Clinical Research Regulatory Specialist A

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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.

Posted Job Title

Clinical Research Regulatory Specialist A

Job Profile Title

Clinical Research Regulatory Specialist A

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