifically early phase, complex clinical trials. Responsibilities include: preparing for study visits, including labeling study kits and preparing visit packets; maintaining study supplies, including ordering study kits; assisting with the collection, handling, and processing of biofluid samples; maintaining investigator site files; ensuring that delegation of authority logs and study team training logs are accurate and up to date; organizing and maintaining staff credentials needed for regulatory compliance; assisting with the preparation and submission of IRB documents for clinical trials; helping to prepare for study monitoring visits; completing data entry and query resolution; and assisting with all aspects of complex clinical trial visits, including recruitment/enrollment, visit scheduling and patient facing study activities.

The Clinical Research Regulatory Specialist A will work collaboratively with study coordinators, project managers, and investigators in the Penn FTD Center; Participates in study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings; Maintains University of Pennsylvania, FDA, and GCP standards and guidelines.

The Clinical Research Regulatory Specialist A will function as part of a multidisciplinary team and will report to the Penn FTD Center Regulatory Project Manager.

Qualifications

• High School diploma and 2 years of experience or an equivalent combination of education and experience required. Bachelor's degree preferred.

Position is contingent upon continued funding.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$23.06 - $25.00 Hourly Rate

To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/HUP/Clinical-Research-Regulatory-Specialist-A_JR00115168-1