Clinical Research Coordinator C

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 Coordinator C

Job Profile Title

Clinical Research Coordinator C

Job Description Summary

The Division of Cardiology at Pennsylvania Hospital seeks a full-time Clinical Research Coordinator to organize, coordinate and implement complex studies involving a wide variety of investigational products/devices and various sponsors. S/he will be responsible for all aspects of clinical trial coordinator. The coordinator will assist physicians/investigators with initiating study procedures for new industry-sponsored and investigator-initiated clinical trials. S/he will organize and assist in the preparation of documents and systems needed for initiation, enrollment, monitoring, internal and external auditing, and study close-out visits for complex Phase I-IV clinical trials. They will interface with regulatory authorities, sponsors, CROs, and cooperative groups as directed by the supervisor.

He/she will be responsible for submission of studies to Institutional Review Board (IRB), ongoing maintenance of regulatory documentation including additional applicable reviewing entities per each entity's required timeline, and maintenance of the essential documents binder/TMF. S/he will assist in review of new trials, assist with development of site specific documents (CRFs, SOPs, databases development), help investigators identify the challenges and opportunities, problem-solve the challenges and implement a plan of action to mitigate potential barriers.

He/she will also be responsible for the screening of patients, provision and discussion of informed consent documents, subject enrollment, collection and storage of biological samples and related study documents, implementation and performance of study related procedures and assessments, collection of clinical and research data with proper source documentation and CRF completion, perform accurate data entry to study specified databases, and conduct accountability of investigational product devices. The coordinator will execute and ensure adherence to the protocol and Good Clinical Practice, while taking an active role in preparation of trial audits and inspection. S/he will provide regular updates to the investigators, research team, and other stakeholders as needed. S/he may assist in analyzing clinical data to determine response and clinical outcomes; assist with literature reviews; contribute to the preparation of study abstracts, posters, manuscripts, and grant applications. S/he may act as a mentor to coordinators who have joined the unit with less research experience.