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This job was posted by https://illinoisjoblink.illinois.gov : For more information, please see: https://illinoisjoblink.illinois.gov/jobs/12317378 Department

BSD CCC - CCT Pod1

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

This role maintains clinical trial 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 submission of documentation to required internal committees and groups.

Responsibilities

• Prepares and submits materials to the IRB and other applicable internal review committees, including submission of new study applications, amendments, and continuing reviews.
• Creates and maintains site regulatory files for each assigned study.
• Communicates updates and changes (e.g. protocol amendments) to the clinical research team and sponsor/funding agencies.
• Participates in internal clinical research audit program as assigned.
• Acts as the primary regulatory liaison for external sites participating in clinical research projects coordinated by the University of Chicago, including distribution of protocol documents and amendments, review of site consent forms, and collection of site specific essential documents (IRB approvals, Form FDA 1572, staff qualifications and signatures, etc.), and maintenance of up-to-date regulatory files for external participating sites as assigned.
• Prepares and collects all necessary documents to activate protocols (e.g. consent forms, Form FDA 1572, etc.).
• Prepares protocol updates, coordinates weekly program meetings, and distributes relevant updates to participating sites as applicable.
• Coordinates department or clinic compliance with a moderate level of guidance.
• 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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Preferred Qualifications

Experience:

• Two years of clinical research or directly related experience.
• Prior clinical trial regulatory experience.
• Completion of a certificate or degree program in clinical trial management /regulatory affairs or directly related field.

Technical Skills or Knowledge:

• Solid understanding of regulations covering clinical trials/human subjects research.
• Excellent computer skills, including familiarity with Microsoft Office (Word, Excel, Outlook) and Adobe Acrobat.
• Familiarity with clinical trial management systems and/or databases.

Preferred Competencies

• Excellent written and interpersonal skills.
• Effectively present oral and written information.
• Analytical, problem-solving, and decision making skills.

Application Documents

• Resume/CV (required)
• Cover Letter (required)

When applying, the document(s) MUSTbe uploaded via the My Experience page, in the section titled Application Documents of the application.

Job Family

Legal & Regulatory Affairs

Role Impact