This job was posted by https://illinoisjoblink.illinois.gov : For moreinformation, please see:https://illinoisjoblink.illinois.gov/jobs/11611395 Department

　　BSD CCC - Network Oncology Research

　　About the Department

　　The University of Chicago Comprehensive Cancer Center (UCCCC) is anintegral component of the Biological Sciences Division (BSD). The BSD isthe largest of four Divisions of the University and includes thePritzker School of Medicine. UCCCC administers four establishedscientific programs, and the NCI-sponsored Cancer Center Support Grantprovides funding for ten Shared Resources. The Comprehensive CancerCenter is comprised of over 150 faculty members from twenty departmentswith members currently being awarded over \$47 million in total directcosts in peer-reviewed cancer research grants, and \$28 million innon-peer reviewed grants and contracts. The activities of the Center arebroad and varied, including research, training and education,communications, fundraising, marketing, clinical trials management andcommunity outreach.

　　UCCCC has one of the largest cancer clinical trials programs in thecountry and in the Chicago area with nearly 500 adult and pediatrictherapeutic trials actively accruing patients. Many of these studies areinvestigator-initiated, including Phase I or I/II trials, demonstratingUCCCC commitment to translate basic research findings to the clinicthrough proof-of-principle and early phase studies. UCCCC opens over 250new trials each year and accrues approximately 900 participants totherapeutic trials each year.

　　Job Summary

　　The job independently manages the collection, documentation, analysis ofclinical trial data, and reporting of clinical research data. Providesinput into the strategic, administrative, operational, and financialdecisions that impact clinical research conducted across the University.

　　The Senior Clinical Research Coordinator (Sr CRC) is a specializedresearch professional working with and under the direction of theclinical Principal Investigator (PI). While the Principal Investigatoris primarily responsible for the overall design, conduct, and managementof clinical trials, the Sr CRC oversees, facilitates and coordinates thedaily activities of complex clinical trials and plays a critical role inthe conduct of the studies to ensure compliance with federal andinstitutional regulations. The Sr CRC acts as a leader within thedepartment/unit through improving clinical research practice and servesas a resource to others. By performing these duties, the Sr. CRC workswith the PI, department, sponsor, and institution to support and provideguidance on the administration of the compliance, financial, personneland other related aspects of the clinical studies.

　　Responsibilities

　　Assist with or plan and implement the clinical study\'s goals andobjectives; organize patient enrollment planning; conduct qualityassurance activities, compile and analyze data; process blood and urinespecimens.

　　Act as a liaison with medical staff, university departments, ancillarydepartments and/or network facilities.

　　Serve as a resource person or act as a consultant within area ofclinical expertise.

　　Act as a leader within the department/unit through improving clinicalresearch practice and serving as a resource.

　　Maintain working knowledge of current protocols, and internal SOPs.

　　Be accountable for high standards of clinical research practice andassist in the development of accountability in others.

　　Develop and implement procedures, maintain records, track progress, andconduct quality assurance on data collected.

　　Oversee and participate in the coordination and conduct of complexclinical research studies and ensure compliance with federal andinstitutional regulations. Prepare, submit, and assist Investigatorswith multiple levels of research documentation (i.e. IRB submissions educational materials, reports, grant renewal reports, and study forms).

　　Provide Investigators with guidance regarding protocol requirements.Maintain regulatory documentation.

　　Assist other research personnel with reports to regulatory agencies,such as the IRB, FDA and Data and Safety Review Committee.

　　Prepare for and assist with audits, inspections, and monitoring visitsfrom regulatory agencies or sponsors.

　　Provide direct supervision of other CRC staff, including but not limitedto, hiring/firing, performance evaluations, disciplinary actions, managetime off, etc.

　　Attend continuing education and training opportunities relevant to jobduties.

　　Solves complex problems relating to data management and the analysis oflarge administrative datasets. Works independently to develop, manage,and report on key data and ensures timeliness of data and reportingsubmissions from multiple investigators.

　　Acts as a resource on the basics of clinical research and relatedaspects of clinical study for colleagues with less experience. Preparesand evaluates writing protocols, IRB submissions, grant applications,manuscripts, reports, and dissemination tools.

　　Performs other related work as needed.

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