Research Quality Manager at The University of Chicago in Chicago, Illinois

Job Description:

Department



BSD CCC - Quality Core



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 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 compliance committee formation.


Facilitates and monitors the daily activities of investigator initiated clinical research and clinical trials for the program Lead by Dr. Rita Nanda, The Chicago Breast Cancer Research Consortium. Performs a variety of duties involved in the initiation of new clinical trials as well as in the collection, documentation, analysis and reporting of clinical research and clinical trial data, including DSM reports. Serves as primary liaison between the CTSO-, Quality Unit, and participating sites of the Chicago Breast Cancer Research Consortium.



Responsibilities

• Works closely with the Chicago Breast Cancer Research Consortium and the CTSO-Quality Unit to facilitate the opening and monitoring of the program's investigator initiated trials.
  
  


• Participates in the monthly Chicago Breast Cancer Research Consortium Operations Management calls and reports on overall status of each applicable trial including overall enrollment numbers.
  
  


• Promotes and encourages innovative new ideas for future clinical research projects and collaboration between the Chicago Breast Cancer Research Consortium, industry partners and any additional externals partner, such as the Lynn Sage Breast Cancer Foundation.
  
  


• Partners and collaborate with the Clinical Research Managers, Principal Investigators, and other key stakeholders to facilitate the timely opening of investigator initiated trials.
  
  


• Helps to ensure the clinical research enterprise including all participating sites in the Chicago Breast Cancer Research Consortium are adhering to the protocol documents as well as all related regulatory policies and guidelines, including federal, state, local, as well as the policies and procedures outlined by the University of Chicago Comprehensive Cancer Center.
  
  


• Oversees multiple projects at a time, and therefore must have strong time management skills in addition to working both independently and in a team environment. Ensures all Principal Investigator(s) and study teams adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures, including monitoring standards and guidelines.
  
  


• Verifies that trial data entered on the Case Report Form is consistent with patient clinical notes and other source documentation (source data verification).
  
  


• Coordinates upcoming and ongoing monitoring assignments while meeting expected timelines for completion of monitoring activities and submission of written monitoring reports for assigned studies.
  
  


• Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
  
  


• 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.

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Work Experience:

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

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Certifications:




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Preferred Qualifications




Education:

• Bachelor's Degree.
  
  

Experience:

• One year of Monitoring experience.
  
  


• University or Academic Medicine administrative experience.
  
  


• Clinical research or Academic Research experience.
  
  

Working Conditions

• Ability to bend, crouch, or stoop.
  
  


• Ability to lift loads up tp 49lbs.
  
  


• Work will be performed through a combination of remote data review and onsite monitoring visits (Hyde Park Campus) and meetings; therefore, a willingness and ability to work remotely and in person is required.
  
  


• Able to attend any Chicago Breast Cancer Research Consortium Conferences (10% travel).
  
  

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



Exempt



Pay Frequency



Monthly



Scheduled
Weekly Hours



40



Benefits Eligible



Yes



Drug Test Required



No



Health Screen Required



No



Motor Vehicle Record Inquiry Required



No



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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