Compliance Auditor

Job Summary

The Compliance Auditor maintains and advances the regulatory compliance program for clinical research operations, conducting audits, monitoring activities, and quality assurance assessments to identify risk and drive continuous improvement. The position prepares formal audit reports, tracks corrective and preventive actions, and serves as a subject matter resource on research compliance. With moderate direction, the role participates in compliance documentation, training, and committee activities.

Responsibilities

• Assists in the identification of priorities for the HRPP annual research compliance audit plan and conducts routine and targeted audits to assess compliance with institutional policies, GCP, and federal, state, and local regulations.
• Plans and executes internal audits and monitoring activities to support regulatory agency inspections.
• 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 closure activities.
• Prepares written audit and investigation reports summarizing observations, risk areas, trends, and recommended corrective and preventive actions (CAPAs).
• Reviews all corrective action plans for identified deficiencies and tracks the effectiveness of interventions for risk mitigation.
• Communicates findings to principal investigators, study teams, and institutional stakeholders, providing clear guidance on remediation steps and process improvements.
• Tracks and trends research compliance allegations, investigations, and outcomes.
• Serves as divisional subject matter expert regarding clinical research compliance.
• Provides training to faculty and staff to build knowledge of research compliance topics.
• 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; develops summary reports to support operational improvement efforts.
• Supports HRPP initiatives by trending, tracking, and setting targets to measure the impact of compliance activities.
• Collaborates with Clinical Research Stakeholders on cross-division projects focused on increasing efficiencies and risk mitigation.
• Provides support for ClinicalTrials.gov.
• 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.

Preferred Qualifications

Experience: 2-5 years of work experience in clinical research regulatory compliance, study coordination, quality assurance, monitoring, auditing, or related research activities. CITI Human Subject Protection & Good Clinical Practice experience strongly preferred. Advanced knowledge of regulations governing human research, including 21 CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR 46, and ICH Good Clinical Practice guidelines experience strongly preferred. Prior auditing, monitoring, or quality assurance experience strongly preferred. Familiarity with the ClinicalTrials.gov system strongly preferred. Experience with electronic IRB systems strongly preferred. Licenses and Certifications: Certification by one of the Clinical Research Professional Organizations (SQA, SOCRA, ACRP). Technical Skills or Knowledge: Proficiency with Microsoft Office applications including Word, Excel, PowerPoint, and Teams. Demonstrable organizational and project management skills. Experience with electronic IRB or clinical trial management systems.

Preferred Competencies

• Strong analytical, organizational, and report writing skills.
• Ability to evaluate research records and documentation for accuracy, completeness, and compliance.
• Ability to interpret research protocol information in relation to federal guidelines and internal policies; exercise sound judgment and make recommendations regarding research policies.
• Familiarity with large healthcare information systems and/or EPIC.
• Capacity to interpret research protocols, regulatory documentation, and institutional policies.
• Excellent interpersonal and communication skills (oral/written), including the ability to communicate findings effectively through written reports and presentations.
• Demonstrated attention to detail and ability to manage a high volume of work and meet deadlines.
• Ability to work as part of a collaborative team as well as autonomously.