Clinical Trials Monitor 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 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 the documentation, analysis, and reporting of research data. Provides input to support the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University.



Responsibilities

• Helps to ensure compliance of the clinical research enterprise with all related regulatory policies and guidelines, including federal, state, local, as well as the policies and procedures outlined by the Cancer Center.
  
  


• Assists in the design, development, implementation, and conduct of an effective monitoring program in accordance with Good Clinical Practice, institutional policies and procedures, and research protocols.
  
  


• Ensures that, for those clinical trials assigned for monitoring, the appropriate and required monitoring tasks and related activities occur as outlined in the monitoring plan and in compliance with all related regulatory standards.
  
  


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


• Responsible for multiple projects at a time, and 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.
  
  


• Adheres to the UCCCC Data Safety Monitoring Plan; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring related tools and templates.
  
  


• Verifies that trial data entered on the Case Report Form is consistent with patient clinical notes and other source documentation (source data verification). Independently coordinate upcoming and ongoing monitoring assignments while meeting expected timelines for completion of monitoring activities and submission of written monitoring reports.
  
  


• Assists in the development and writing of clinical trial monitoring plans.
  
  


• Participates in Cancer Center staff meetings.
  
  


• Provides recommendations and guidance to study specific monitoring teams and assist in audit readiness and preparation.
  
  


• Participates in regular monitoring team group meetings.
  
  


• Assists with various professional, organizational, and operational tasks under direct supervision.
  
  


• Supports quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
  
  


• Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples.
  
  


• 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

Certifications:




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Preferred Qualifications




Education:

• Bachelor's degree.
  
  

Experience:

• Three years of Progressively responsible clinical trials experience.
  
  


• One year of monitoring experience.
  
  


• University or Academic medicine administrative experience.
  
  

Working Conditions

• Ability to bend, crouch, or stoop.
  
  


• Ability to lift loads up tp 49lbs.
  
  


• Hybrid work arrangements will be considered.
  
  

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

Research



Role Impact

Individual Contributor



Scheduled
Weekly Hours

40



Drug Test Required



Yes



Health Screen Required



Yes



Motor Vehicle Record Inquiry Required



No



Pay Rate Type

Salary



FLSA Status

Exempt



Pay Range

$59,000.00 - $71,500.00
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.


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. The Report can be accessed online at:http://securityreport.uchicago.edu.Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637. Apply Now