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Department

BSD OCR - Operations Infrastructure Support

About the Department

The Office of Clinical Research (OCR) is dedicated to supporting the infrastructure for the management and administration of clinical research at The University of Chicago as well as individual research programs with the goal of improving communication, consistency, and collaboration across the Biological Sciences Division and UChicago Medicine.
To mission of the OCR is to catalyze clinical research by providing expertise, resources, infrastructure, and systems that facilitate clinical research operations and enable collaboration across the enterprise while promoting compliance and human subject protection on behalf of our diverse community of patients and volunteers.

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.
The OnCore Compliance & Monitoring Analyst supports the integrity, accuracy, and regulatory compliance of clinical research data within the Clinical Trial Management System (CTMS), OnCore.
This role is responsible for the review, monitoring, and evaluation of clinical research records to ensure completeness, consistency, and alignment with institutional policies and applicable regulatory requirements.
As a member of the Research Systems & Coverage Analysis (RSCA) Unit within the Office of Clinical Research, this position partners closely with study teams and institutional stakeholders to strengthen research data quality and operational consistency across the clinical research enterprise.
The Analyst performs routine and targeted reviews of OnCore records, identifies discrepancies across integrated research systems, and assesses adherence to required documentation and data standards.
This role provides recommendations for corrective actions, supports resolution of identified issues, supports training activities, and contributes to continuous quality improvement efforts. The position also serves as a resource for best practices in clinical research data management and OnCore utilization, helping promote standardized and compliant research operations across the institution.

Responsibilities

• Conducts routine and targeted monitoring of clinical research study records to assess compliance with institutional policies, regulatory requirements, and established research workflows.

• Performs reconciliation of clinical research data across CTMS and related institutional systems to ensure accuracy, completeness, and data integrity.

• Reviews study lifecycle documentation-including approvals, amendments, enrollment data, and protocol records, to identify discrepancies, missing information, and data quality issues.

• Evaluates adherence to institutional SOPs and processes related to study activation, maintenance, amendments, enrollment, and study closure activities.

• Documents monitoring findings and prepares formal reports summarizing observations, risk areas, trends, and recommended corrective and preventive actions (CAPAs).

• Communicates findings to principal investigators, study teams, and institutional stakeholders, providing clear guidance on remediation steps and process improvements.

• Tracks corrective and preventive actions through resolution and verifies implementation and effectiveness of remediation efforts.

• Collaborates with Research Compliance, HRPP, and other key stakeholders to support monitoring activities and promote consistent research administration practices.

• Contributes to the development and maintenance of monitoring plans, review methodologies, audit procedures, and quality assurance metrics.

• Analyzes monitoring outcomes to identify trends, recurring issues, and systemic risks, and develops summary reports to support operational improvement efforts.

• Provides education and guidance to research personnel on institutional requirements, system use, documentation standards, and best practices.

• Serves as a subject matter resource for clinical research systems compliance, data integrity, and quality assurance processes.

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

• 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

Education:

• Bachelor's degree.

Experience:

• Clinical research experience such as regulatory compliance, study coordination, quality assurance, monitoring, auditing, or related research activities.

• Experience utilizing the Clinical Trial Management System, Oncore.

• Experience conducting audits, monitoring reviews, or quality assurance assessments.

Preferred Competencies

• Proficiency with the Clinical Trial Management System, OnCore.

• Experience with electronic IRB systems.

• Knowledge of human subject research regulations and institutional research administration processes.

• Knowledge of Good Clinical Practice (GCP), FDA regulations, and applicable institutional policies.

• Proficiency with Microsoft Office applications including Word, Excel, PowerPoint, and Teams.

Working Conditions

• Office environment.

Application Documents

• Resume (required)

• Cover Letter (required)

The University of Chicago uses AI-assisted tools to streamline and augment some recruitment processes; however, AI is not used to make hiring decisions.
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 equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, 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.

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.

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.