Oncore Compliance & Monitoring Analyst

OnCore Compliance & Monitoring Analyst

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 include conducting routine and targeted monitoring of clinical research study records to assess compliance with institutional policies, regulatory requirements, and established research workflows. The Analyst performs reconciliation of clinical research data across CTMS and related institutional systems to ensure accuracy, completeness, and data integrity. They review study lifecycle documentation—including approvals, amendments, enrollment data, and protocol records, to identify discrepancies, missing information, and data quality issues.

The role evaluates adherence to institutional SOPs and processes related to study activation, maintenance, amendments, enrollment, and study closure activities. They document monitoring findings and prepare formal reports summarizing observations, risk areas, trends, and recommended corrective and preventive actions (CAPAs). The Analyst communicates findings to principal investigators, study teams, and institutional stakeholders, providing clear guidance on remediation steps and process improvements.

They track corrective and preventive actions through resolution and verify implementation and effectiveness of remediation efforts. The position collaborates with Research Compliance, HRPP, and other key stakeholders to support monitoring activities and promote consistent research administration practices. They contribute to the development and maintenance of monitoring plans, review methodologies, audit procedures, and quality assurance metrics. The Analyst analyzes monitoring outcomes to identify trends, recurring issues, and systemic risks, and develops summary reports to support operational improvement efforts.

They provide education and guidance to research personnel on institutional requirements, system use, documentation standards, and best practices. The role serves as a subject matter resource for clinical research systems compliance, data integrity, and quality assurance processes. The Analyst coordinates department or clinic compliance with a moderate level of guidance. They prepare, complete, and submit all compliance documentation on a routine basis.

Coordinates compliance committee meetings. Performs other related work as needed.

Minimum requirements include a college or university degree in a related field and knowledge and skills developed through 2-5 years of work experience in a related job discipline. Preferred qualifications include a bachelor's degree, 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, and experience conducting audits, monitoring reviews, or quality assurance assessments.

Preferred competencies include 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, and proficiency with Microsoft Office applications including Word, Excel, PowerPoint, and Teams.

The position is located in an office environment. Application documents required include a resume and cover letter.