Clinical Trials Auditor

Department
 

BSD ALL - Audit

About the Department
 

The Alliance for Clinical Trials in Oncology is a member of the NCI National Clinical Trials Network (NCTN). The main goal of the NCTN is to conduct definitive, randomized, late phase clinical treatment trials and advanced imaging trials across a broad range of diseases and diverse patient populations. The Alliance member network comprises nearly 10,000 cancer specialists at over 1,000 hospitals, medical centers, and community clinics across the United States and Canada. The Grant & Contract Specialist assists the Grants & Contract Administration, Specialist in managing the pre- and post-award fiscal activities of the Alliance.

Job Summary
 

The Alliance for Clinical Trials in Oncology is a National Clinical Trials Network (NCTN) sponsored by the National Cancer Institute (NCI) that consists of nearly 10,000 cancer specialists at over 1000 hospitals, medical centers and community clinics across the United States and Canada. The Alliance at the University of Chicago serves as an operations office for development and management of Alliance NCTN clinical trials. This position 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 Clinical Trials Auditor will report to the Audit Program Director and conduct Oncology clinical trials audits at Alliance sites. In adherence to the Alliance audit policies and procedures, NCI Clinical Trials Monitoring Branch (CTMB) Guidelines, and Alliance Audit SOPs, conducts assigned on-site audits of Alliance institutions in the areas of Institutional Review Board/Informed Consent Content (IRB/ICC), Pharmacy and Patient Case Review (PCR).

Responsibilities

• Functions as the lead oncology clinical trials auditor on approximately 25 - 30% of the audits.

• Writes audit reports and enters audit reports into the CTMB Audit Information System. As necessary, assists with scheduling site audits and assisting volunteer auditors with logistical planning of audits.

• Evaluates institutional audit responses. Requests follow-up on any insufficient responses and evaluates any additional information submitted.

• Advises oncology clinical trial sites regarding corrective action plans for improvement of the institutional clinical trial program, including changes to the policies and procedures of the research and regulatory offices, institutional resources and responsibilities of research personnel.

• Assists Audit Program Director to determine training needs for auditors and institutional personnel based on audit trends analysis. Develop and implement training programs for auditors and institutional personnel, including workshops, online training modules, job aids and on-the-job training of new auditors.

• Ensure consistency of audit policy interpretation and application by all audit committee members and ad hoc auditors.

• Assists with review of regulatory compliance documents and participates in activities related to FDA inspection readiness for Alliance oncology registration trials.

• Review changes to local informed consent forms, including changes to the risk sections. Respond to regulatory-related inquiries from sites.

• Other duties as necessary to ensure compliance with the Alliance Audit P&P, Good Clinical Practice, CTMB Guidelines, and Pharmaceutical Management Branch Guidelines.

• Plans and executes internal and external audits and activities to support regulatory agency inspections.

• 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.

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Work Experience:

Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications

Experience:

• A minimum two years of regulatory compliance experience and/or clinical trials monitoring/auditing.

• Four to five years of relevant clinical trials auditing experience.

• Nursing or other clinical experience.

Preferred Competencies

• Manage interpersonal relationships and interact/communicate with clarity, tact and courtesy with internal and external personnel. 

• Excellent oral and written communicate skills.