Clinical Research Coordinator C

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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 This position will be a resource for best practices of managing NIH and Industry-sponsored clinical trials in the Neuroradiology Clinical Research Division. The coordinator will provide guidance to both study trials and device trials. The incumbent will be a liaison to departmental interaction such as the investigational team, the nursing units and sponsor. He/She will be a resource to other members of the team and will oversee the implementation of new clinical trials. Will review all new trials to help identify the challenges and opportunities discovered. Will problem-solve the challenges to implement a plan of action; will work with the project manager to ensure study procedures and regulatory submissions are completed in a timely manner. Will assist in the supervision and execution of research trials with the staff to ensure adherence to the protocol is followed and will audit the trials for compliance and enrollment which include a review of the data entry for accuracy and completeness and adverse event management. The coordinator will take an active role in study start-up through closeout, and preparation of trial audits and inspection. The coordinator will take a lead role supervising any inspection that takes place with the trials. Additional responsibilities include assistance with study coordination for research trials and other research activities to include site selection preparation, organizing and maintaining study documentation, database entry, resolving data queries, review of medical records, scheduling study-related tests in EPIC/Pennchart, Radiology, and other research systems; preparing and processing regulatory documents for submission to the IRB, and all regulatory committees from study start-up to completion. Interact with study sponsors, preparing and participating in study initiation visits, study audits, monitoring, and closeout visits. Perform other duties as assigned. Job Description Job Responsibilities The coordinator will provide guidance to both study trials and device trials. The incumbent will be a liaison to departmental interaction such as the investigational team, the nursing units and sponsor. He/She will be a resource to other members of the team and will oversee the implementation of new clinical trials. Will review all new trials to help identify the challenges and opportunities discovered. The coordinator will assist other research staff with participant recruitment and study coordination in the Neuroradiology Clinical Research Division. Organize and maintain study documentation, preparing and processing regulatory documents for submission to the IRB, and all regulatory committees from study start-up to completion. Data transfer and collection of imaging data for preparation of processing and analysis. Will problem-solve the challenges to implement a plan of action; will work with the project manager to ensure study procedures and regulatory submissions to the IRB are completed in a timely manner. Will supervise the execution of the trial with the staff to ensure adherence to the protocol is followed and will audit the trials for compliance and enrollment which include a review of the data entry for accuracy and completeness and adverse event management. The coordinator will take an active role in preparation of trial audits and inspection. The coordinator will take a lead role supervising any inspection that takes place with the trials. S/he will provide monthly updat

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