Sr. Clinical Research Coordinator

Sr. Clinical Research Coordinator

Location: Chicago, IL

Time Type: Full time

Posted On: Posted 4 Days Ago

Job Requisition ID: JR27875

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.

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, and 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.

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.
• May supervise two staff.
• Performs other related work as needed.

Minimum Qualifications:

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

Work Experience: Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.

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) MUST be 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.

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.

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.