Oncore Compliance & Monitoring Analyst

University of Chicago•Hyde Park, IL

19h

About The Position

The OnCore Compliance & Monitoring Analyst supports the integrity, accuracy, and regulatory compliance of clinical research data in the Clinical Trial Management System (CTMS), OnCore. As part of the Research Systems & Coverage Analysis Unit within the Office of Clinical Research, the Analyst reviews and evaluates clinical research records for completeness, consistency, and alignment with institutional policies and applicable regulatory requirements. The role partners with study teams and institutional stakeholders to improve research data quality and operational consistency across the clinical research enterprise. With a moderate level of direction, the Analyst conducts routine and targeted reviews of OnCore records, reconciles data across integrated research systems, identifies discrepancies, and assesses compliance with required documentation and data standards. The Analyst documents findings, recommends corrective actions, tracks remediation, supports training, and contributes to continuous quality improvement. The position also serves as a resource for best practices in clinical research data management and OnCore use, and may coordinate internal audits and compliance committee activities.

Requirements

College or university degree in a related field.
2–5 years of work experience in a related job discipline.
Knowledge and skills developed through related work experience.

Nice To Haves

Clinical research experience, such as regulatory compliance, study coordination, quality assurance, monitoring, auditing, or related research activities.
Experience using the Clinical Trial Management System, OnCore.
Experience conducting audits, monitoring reviews, or quality assurance assessments.
Proficiency with 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.
A college or university degree in a related field.

Responsibilities

Conduct routine and targeted monitoring of clinical research study records for compliance with institutional policies, regulatory requirements, and research workflows.
Reconcile clinical research data across CTMS and related institutional systems to ensure accuracy, completeness, and data integrity.
Review study lifecycle documentation, including approvals, amendments, enrollment data, and protocol records, for discrepancies, missing information, and data quality issues.
Evaluate adherence to institutional SOPs and processes for study activation, maintenance, amendments, enrollment, and closure.
Document monitoring findings and prepare formal reports summarizing observations, risk areas, trends, and recommended corrective and preventive actions (CAPAs).
Communicate findings and remediation guidance to principal investigators, study teams, and institutional stakeholders.
Track corrective and preventive actions through resolution and verify that remediation has been implemented and is effective.
Collaborate with Research Compliance, HRPP, and other stakeholders to support monitoring and consistent research administration practices.
Contribute to the development and maintenance of monitoring plans, review methodologies, audit procedures, and quality assurance metrics.
Analyze monitoring outcomes to identify trends, recurring issues, and systemic risks, and prepare summary reports to support operational improvement.
Educate and guide research personnel on institutional requirements, system use, documentation standards, and best practices.
Serve as a subject matter resource for clinical research systems compliance, data integrity, and quality assurance processes.
Coordinate department or clinic compliance with a moderate level of guidance.
Prepare, complete, and routinely submit compliance documentation.
Coordinate compliance committee meetings.
Perform other related work as needed.