Uchicago

Uchicago

Regulatory Affairs Manager, Comprehensive Cancer Center

Chicago, IL · Contract

Sponsorship not specified$65k-$90kDetected 12 days ago
Computer VisionStatisticsComplianceExcelClinical TrialsClinical ResearchFDA RegulatoryResearchCommunicationProblem SolvingMicrosoft OfficeRegulatory Affairs

About the role

  • This position maintains clinical trial 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 submission of documentation to required internal committees and groups.

Responsibilities

  • Creates and maintains the site of regulatory files for each assigned study.
  • Provides multi-site regulatory coordination 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
  • collection of site specific essential documents, including IRB approvals, Form FDA 1572, staff qualifications and signatures, etc.
  • Prepares and collects all necessary documents to activate protocols, such as consent forms and Form FDA 1572, etc.
  • Plans and executes internal and external audits and activities to support regulatory agency inspections.
  • Performs other related work as needed.

Requirements

  • include a college or university degree in related field.

Nice to have

  • Two years of clinical research or directly related experience.
  • ​Prior clinical trial regulatory experience.
  • Completion of a certificate or degree program in clinical trial management /regulatory affairs or directly related field.
  • Technical Skills or Knowledge:
  • Preferred Competencies
  • ​Excellent written and interpersonal skills.
  • Effectively present oral and written information.

Skills

  • ​Excellent computer skills, including familiarity with Microsoft Office (Word, Excel, Outlook) and Adobe Acrobat.
  • ​Familiarity with clinical trial management systems and/or databases.
  • Solid understanding of regulations covering clinical trials/human subjects research.
  • ​Excellent written and interpersonal skills. Effectively present oral and written information.
  • ​Analytical, problem solving, and decision making skills.
  • Resume/CV (required)
  • Cover Letter (preferred)

Compensation

  • $65,000.00 - $90,000.00 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.
  • 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.

Benefits

  • 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.
  • Benefits Eligible

Equal opportunity

  • 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.
  • Job seekers in need of a reasonable accommodation to complete the

Visa & Work Authorization

  • Communicates updates and changes, such as protocol amendments, to the clinical research team and sponsor/funding agencies
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This listing is sourced directly from Uchicago's careers page and normalized into a canonical job model.