Sr. Clinical Research Coordinator
The University of Chicago

Job Info

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Department

BSD DFI - Staff

About the Department

The Duchossois Family Institute (DFI) at the University of Chicago is using cutting-edge technologies and developing facilities to accelerate clinical research and introduce novel interventions that optimize microbiome-mediated host defenses, with the goal of enhancing human health. By developing new knowledge about the interactions between the human body and the microbiome, the DFI is breaking new ground in therapies that will increase resistance to a wide range of diseases.

Job Summary

The DFI Clinical Research Studies Manager is a pivotal position that provides day to day project oversight and management to the clinical research coordinators and involves direct interactions with the UChicago Office of Clinical Research (OCR), the Clinical Trials office, Institutional Review Board (IRB). The clinical research studies manager serves as a liaison with the Federal Drug Administration (FDA) and various clinical sites to ensure compliance with protocol and applicable institutional and regulatory guidelines. The ideal candidate will provide day-to-day project management, data management, and clinical monitoring of all clinical research and interventional studies and will ensure that DFI-funded and supported clinical studies will be executed accurately and expeditiously and that IRB-approved protocols are meticulously adhered to.

Responsibilities

• Develops goals and executes operating procedures, practices, and guidelines for all clinical research study activities.
  
• Acts as a liaison with regulatory agencies (e.g., FDA), IRB, and Clinical Trial officials.
  
• Acts as liaison between contractors involved in research home visits.
  
• Maintain and develop regulatory documents per FDA reporting guidelines.
  
• Hires and establishes performance expectations for staff members.
  
• Manages and trains junior staff on the study protocols.
  
• Manage patient enrollment across all IRB-approved clinical studies.
  
• Assist in grant writing.
  
• Assist in the preparation of publications.
  
• Manage day-to-day research study operations for research staff and principal investigators (PIs).
  
• Oversee completion of study activities per protocol.
  
• Assist PI in proactive monitoring of patient safety and drug tolerability in interventional trials.
  
• Manage REDCap database and ensure correct data collection across multiple studies.
  
• Manage study budgets, invoicing, and study supplies.
  
• Accountable for all tasks in complex clinical studies.
  
• Performs various professional, organizational, and operational tasks under limited supervision. Acts as a resource on clinical research and related aspects of clinical study for other clinical research staff. Accountable for complex problem solving on assigned clinical research studies and professional tasks.
  
• May supervise two staff.
  
• 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 5-7 years of work experience in a related job discipline.
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Certifications:

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Working Conditions

• Physically capable of moderate physical activity to retrieve clinical specimens from various buildings on the university campus.
  

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

Research

Role Impact

Individual Contributor

FLSA Status

Exempt

Pay Frequency

Monthly

Scheduled Weekly Hours

40

Benefits Eligible

Yes

Drug Test Required

Yes

Health Screen Required

Yes

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.

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.

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