Regulatory Compliance Specialist
The University of Chicago

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 provides funding for ten Shared Resources. The Comprehensive Cancer Center is comprised of over 150 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 commitment to translate 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 job performs routine assignments related to regulatory compliance programs, including the interpretation of systems to identify areas of risk and coordinates internal audits. With a high level of direction, participates in compliance documentation, compliance training, and compliance committee formation.

Responsibilities

• Ensures regulatory compliance of clinical trials and other clinical research projects in accordance in with federal regulations, international guidance, and internal policies and process.
  
• Carries out regulatory study start-up activities and regulatory maintenance for assigned portfolio of studies, including preparing applications for submission to the Institutional Review Board (IRB) and other applicable internal review committees for new research projects and amendments and continuing reviews to ongoing studies.
  
• Creates and updates informed consent documentation in collaboration with investigators, sponsors, and internal review committees.
  
• Prepares, collects, and updates essential clinical research documentation (e.g. Form FDA 1572, financial disclosures, and other required documentation).
  
• Creates and maintains study essential regulatory files in accordance with applicable regulations and policies.
  
• Prepares for and participates in monitoring and auditing activities and addresses outstanding issues resulting from routine monitoring activities.
  
• Communicates with principal investigators, sub investigators, clinical research staff, and sponsors on protocol regulatory activities including preparation of protocol updates at weekly disease program meetings.
  
• Provides guidance to PIs, research team, auditors, and other affiliated staff related to the maintenance of regulatory compliance.
  
• Completes internal trainings as required.
  
• Maintains department or clinic compliance with a high level of guidance.
  
• Prepares, 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 a college or university degree in related field.
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Work Experience:
Minimum requirements include knowledge and skills developed through ---
Certifications:

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Preferred Qualifications

Experience:

• Prior work experience or exposure to a clinical research environment.
  
• Degree or certification in clinical research or related field.
  
• Project management experience.
  

Preferred Competencies

• Performs assigned tasks with a high level of oversight.
  
• Responsible for understanding and interpreting the Code of Federal Regulations, Institutional Review Board policies, and procedures as well as other regulatory policies regarding human subject research.
  
• Completion of human subjects and Good Clinical Practice training within 30 days of hire and maintaining compliance with training requirements (refresher training every 3 years).
  

Working Conditions

• Hybrid work arrangements will be considered.
  

Application Documents

• Resume (required)
  
• Cover letter (preferred)
  

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

Job Family

Legal & Regulatory Affairs

Role Impact

Individual Contributor

FLSA Status

Non-Exempt

Pay Frequency

Biweekly

Scheduled Weekly Hours

40

Benefits Eligible

Yes

Drug Test Required

No

Health Screen Required

No

Motor Vehicle Record Inquiry Required

No

Posting Statement

Employees must comply with the University's COVID-19 vaccination requirements. More information about the requirements can be found on the University of Chicago Vaccination GoForward.

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 Applicant Inquiry Form.

We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange.

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.

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