Regulatory Assistant

Job Description:

• Administrative support: schedules meetings, answers phones, delivers mail, orders supplies, archives documents, etc.
• Protocol Registration and Reporting: Responsible for all aspects of trial registration and accrual reporting to ensure compliance with National Cancer Institute (NCI), Food and Drug Administration (FDA), and other applicable regulations and policies.
• Investigator/Staff Credentialing: Responsible for maintaining, collecting, and tracking documentation of investigator and research staff credentials and updating internal and sponsor required databases and files.
• Regulatory Support: Assists regulatory specialists as needed, including collection of study specific essential documents (Form 1572, financial disclosures, etc.), delegation documentation, preparing for monitoring and auditing activities; provides support to regulatory team for data entry into Clinical Trials Management System (CTMS) and other internal databases.
• Training and mentorship to student workers, education designees, and administrative staff in the conduct of regulatory support activities.
• Performs assigned tasks with high level of oversight.
• Maintains department or clinic compliance with a high level of guidance.
• Conducts 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.

Preferred Qualifications

Experience:

• Project management experience
• Prior work experience in clinical research regulatory compliance, research operations, coordinator, or data management

Preferred Competencies

• Demonstrated ability to communicate effectively in written and oral formats
• Familiarity with MS Office applications

Application Documents

• Resume (required)
• Cover letter (preferred)

The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, status as an individual with a disability, protected veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.

Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via the Applicant Inquiry Form.

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