Regulatory Affairs Manager

Regulatory Compliance Coordinator

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 funds ten Shared Resources. The Comprehensive Cancer Center comprises 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's commitment to translating 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.

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.

Responsibilities include :

• Prepares and submits 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 the 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.
• Prepares and collects all necessary documents to activate protocols (e.g., consent forms, Form FDA 1572, etc.).
• Prepares protocol updates and coordinates weekly program meetings and distribution of 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 include a college or university degree in the related field and knowledge and skills developed through 2-5 years of work experience in a related job discipline.

Preferred qualifications include :

Preferred competencies include :

Working conditions include the ability to navigate the UChicago campus as required by the position and hybrid work arrangements may be considered.

Application documents include a resume (required) and a cover letter (preferred).