Oncore Compliance & Monitoring Analyst

• →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. 

• College or university degree in related field.

• 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.

• 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.

• Office environment.

• Resume (required)

• Cover Letter (required)

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FLSA Status

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Pay Range

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.

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.

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