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 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.

The ideal candidate will be highly motivated, organized, and detail-oriented, with a proactive and collaborative approach and the ability to plan and manage multiple priorities and deadlines in a fast-paced clinical research environment. Prior experience with regulatory/ethics boards/ancillary submissions and reviews, industry-sponsored early-phase clinical trials, and/or gene therapy research 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 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, templates, trackers, and other work tools.
• •Perform additional duties as assigned.

The position is hybrid eligible and contingent on continued funding.

The job pay range encompasses the full range of employees from new hires to the salaries of Penn employees with many years of experience and seniority. It is not a precise indicator of the new salaries of new hires when working at the top end.

Qualifications

Bachelor's degree and 3-5 years of research experience or equivalent combination of education and experience is required . At least 1 year of regulatory experience preferred. Associated research credentialing (RAC, CCRP, CIP, etc.) preferred.

Preferred: Must be organized and able to prioritize; effective communication and writing skills; strong time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently. At least 1 year of regulatory experience preferred. Associated research credentialing (RAC, CCRP, CIP, etc.) preferred.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$63,085.00 - $70,119.00 Annual Rate Salary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job’s level. Internal organization and peer data at Penn are also considered.

Equal Opportunity Statement

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics) , citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law .

• Special Requirements
• Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

University Benefits

Health, Life, and Flexible Spending Accounts : Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family’s health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.

Tuition : Take advantage of Penn's exceptional tuition benefits . You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.

Retirement: Penn offers generous retirement plans to help you save for your future. Penn’s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.

Time Away from Work: Pen