Clinical Research Regulatory Specialist B

upenn; Upper Paxton Township (PA); On-site; USD 85,000 - 105,000; Full time

Job summary

The Penn Neurogenetics Therapy Center (PNTC) is seeking a Clinical Research Regulatory Specialist B to support trial startup and ongoing regulatory activities across its portfolio, ensuring compliance with institutional and federal regulations and ICH-GCP guidelines.

You will coordinate regulatory submissions, manage essential trial documentation, and collaborate with investigators, sponsors, CROs, and internal offices to enable timely trial activations and continuous regulatory support

Responsibilities

• Coordinate clinical trial startup from feasibility through site activation, tracking regulatory submissions and essential study documentation.
• Prepare and process regulatory submissions to IRB and ancillary committees; collect and submit essential regulatory documentation to sponsors, CROs, and applicable entities.
• Provide ongoing regulatory support for active trials, including protocol amendments, continuing reviews, reportable events, and updates to study documents.
• Maintain complete, inspection-ready regulatory documentation and investigator site files throughout the study lifecycle, in line with regulatory requirements.
• Resolve regulatory queries and support study oversight activities, including site initiation, monitoring, audit, inspection, and close-out.
• Participate in study team meetings, protocol/regulatory training, and contribute to process improvements in regulatory and startup workflows.

Job description

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.

Posted Job Title

Clinical Research Regulatory Specialist B

Job Profile Title

Clinical Research Regulatory Specialist B

Job Description Summary

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 trial startup and ongoing regulatory activities across the Center's portfolio of clinical trials while following applicable institutional and federal regulations as well as ICH-GCP guidelines. The CRRS B will function as part of a multidisciplinary team and will report to the PNTC Director of Operations.

Job Description

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 ancillary submissions, essential study documentation, and other startup requirements to support efficient and timely study activation. Following activation, the CRRS B will collaborate with study teams to provide ongoing regulatory support, including protocol amendments, continuing reviews, reportable events, regulatory documentation, maintenance of complete and inspection-ready study files, and coordination of monitoring visits and audits.

• 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 activation requirements across regulatory, operational, budget, and contract workflows.
• Prepare, coordinate, and process regulatory submissions to the IRB 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, reportable events, personnel and study document updates, and other required regulatory submissions and documentation.
• Maintain complete, accurate, current, and inspection-ready regulatory documentation and investigator site files (ISFs) throughout the study lifecycle in accordance with institutional, sponsor, and applicable regulatory requirements.
• Resolve regulatory queries and support study oversight activities, including site initiation, monitoring, audit, inspection, and close-out activities, in collaboration with investigators and study teams.
• Participate in study team meetings, protocol and regulatory training, and compliance activities, and contribute to the development and continuous improvement of regulatory and clinical trial startup processes, guidance documents, t