Clinical Research Coordinator - Surgery Urology

Under the direction of the principal investigator, recruit and educate potential patients for and evaluate potential patient eligibility for clinical trials. Maintain source documents and submit case report forms (CRFs) as required for clinical trials. Recognize and report adverse events/serious adverse events to the Principal Investigator, FDA, and sponsors. Perform study procedures, as outlined in the protocol and within state and institutional scope of practice. Assist clinical staff with phlebotomy and sample collection, processing, handling, and shipping as outlined in the protocol and within institutional/KUMC policy. Ensure adequate study supplies are being maintained. Track study expenditures and submit reimbursement requests for study equipment, supplies and study participants. Prepare documentation and participate in study monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and Project Manager, as required. Participate in quality assurance activities by reviewing clinical data in medical record charts, assessing pharmacy compliance with protocol criteria and reviewing study documentation to ensure compliance with GCP guidelines and FDA CFR. Work closely with the Research Institute and Human Research Protection Program and have a working knowledge of KUMC policies and procedures. Attend continuing education, research and training seminars as requested by manager. Four (4) years of experience in health sciences, nursing, biology, or related field. Relevant education may be substituted for experience on a year for year basis. Two (2) years of clinical research experience. Experience with clinical research regulations (FDA, GCP, IRB, HIPAA). Four (4) years of clinical research experience. Experience in department or division specific. Experience with REDCap, Epic, or similar data management systems. Computer skills Organization Communication Interpersonal skills Attention to detail Multitasking Resume Cover Letter https://www.kumc.edu/human-resources/benefits.

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