Regulatory Affairs Manager at The University of Chicago in Chicago, Illinois

Job Description:

Department

BSD CCC - CCT Pod2



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 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 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 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

• Preparation and submission to the IRB and other applicable internal review committees including submission of new study applications, amendments, and continuing reviews.
  
  


• Creation and maintenance of site regulatory files for each assigned study.
  
  


• Communication of updates and changes (e.g. protocol amendments) to the clinical research team and sponsor/funding agencies.
  
  


• Participation in internal clinical research audit program (as assigned).
  
  


• Multi-site Regulatory Coordination (as assigned):Act 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, review of site consent forms, and collection of site specific essential documents (IRB approvals, Form FDA 1572, staff qualifications and signatures, etc.), maintenance of up-to-date regulatory files for external participating sites.
  
  


• Preparation and collection of all necessary documents to activate protocols (e.g. consent forms, Form FDA 1572, etc.).
  
  


• Preparation of protocol updates and coordination of weekly program meetings and distribution of relevant updates to participating sites (as applicable).
  
  


• Coordinates department or clinic compliance with a moderate level of guidance.
  
  


• Plans and executes 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.
  
  

Minimum Qualifications




Education:

Minimum requirements include a college or university degree in related field.



Work Experience:

Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.



Certifications:




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Preferred Qualifications




Experience:

• 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).
  
  

Preferred Competencies

• Solid understanding of regulations covering clinical trials/human subjects research.
  
  


• Excellent computer skills, including familiarity with Microsoft Office (Word, Excel, Outlook) and Adobe Acrobat.
  
  


• Familiarity with clinical trial management systems and/or databases.
  
  


• Excellent written and interpersonal skills. Ability to effectively present oral and written information.
  
  


• Analytical, problem solving, and decision making skills.
  
  

Application Documents

• Resume (required)
  
  


• Cover letter (required)
  
  

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



Scheduled
Weekly Hours

40



Drug Test Required



No



Health Screen Required



No



Motor Vehicle Record Inquiry Required



No



Pay Rate Type

Salary



FLSA Status

Exempt



Pay Range

$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.



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 Affirmative Action/Equal Opportunity/Disabled/Veterans and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, national or ethnic origin, 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.


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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