Oncore Compliance & Monitoring Analyst

University of Chicago; Chicago (IL); On-site; USD 70,000 - 110,000; Full time

Job summary

The University of Chicago Office of Clinical Research seeks an OnCore Compliance & Monitoring Analyst to help ensure regulatory compliance and data quality across the Clinical Trial Management System (OnCore). This role supports internal audits, CAPAs, and continuous quality improvement within the RSCA unit.

Working with study teams and institutional stakeholders, you will review records, identify discrepancies, and guide remediation, training, and best practices to promote compliant research

Qualifications

• Minimum requirements include a college or university degree in a related field.
• 2–5 years of work experience in a related discipline.
• Knowledge of regulatory compliance frameworks and clinical research principles.

Responsibilities

• Conduct routine and targeted monitoring of clinical research study records for compliance with policies and regulations.
• Reconcile clinical research data across CTMS and related systems to ensure accuracy and data integrity.
• Review study documentation (approvals, amendments, enrollment, protocols) for discrepancies and data quality issues.
• Assess adherence to SOPs and processes for activations, maintenance, amendments, enrollment, and closures.
• Document monitoring findings and prepare reports with CAPA recommendations and remediation guidance.
• Collaborate with Research Compliance, HRPP, and stakeholders to promote consistent research practices.

Education

Bachelor's degree in related field

Master's degree preferred

Job description

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: ---

Preferred Qualifications

• Education: College or university degree in related field.
• Experience: Clinical research experience such as regulatory compliance, study coordination, quality assurance, monitoring, auditing, or related research activities.
• E