Clinical Research Coordinator (Breast Cancer Prevention) Cancer Center

Department: SOM KC Cancer Center Clinical Trials ----- Clinical Research

Position Title: Clinical Research Coordinator (Breast Cancer Prevention) Cancer Center Job Family Group: Professional Staff

Job Description: Summary:

Job Description

The Clinical Research Coordinator works collaboratively with multidisciplinary teams, research, and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research. This position manages assigned clinical research studies by supervising a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Monitors participants' progress including documenting and reporting adverse events. Participates in periodic quality assurance audits of protocols. The University of Kansas Cancer Center is the only National Cancer Institute designated Comprehensive Cancer Center in the region, 1 of only 57 in the nation to receive this distinction. Patients gain access to the most promising therapies, cutting-edge clinical trials and world class research. Job Responsibilities Under the direction of the principal investigator, review upcoming breast cancer prevention clinics and indicate possible eligible candidates for open trials for breast cancer risk reduction and communicate this information to the medical provider. Assist with recruitment and education of potential participants and perform detailed eligibility assessments of identified candidates. Schedule and perform or assist with performance of study procedures, as outlined in the protocol and within state and institutional scope of practice. Assist clinical staff with bio-sample collection, processing, handling, and shipping as outlined in the protocol and within institutional/KUMC policy. 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. Assist with study specific excel spread-sheet type protocol eligibility, demographics, evaluability and biomarker results summary to assist PI in monitoring study progression as well as gathering data for interim PMRC assessments and/ or presentations. 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. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice. Work Environment: This position will be 100% onsite due to the fact this is a patient facing role. Required Qualifications Work Experience: 4 years of relevant work experience. Education may be substituted for experience on a year for year basis. Experience with regulations governing clinical research (CFR, GCP, HIPAA). Experience with statutes and guidelines relevant to regulatory affairs in clinical research. Experience study budgets, contracts, and grant applications. Experience using MS Office products.