Additional Information
University Overview
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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 A
Job Profile Title
Clinical Research Coordinator A
Job Description Summary
Renal division in the department of medicine supports a diverse group of investigators, involving work on a wide spectrum of clinical
trials ranging from phase I to IV, investigator and industry initiated trials. This position is responsible for study coordination for
investigator-initiated studies, multi-center research studies, and patient-oriented clinical and translational research projects within the
Renal, Electrolyte, and Hypertension Division. The position involves working directly with study physicians, research nurses, and
other research staff at Penn and at other sites.
The position will help advance the research mission of the Division and University and show vigilance in patient safety, protocol
compliance, and data quality. It requires adherence to all University of Pennsylvania, IRB, and FDA guidelines and may require
working off site and flexible hours.
Job Description
Job Responsibilities
Screen, recruit and enroll consenting patients using Good Clinical Practice guidelines and conduct compliance monitoring of study participants. 25% 5
2 Conduct study related visits, including procedures such as blood draws, vitals, medical history, ECGs, processing and shipping of biological specimens and manage study data and regulatory files per GCP. Also includes: subject recruitment, informed consent, chart maintenance and data entry.
Work with Regulatory Affairs Specialist to prepare for audits, review regulatory binders, perform internal audit and other QA activities, and handle monitor/audit visits with CROs, the FDA and other entities.
Ordering and stocking supplies, maintaining equipment
With supervision, assist in preparation of research protocols and documents.
With the help of the project manager, manage/coordinate/organize the daily work of research assistants for tasks such as recruitment, study visits, and regulatory, and train them in these tasks. Attend Investigator Meetings and communicate meeting information to the study team.
Perform additional duties as assigned
CONTINGENT UPON FUNDING
Upenn · Smilow Center For Translational