Clinical Research Regulatory Affairs Specialist (Philadelphia)

Clinical Research Regulatory Affairs Specialist

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.

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.

Job Profile Title

Clinical Research Regulatory Specialist B

Job Description Summary

Regulatory Affairs as a field is concerned with ensuring that clinical research is conducted in a safe and legally compliant manner. Regulatory Affairs staff are often the interface between PIs, product manufacturers (including internal at Penn), regulatory bodies (both internal and external) and research participants. Regulatory Affairs staff assist in obtaining and maintaining institutional and governmental approval for clinical trials. These trials often include FDA-regulated products, including drugs, medical devices, nutritional products and related materials. Regulatory Affairs Specialists must understand the applicable regulations and the roles and responsibilities of sponsors, vendors, clinical researchers, and government officials.

Job Responsibilities

• Participate in the coordination of unit / division clinical research, including but not limited to Phase I-IV clinical trials.
• Prepare and process all regulatory documentation / applications through the IRB and requisite ancillary review committees.
• Prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), and required governmental agencies, as well as, organize and maintain all regulatory affairs documentation / investigator site files (ISF) as required.
• Resolve regulatory and data queries as required, and participate in initiation, monitoring, audit and close-out visits related to the conduct of the research at the site.
• Participate in study team meetings, research team meetings, and ongoing protocol training / compliance meetings.
• Facilitate the development unit guidance / process documents including work tools, and development / maintenance of study specific case report forms, as well as, to provide direct regulatory / compliance guidance.
• Perform additional regulatory duties as assigned.

Qualifications

This position is contingent upon grant funding.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$62,000.00 - $63,600.00 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