Clinical Research Regulatory Specialist B (Abramson Cancer Center)

Clinical Research Regulatory Specialist B (Abramson Cancer Center)

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 (Abramson Cancer Center)

Job Profile Title

Clinical Research Regulatory Specialist B

Job Description Summary

The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The ACC One Cancer Clinical Research (OCCR) is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. Contingent upon funding.

Job Description

Job Responsibilities

• The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The ACC One Cancer Clinical Research (OCCR) is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. Contingent upon funding.

The ACC OCCR Regulatory Affairs Office seeks a full-time Regulatory Affairs Specialist-CC to participate in the coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager, the Regulatory Affairs Specialist-CC will, with minimal supervision , prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events. He / she will, with minimal supervision , prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), the NCI and the FDA, as well as, organize and maintain all regulatory affairs documentation / files as required. The Regulatory Affairs Specialist-CC is expected to resolve regulatory and data queries as required, and participate in initiation, monitoring, audit and close-out visits. He / she will participate in study team meetings, research team meetings, and ongoing protocol training / compliance meetings. The Regulatory Affairs Specialist-CC is expected to facilitate the development and submission of FDA IND applications and annual reports, and development / maintenance of study specific case report forms and source document tools, as well as, to provide direct regulatory / compliance guidance and facilitate investigator initiated trials and investigator-initiated multi-site trials. Additional duties relevant to regulatory affairs as assigned.

Qualifications

Bachelor's degree (preferably in a life science or human subject protection field) required and 3-5 years research experience or equivalent combination of education and experience is required; at least 1 years regulatory experience preferred. Experience conducting high risk biomedical research and / or oncology regulatory research experience preferred. Associated research credentialing (CCRP, CIP, etc.) preferred.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$62,000.00 - $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

To learn more, please visit : https : / / www.hr.upenn.edu / PennHR / benefits-pay

Equal Employment 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.

To apply, visit https : / / wd1.myworkdaysite.com / en-US / recruiting / upenn / careers-at-penn / job / Perelman-Center-for-Adv-Medicine / Clinical-Research-Regulatory-Specialist-B Abramson-Cancer-Center-_JR00093451-1

Copyright ©2025 Jobelephant.com Inc. All rights reserved.

Posted by the FREE value-added recruitment advertising agency

jeid-1ee106c0709ca64ea5fde246f7b29554