Regulatory Assistant

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 credentials (training, licensure, and related items) in investigator site files.

• Provides administrative support to regulatory team including supply ordering, meeting scheduling, drafting meeting minutes, and documenting archiving.

• Utilizes analytical thinking, attention to detail, and problem-solving skills.
• Assists with department or clinic compliance with a high level of guidance.
• Helps prepare, 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 vocational training, apprenticeships or the equivalent experience in related field (not typically required to have a four-year degree).

Work Experience:

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

Certifications:

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Preferred Qualifications

Experience:

• Prior work experience within office environment.
• Prior data entry experience.

Preferred Competencies

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and Adobe Acrobat.

• Ability to communicate effectively in written and oral formats.

• Ability to develop proficiency with new software and tools as needed.

• Strong attention to detail and organizational skills with the ability to multitask and meet deadlines in a fast-paced work environment. 

• Strong interpersonal skills and ability to interact by phone, email, online meetings or in person with faculty and administrative staff at the University and occasionally with staff of federal government and other institutions and organizations.

Application Documents

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

The University of Chicago uses AI-assisted tools to streamline and augment some recruitment processes; however, AI is not used to make hiring decisions.

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

Job Family

Legal & Regulatory Affairs

Role Impact

Individual Contributor

Scheduled Weekly Hours

40

Drug Test Required

No

Health Screen Required

No

Motor Vehicle Record Inquiry Required

No

Pay Rate Type

Hourly

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FLSA Status

Non-Exempt

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Pay Range

$19.23 - $26.44

The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.

Benefits Eligible

Yes

The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.

Posting Statement

The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, 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.

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.

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.

The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: http://securityreport.uchicago.edu. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.