Regulatory Assistant

Job Summary

The Regulatory Assistant sits within the University of Chicago Medicine Comprehensive Cancer Center (UCCCC) Clinical Trials Support Office (CTSO). 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, including collecting 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 also supports 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 also supports 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.

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.