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University of Pennsylvania Director of Clinical Trial Oversight in Philadelphia, Pennsylvania

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.

Posted Job Title

Director of Clinical Trial Oversight

Job Profile Title

Manager Research Project C

Job Description Summary

This position has been established for a Director of Clinical Trials Oversight within the Women’s Health Clinical Research Center in the Department of Obstetrics and Gynecology. It is expected that this position will provide operational and regulatory guidance and support for the conduct of clinical trials within the Department, working with a diverse group of investigators and support staff. The Director of Clinical Trials Oversight will support sponsor-investigator IND/IDEs held within the Department of Ob/Gyn, and will perform monitoring activities for internally sponsored clinical trials. The incumbent will also serve as an Executive Committee Member for the Women’s Health Clinical Research Center, with significant involvement in strategic planning and establishing Center initiatives.

Job Description

This position has been established for a Director of Clinical Trials Oversight within the Women’s Health Clinical Research Center in the Department of Obstetrics and Gynecology. It is expected that this position will provide operational and regulatory guidance and support for the conduct of clinical trials within the Department, working with a diverse group of investigators and support staff. The Director of Clinical Trials Oversight will support sponsor-investigator IND/IDEs held within the Department of Ob/Gyn, and will perform monitoring activities for internally sponsored clinical trials. The incumbent will also serve as an Executive Committee Member for the Women’s Health Clinical Research Center, with significant involvement in strategic planning and establishing Center initiatives.

Major Duties:

Provide operational and regulatory support in the conduct of clinical trials within the Department of Ob/Gyn. Assist sponsor-investigators in submission and management of IND and IDE applications. Serve as regulatory monitor for internally-sponsored clinical trials, both single- and multi-center. Create necessary study documents for the conduct of a clinical trial (protocol, consent form, manuals of operation, CRFs, etc). Create, maintain, and train staff on WHCRC SOPs. Provide training to investigators and staff on research regulations and Good Clinical Practice.

This position is contingent on funding.

Qualifications

Master's degree and 5-7 years of experience in clinical research, data management, medical industry/CRO or equivalent combination of education and experience is required. Position also requires an articulate individual with a strong background in project management and regulatory affairs. Must possess excellent oral and written communication skills as well as the ability to work independently and also as part of a team. Strong planning and organizational capabilities along with problem solving skills desired.

Must be able to work flexible hours. Must be able to communicate comfortably and effectively with regulatory authorities/sponsors/investigators. Requires strong attention to detail. Knowledge of GCP guidelines is a must.

Working ConditionsOffice, library, computer roomPhysical EffortTypically sitting at a desk or table; Occasional lifting 25 lb. or less; Typically standing or walking

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$72,837.00 - $138,391.00

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

The University of Pennsylvania's special character is reflected in the diversity of the Penn community. We seek talented faculty and staff who will constitute a vibrant community that draws on the strength that comes with a substantive institutional commitment to diversity along dimensions of race, ethnicity, gender, sexual orientation, age, religion, disability, veteran status, interests, perspectives, and socioeconomic status. Grounded in equal opportunity, nondiscrimination, and affirmative action, Penn's robust commitment to diversity is fundamental to the University's mission of advancing knowledge, educating leaders for all sectors of society, and public service. The University of Pennsylvania prohibits unlawful discrimination based on 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.

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