Department
BSD CCC - Clinical Trials Office
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 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.
Job Summary
The Regulatory Assistant sits within the University of Chicago Medicine Comprehensive Cancer Center (UCCCC) Clinical Trials Support Office (CTSO). The CTSO is organized into eight teams – biobanking, finance, informatics, network operations, study operations/data management, regulatory, training and education, and quality unit/investigator support.
This position serves as an essential support role dedicated to the CTSO regulatory team and provides administrative and business support to ensure compliance with clinical research regulations and guidance documents, internal policies, and National Cancer Institute (NCI) reporting requirements. The Regulatory Assistant is responsible for tracking and distribution of safety updates related to ongoing clinical trials conducted at the UCCCC. This will include collecting these updates from sponsor databases, portals, emails, or other secure methods of distribution, logging events in internal trackers, filing reports in electronic site files, and distributing reports for appropriate internal stakeholder reviews. The position will also support maintenance of essential documents required to support clinical research conduct including maintaining training documentation and relevant licensure, registering clinical research studies in national databases, accrual reporting, and other essential data entry tasks. The Regulatory Assistant will also support other administrative tasks such as supply ordering, meeting scheduling, and document archiving.
This entry-level role requires practical administrative and organizational skills, attention to detail, and the ability to manage multiple concurrent tasks in a fast-paced research environment. The incumbent receives guidance and direction from leadership and senior team members, with the expectation of growing into an independent contributor.
Responsibilities
Collects, tracks, and distributes essential safety updates to internal stakeholders. Maintains accurate records of report receipt and review in internal files to document compliance with internal policies and federal guidance.
Assists with data entry and clean-up in the institutional Clinical Trials Management System (CTMS).
Registers new clinical research projects in national databases and maintains and updates these study records according to federal and NCI requirements.
Enters clinical research accrual data in NCI or related systems. Liases with internal and external stakeholders and study teams to ensure accurate accrual reporting.
Maintains and updates site, investigator and staff research…