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BSD CCC - Quality Core

About the Department

The University of Chicago Comprehensive Cancer Center (UCCCC) is an integral component of the Biological Sciences Division (BSD). The BSD is the largest of four Divisions of the University and includes the Pritzker School of Medicine. UCCCC administers four established scientific programs, and the NCI-sponsored Cancer Center Support Grant provides funding for ten Shared Resources. The Comprehensive Cancer Center is comprised of over 190 faculty members from twenty departments with members currently being awarded over \$47 million in total direct costs in peer-reviewed cancer research grants, and \$28 million in non-peer reviewed grants and contracts. The activities of the Center are broad and varied, including research, training and education, communications, fundraising, marketing, clinical trials management and community outreach.

UCCCC has one of the largest cancer clinical trials programs in the country and in the Chicago area with nearly 500 adult and pediatric therapeutic trials actively accruing patients. Many of these studies are investigator-initiated, including Phase I or I/II trials, demonstrating UCCCC commitment to translate basic research findings to the clinic through proof-of-principle and early phase studies. UCCCC opens over 250 new trials each year and accrues approximately 900 participants to therapeutic trials each year.

Job Summary

The job maintains regulatory compliance programs, including the interpretation of systems to identify areas of risk and may coordinate internal audits. With a moderate level of direction, participates in compliance documentation, compliance training, and compliance committee formation.

Facilitates and monitors the daily activities of investigator initiated clinical research and clinical trials for the program Lead by Dr. Rita Nanda, The Chicago Breast Cancer Research Consortium. Performs a variety of duties involved in the initiation of new clinical trials as well as in the collection, documentation, analysis and reporting of clinical research and clinical trial data, including DSM reports. Serves as primary liaison between the CTSO-, Quality Unit, and participating sites of the Chicago Breast Cancer Research Consortium.

Responsibilities

• Works closely with the Chicago Breast Cancer Research Consortium and the CTSO-Quality Unit to facilitate the opening and monitoring of the program\'s investigator initiated trials.
• Participates in the monthly Chicago Breast Cancer Research Consortium Operations Management calls and reports on overall status of each applicable trial including overall enrollment numbers.
• Promotes and encourages innovative new ideas for future clinical research projects and collaboration between the Chicago Breast Cancer Research Consortium, industry partners and any additional externals partner, such as the Lynn Sage Breast Cancer Foundation.
• Partners and collaborate with the Clinical Research Managers, Principal Investigators, and other key stakeholders to facilitate the timely opening of investigator initiated trials.
• Helps to ensure the clinical research enterprise including all participating sites in the Chicago Breast Cancer Research Consortium are adhering to the protocol documents as well as all related regulatory policies and guidelines, including federal, state, local, as well as the policies and procedures outlined by the University of Chicago Comprehensive Cancer Center.
• Oversees multiple projects at a time, and therefore must have strong time management skills in addition to working both independently and in a team environment. Ensures all Principal Investigator(s) and study teams adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures, including monitoring standards and guidelines.
• Verifies that trial data entered on the Case Report Form is consistent with patient clinical notes and other source documentation (source data verification).
• Coordinates upcoming and ongoing monitoring assignments while meeting expected timelines for completion of monitoring activities and submission of written monitoring reports for assigned studies.
• Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
• Plans and executes internal and external audits and activities to support regulatory agency inspections.
• Prepares, completes and submits all compliance documentation on a routine basis. Coordinates compliance committee meetings.
• Performs other related work as needed.

Minimum Qualifications

Education:

Minimum requirements include a college or university degree in related field.

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Work Experience:

Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

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Certifications:

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