Regulatory Administrative Coordinator

Location
Pennsylvania United States
Posted
19 Nov 2018
End of advertisement period
19 Jan 2019
Ref
40-30462
Contract Type
Permanent
Hours
Full Time

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.

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.

School/Center Overview

The Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education. http://www.med.upenn.edu/

Duties

The Regulatory Affairs Administrative Coordinator provides high-level administrative support for the Abramson Cancer Center (ACC) Clinical Research Unit (CRU). The ACC-CRU supports the day to day activities of over 150 active interventional clinical trials, across 13 research teams, involving more than 100 staff. This position directly reports to the CRU Regulatory Affairs Manager. Responsibilities include day to day oversight and coordinating of the credentialing information for CRU associated faculty, research nurses, research coordinators, and ancillary support staff inclusive of both internal credentials such as CITI/GCP and protocol specific training, as well as, external NCI/CTEP registrations, practice licensures and person profiles; completion of regulatory quality assurance documentation pertaining to the ongoing approval for research activities; review and organization of ongoing trial documentation in preparation for internal regulatory audits/inspections; reporting out expected deadlines for trial annual reports/continuing renewals; and acting as the primary on-site liaison with external entities including pharmaceutical companies, contract research organizations (CROs), the NCI Cooperative/Clinical Network Groups in the facilitation of planned interim study monitoring activities. Continued responsibilities include implementing, with autonomy, administrative processes and projects that support the Regulatory Office including maintenance of workspace resources and carrying out special projects in support of the unit’s mission; composing, typing, editing and/or reviewing correspondence and other written materials; assisting faculty with inquiries and unit standard procedures.

A High School diploma or 5 years of experience or an equivalent combination of education and experience required. The position requires someone with desire to take initiative, excellent organizational, problem-solving skills, interpersonal skills, and the ability to thrive in a fast paced environment with competing deadlines and priorities, whether working autonomously or as part of a team. The Administrative Coordinator must be able to exercise sound judgment and discretion in working with confidential and sensitive matters. Strong oral and written communication skills, demonstrated intermediate to advanced level PC skills including all facets of Microsoft Office, and the ability to effectively utilize the Internet are required.

Qualifications

A High School diploma and 5 years of experience or an equivalent combination of education and experience required. The position requires someone with the desire to take initiative, excellent organizational, problem-solving skills, interpersonal skills, and the ability to thrive in a fast paced environment with competing deadlines and priorities, whether working autonomously or as part of a team. The Administrative Coordinator must be able to exercise sound judgment and discretion in working with confidential and sensitive matters. Strong oral and written communication skills, demonstrated intermediate to advanced level PC skills including all facets of Microsoft Office, and the ability to effectively utilize the Internet are required.

Affirmative Action Statement

Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.

Special Requirements  

Quick Link

http://jobs.hr.upenn.edu/postings/41664