Research - Laboratory/Non-Laboratory, Staff/Administrative
Location: Hyde Park Campus
Coordinate and manage multiple active cooperative group, investigator initiated and pharmaceutical company clinical trials for the section of gynecologic oncology and department as a whole.
Complete pre-study site qualification questionnaires, perform protocol schema review, arrange and attend site qualification and initiation visits for all new trials.
Liaise with Office of Clinical Research, regulatory, investigational drug pharmacy, human imaging research office, Biofluids, and Human Tissue Resource Core regarding protocol requirements and submissions required for activation.
Handle regulatory submissions of investigator initiated protocols including revisions of consent forms and protocol narratives for amendments and continuing review.
Coordinate study monitor visits.
Registration of over multiple patients on clinical trial including the review of eligibility, maintenance of study charts, abstracting and recording medical record data including toxicities, serious adverse events, response evaluation criteria, protocol deviations and query resolution of all reported data for main and satellite sites.
Prepare and submit new IRB protocols and consent forms to the institutional review board for approval.
Guide and advise investigators and research nurses regarding protocol eligibility, treatment guidelines and schedules, dose reductions, and required assessments.
Communicate with patients and family members regarding protocol requirements, timelines and scheduling of screening assessments.
Facilitate translational research specimen collection including scheduling appointments, kit preparation, requests for pathology specimens from outside hospitals, and shipment of specimens.
Coordinate quality of life assessments with nursing staff and patients.
Prepare weekly data and safety minutes and present review of on-study subjects.
Submit requests for digital radiology.
Performs various aspects of clinical research, such as collecting and processing specimens, interviewing subjects, taking vital signs, and contributing to the case report.
Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
Performs other related work as needed.
Advanced degree in research, health care administration, or related field.
Pervious research experience.
Healthcare and/or academic medical center experience.
IRB protocol experience.
Attention to detail.
Ability to work with limited supervision.
Ability to meet deadlines.
Travel to our off-site ambulatory locations on an as-needed basis.
Cover Letter (preferred)
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Internal Number: JR11278
About University of Chicago (UC)
One of the world's premier academic and research institutions, the University of Chicago has driven new ways of thinking since our 1890 founding. Today, UChicago is an intellectual destination that draws inspired scholars to our Hyde Park and international campuses, keeping UChicago at the nexus of ideas that challenge and change the world.