Clinical Research Regulatory Specialist A jobs in United States
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University of Pennsylvania · 1 month ago

Clinical Research Regulatory Specialist A

positionHUP
timeFull-time
remoteOnsite
seniorityEntry Level
money$23.06/hr - $25/hr
date2+ years exp

The University of Pennsylvania is a world-renowned leader in education, research, and innovation. The Clinical Research Regulatory Specialist A will support regulatory compliance and coordination of early phase clinical trials at the Penn Frontotemporal Degeneration Center.

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Responsibilities

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
Assisting with all aspects of complex clinical trial visits, including recruitment/enrollment, visit scheduling and patient facing study activities
Working collaboratively with study coordinators, project managers, and investigators in the Penn FTD Center
Participating in study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings
Maintaining University of Pennsylvania, FDA, and GCP standards and guidelines

Qualification

Regulatory complianceClinical trialsIRB submissionData entryTeam collaboration

Required

High School diploma and 2 years of experience or an equivalent combination of education and experience required

Preferred

Bachelor's degree preferred

Benefits

Health, Life, and Flexible Spending Accounts
Tuition
Retirement
Time Away from Work
Long-Term Care Insurance
Wellness and Work-life Resources
Professional and Personal Development
University Resources
Discounts and Special Services
Flexible Work Hours
Penn Home Ownership Services
Adoption Assistance

Company

University of Pennsylvania

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The University of Pennsylvania is an American private Ivy League Research University that excels in producing future leaders.
dateFounded in 1740
location
Philadelphia, Pennsylvania, USA
people-size10001+ employees
web-link
http://www.upenn.edu

Funding

Current Stage
Late Stage
Total Funding
$81.46M
Key Investors
National Science FoundationUS Department of EnergyParent Project Muscular Dystrophy
2024-08-28Grant
2023-06-26Grant· $18M
2022-09-15Grant· $55M

Leadership Team

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Mark Dingfield
Executive Vice President
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Angela Duckworth
Secondary Appointment at the Graduate School of Education
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Recent News

The Philadelphia Inquirer
Penn calls federal commission’s request for personal employee information ‘unconstitutional,’ ‘disconcerting’ and ‘unnecessary’
2026-01-22
PR Newswire
Beckman Foundation Announces 2026 Beckman Scholars Program Awardees
2026-01-16
The Philadelphia Inquirer
Jewish students and faculty at Penn ask that their names not be turned over in federal antisemitism investigation
2026-01-16
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