Upenn · Scheie Eye InstitutePrepare for this interview
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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 Job Profile Title Clinical Research Coordinator A Job Description Summary Assists in the management of clinical trials under direct supervision by coordinating patient screening, enrollment, data collection, and sample handling. Supports IRB submissions and helps prepare manuscripts, grant proposals, and presentations. Works closely with the Principal Investigator, manager, and study team to address study needs, implement approved changes, and monitor outcomes. Contributes to investigator-initiated, multi-center, and patient-oriented clinical and translational research studies. Job Description Job Responsibilities Adhere to an IRB approved protocol - Participate in the informed consent process of study subjects - Support the safety of clinical research patients/research participants - Coordinate protocol related research procedures, study visits, and follow-up care - Screen, recruit and enroll patients/research participants - Maintain study source documents - Report adverse events - Understand good clinical practice (GCP) and regulatory compliance - Educate subjects and their support members on protocol, study intervention, etc. - Comply with Institutional policies, standard operating procedures (SOPs) and guidelines - Must comply with federal, state, and sponsor policies Related responsibilities - Manage essential regulatory documents - Register and keep study up to date on CRMS - Complete case report forms (paper & electronic data capture) and address queries - Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie, DSMB, independent safety officer) - Facilitate pre-study, site qualification, study initiation, and monitoring visits - Facilitate study close out activities - Assist project manager(s) with study start-up - Attend and participate in team meetings - Collect, process and ship laboratory specimens - Schedule subject visits and procedures in EMR and keep track of visits - Complete subject visits per protocol in accordance to GCP - Retain records/archive documents after study close out - Develop Case Report Forms/Smartphrases in the EMR - Develop/edit informed consent document - Apply in depth knowledge of clinical research and independently coordinate the activities of 1 or more large-scale, complex multi-center / multi-institutional studies - Accountable for study oversight at one or more sites/institutions - Prepares study sites for internal/external regulatory audits (sponsor, FDA, NIH, etc) - Educates internal and external clinical staff, research teams and other coordinators; provides resources, and consulting on difficult protocols or projects - Assesses and critiques protocol feasibility and provides recommendations - May support 1 or more PI sponsored INDs or IDEs - Liaises between Research billing and the research team - Assist fellow research coordinators with studies as needed - Act as liaison for research subject, investigator, IRB, and sponsor. Other duties and responsibilities as assigned
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