Clinical Research Coordinator A/b - Frankfurt Am Main, Deutschland - University of Pennsylvania

University of Pennsylvania

Geprüftes Unternehmen

Frankfurt Am Main, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

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 Employers By State in 2021.

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.

COVID-19 vaccination is a requirement for all positions at the University of Pennsylvania. New hires are expected to be fully vaccinated before beginning work at the University. For more information about Penn's vaccine requirements, visit the

Penn COVID-19 Response website

for the latest information.

Posted Job Title

Clinical Research Coordinator A/B (Department of Surgery)

Job Profile Title

Clinical Research Coordinator A

Job Description Summary

The CRC A/B will manage and support regulatory and operational aspects of an investigator-initiated drug trial, as well as other device and/or drug trials and research studies as assigned.

Job Description:

The CRC A/B will manage and support regulatory and operational aspects of an investigator-initiated drug trial, as well as other device and/or drug trials and research studies as assigned.

The day-to-day responsibilities of the CRC-A include recruitment and enrollment; completing paper case report forms (CRFs) and transferring data to eCRFs in a dedicated electronic data capture (EDC) system; responding to regulatory and operational queries in a timely manner; safety monitoring and submitting AEs, SAEs, and UADEs reports to the Investigator, Abramson Cancer Center (ACC), FDA, and Institutional Review Board (IRB) per protocol, federal, and institutional guidelines; preparing and drafting regulatory correspondence ; data collection and vendor oversight in the OR per institutional policies; collection, storage, and shipping of biospecimens per protocol and institutional policies; reviewing and approving trial billing; organizing and maintaining the accuracy of all study documentation; and preparing for and participating in study meetings and site visits.

These responsibilities will be done with regular to mínimal staff supervision.

The CRC-B's day to day responsibilities include all of the above in addition to other duties as required. These responsibilities will be done with mínimal to no staff supervision.

Additional duties also include submitting regulatory correspondence; device/drug accountability activities in conjunction with the Investigational Drug Services at UPHS and/or device supplier; ongoing study maintenance and oversight within institutional/study systems such as PennCTMS and PennChart; and assuring the accuracy of all study documentation.

The day-to-day responsibilities of the CRC-A include recruitment and enrollment; completing paper case report forms (CRFs) and transferring data to eCRFs in a dedicated electronic data capture (EDC) system; responding to regulatory and operational queries in a timely manner; safety monitoring and submitting AEs, SAEs, and UADEs reports to the Investigator, Abramson Cancer Center (ACC), FDA, and Institutional Review Board (IRB) per protocol, federal, and institutional guidelines; preparing, drafting, and submitting regulatory correspondence; device/drug accountability activities in conjunction with the Investigational Drug Services at UPHS and/or device supplier; data collection and vendor oversight in the OR per institutional policies; ongoing study maintenance and oversight within institutional/study systems such as PennCTMS and PennChart; collection, storage, and shipping of biospecimens per protocol and institutional policies; reviewing and approving trial billing; organizing, maintaining, and assuring the accuracy of all study documentation; and preparing for and participating in study meetings and site visits.

These responsibilities will be done with regular to mínimal staff supervision.

Position is conting