Coordinates and manages multiple active cooperative group, investigator initiated and pharmaceutical company clinical trials for the section of gynecologic oncology.
Completes pre-study site qualification questionnaires, performs protocol schema review, arranges and attends site qualification and initiations visits for all new trials.
Liaises 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.
Handles regulatory submissions of investigator initiated protocols including revisions of consent forms and protocol narratives for amendments and continuing review.
Coordinates study monitor visits.
Manges registration multiple patients on clinical trials 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.
Prepares and submits new IRB protocols and consent forms to the institutional review board for approval.
Guides and advises investigators and research nurses regarding protocol eligibility, treatment guidelines and schedules, dose reductions, and required assessments.
Communicates with patients and family members regarding protocol requirements, timelines and scheduling of screening assessments.
Facilitates translational research specimen collection including scheduling appointments, kit preparation, requests for pathology specimens from outside hospitals, and shipment of specimens.
Coordinates quality of life assessments with nursing staff and patients.
Prepares weekly data and safety minutes and presents review of on-study subjects.
Submits requests for digital radiology if necessary.
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.
2-5 years of work experience in a related job discipline.
Background in research and OBGYN/Oncology.
Healthcare and/or academic medical center experience.
Working knowledge of IRB protocols.
Attention to detail.
Work with limited supervision.
Cover letter (preferred)
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