This job was posted by https://illinoisjoblink.illinois.gov : For moreinformation, please see:https://illinoisjoblink.illinois.gov/jobs/11599441 Department

　　BSD CCC - Quality Core

　　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 performs routine assignments related to the documentation,analysis, and reporting of research data. Provides input to support thestrategic, administrative, operational, and financial decisions thatimpact clinical research conducted across the University.

　　Responsibilities

　　The Clinical Trials Monitor helps to ensure compliance of theclinical research enterprise with all related regulatory policiesand guidelines, including federal, state, local, as well as thepolicies and procedures outlined by the Cancer Center.Under the direction of Clinical Trials Support Office, s/he willassist in the design, development, implementation, and conduct of aneffective monitoring program in accordance with Good ClinicalPractice, institutional policies and procedures, and researchprotocols.The Clinical Trials Monitor will ensure that, for those clinicaltrials assigned for monitoring, the appropriate and requiredmonitoring tasks and related activities occur as outlined in themonitoring plan and in compliance with all related regulatorystandards.Monitoring will be performed through a combination of remote datareview and onsite monitoring visits (Hyde Park Campus); therefore, awillingness and ability to work remotely and in person is required.The Clinical Trials Monitor is responsible for multiple projects ata time, and must have strong time management skills in addition toworking both independently and in a team environment.Ensure all Principal Investigator(s) and study teams adhere tocurrent FDA regulations, applicable ICH/GCP guidelines, localpolicies and standard operating procedures, including monitoringstandards and guidelines.Adhere to the UCCCC Data Safety Monitoring Plan; e.g. monitoringvisit type, frequency, and required critical monitoring activitiesby utilizing monitoring tracking forms and other monitoring relatedtools and templates.Verify that trial data entered on the Case Report Form is consistentwith patient clinical notes and other source documentation (sourcedata verification). Independently coordinate upcoming and ongoingmonitoring assignments while meeting expected timelines forcompletion of monitoring activities and submission of writtenmonitoring reports.Assist in the development and writing of clinical trial monitoringplans.Participates in Cancer Center staff meetings.Provide recommendations and guidance to study specific monitoringteams and assist in audit readiness and preparation.Participate in regular monitoring team group meetings.Coordinates and may participate in quality assurance reviewsconducted by study sponsors, federal agencies, or speciallydesignated review groups.Analyzes study-related documentation, such as protocol worksheets,procedural manuals, adverse event reports, institutional reviewboard documents, or progress reports.Performs other related work as needed.Minimum Qualifications

　　Education:

　　Minimum requirements include a college or university degree in relatedfield.

　　---

　　Work Experience:

　　Minimum requirements include knowledge and skills developed through---

　　Certifications:

　　---

　　Preferred Qualifications

　　Education:

　　Bachelor\'s degree.Experience:

　　Progressively responsible clinical trials experience.

　　Monitoring experience.

　　U