University of Wisconsin - Madison

Position Vacancy Listing

PVL # 227727

Position Summary:
The Research Specialist, working title Clinical Research Study Coordinator, works within the UW - Madison School of Medicine and Public Health, Department of Radiology in the management of clinical trials. This involves participating in the daily management of research subjects enrolled in clinical trials and administrative management of clinical research trial activity for industry-sponsored, National Institute of Health (NIH) funded and investigator-initiated trials. Recruitment of volunteers, scheduling, data collection and all associated coordinator assessments necessary to a given protocols' completion are included in the responsibilities. It is the Department's mission to foster and support innovative research.

Principal duties:
The Clinical Research Study Coordinator will work in collaboration with the Principal Investigator, ancillary staff, including but not limited to physicians, medical physicists, nursing personnel, technologists, associated faculty, researchers, and graduate students in the management of clinical trials for the Department of Radiology. Studies are conducted within Wisconsin Institutes for Medical Research (WIMR), UW Health Clinics, UW Hospital (UWH) or Health Emotions Research Institute (HERI). This involves participating in the daily management of research subjects enrolled in clinical trials and administrative management of clinical research trial activity for industry-sponsored, National Institute of Health (NIH) funded, and investigator-initiated trials. Recruitment of volunteers, scheduling, data collection and all associated coordinator assessments necessary to a given protocols' completion are included in the responsibilities. The Study Coordinator is expected to follow the policies, procedures, guidelines and standards for excellence and professionalism established by the UW, Department of Radiology, Institutional Review Board (IRB), NIH, Federal Drug Administration (FDA), Clinical and Translational Research Core (CTRC), Data Safety Monitoring Board (DSMB), industry sponsors, and other organizations, including Good Clinical Practice (GCP).

Overall responsibilities include, but may not be limited to:

(30%) Recruit and screen potential study participants and present research protocols, including possible risks and benefits of study participation, required study visits and procedures, the participant's rights as a research subject, and obtain informed consent.

(30%) Schedule study visits and imaging scans. Collect data on study participants enrolled in research protocols. This data collection will involve direct research participant communication and may include collecting data from the subject's medical records. Data will be documented in electronic or paper case report forms; these include detailed medical histories, laboratory and procedure test results, concomitant medications, adverse events, and serious adverse events that will be reported to the sponsor, the UW and outside institutional review boards. Maintain study folders (paper and/or electronic) in standard Radiology Research Program format. Maintain regulatory binders. Manage study data that is consistent with UW compliance standards.

(25%) Provide effective, timely and on-going communication with the research teams regarding the status of a protocol¿s progress.

(5%) Ensure confidentiality of information under the Health Insurance Portability and Accountability Act (HIPAA). Maintain HIPAA compliance with any protected health information related to the duties described at all times.

(5%) Prepare informational materials, conduct in-services, and answer queries from study participants and health care providers related to the medical care of research participants and maintaining compliance with each study protocol.

(5%) Assist in preparation and submission of documents for research trials, including departmental research applications; protocols, DSMB, and NIH reports, and CTRC applications and reviews.

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