Department

BSD CCC - Clinical Trials Support Unit

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 150 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 provides basic technical support activities related to documents, analyzes, and reports on clinical research data. Provides input to support the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University.

Responsibilities

• Provides administrative support for the Clinical Trials Support Office. Specifically, provides administrative support to the Senior Director of Cancer Clinical Trials Support Office, including help and support of the Protocol Review and Monitoring System (PRMS), Clinical Data Protocol Management (CPDM) and Data Safety Monitoring Committee (DSMC).

• Schedules meetings, answers phones, delivers mail, orders supplies, archives documents, etc.

• Maintains clinical trials databases to ensure compliance with National Cancer Institute (NCI), Food and Drug Administration (FDA), and other applicable regulations and policies.

• Responsible for maintaining, collecting, and tracking documentation of investigator and research staff credentials and updating internal and sponsor required databases and files.

• Prepares monthly agenda in collaboration with DSMC Administrator, prepares Outcome Letters and follows up with outcome letters that need PI response.

• Updates DSMC tracking file and joins preparation meetings with DSMC Chair.

• Provides training and mentorship to student workers, education designees, and administrative staff in the conduct of regulatory support activities.

• Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.

• Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.

• Performs other related work as needed.

Minimum Qualifications

Education:

Minimum requirements include vocational training, apprenticeships or the equivalent experience in related field (not typically required to have a four-year degree).

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Work Experience:

Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications

Experience:

• Data entry experience.

• Demonstrated ability to communicate effectively in written and oral formats.

• Prior work experience in clinical research regulatory compliance, research operations, coordinator, or data management.

• Familiarity with MS Office applications.

Working Conditions

• Hybrid work arrangements will be considered.

Application Documents

• Resume (required)

• Cover letter (preferred)

Job Family

Research

Role Impact

Individual Contributor

FLSA Status

Non-Exempt

Pay Frequency

Biweekly

Scheduled Weekly Hours

40

Benefits Eligible

Yes

Drug Test Required

No

Health Screen Required

No

Motor Vehicle Record Inquiry Required

No

Posting Statement

The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, national or ethnic origin, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.

Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form.

We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange.

All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.

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