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　　BSD ALL - Audit

　　About the Department

　　The Alliance for Clinical Trials in Oncology is a member of the NCINational Clinical Trials Network (NCTN). The main goal of the NCTN is toconduct definitive, randomized, late phase clinical treatment trials andadvanced imaging trials across a broad range of diseases and diversepatient populations. The Alliance member network comprises nearly 10,000cancer specialists at over 1,000 hospitals, medical centers, andcommunity 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 theAlliance.

　　Job Summary

　　The Alliance for Clinical Trials in Oncology is a National ClinicalTrials Network (NCTN) sponsored by the National Cancer Institute (NCI)that consists of nearly 10,000 cancer specialists at over 1000hospitals, medical centers and community clinics across the UnitedStates and Canada. The Alliance at the University of Chicago serves asan operations office for development and management of Alliance NCTNclinical trials. This position maintains regulatory compliance programs,including the interpretation of systems to identify areas of risk andmay coordinate internal audits. With a moderate level of direction,participates in compliance documentation, compliance training, andcompliance committee formation.

　　The Clinical Trials Auditor will report to the Audit Program Directorand conduct Oncology clinical trials audits at Alliance sites. Inadherence to the Alliance audit policies and procedures, NCI ClinicalTrials Monitoring Branch (CTMB) Guidelines, and Alliance Audit SOPs,conducts assigned on-site audits of Alliance institutions in the areasof Institutional Review Board/Informed Consent Content (IRB/ICC),Pharmacy and Patient Case Review (PCR).

　　Responsibilities

　　Functions as the lead oncology clinical trials auditor onapproximately 25 - 30% of the audits.Writes audit reports and enters audit reports into the CTMB AuditInformation System. As necessary, assists with scheduling siteaudits and assisting volunteer auditors with logistical planning ofaudits.Evaluates institutional audit responses. Requests follow-up on anyinsufficient responses and evaluates any additional informationsubmitted.Advises oncology clinical trial sites regarding corrective actionplans for improvement of the institutional clinical trial program,including changes to the policies and procedures of the research andregulatory offices, institutional resources and responsibilities ofresearch personnel.Assists Audit Program Director to determine training needs forauditors and institutional personnel based on audit trends analysis.Develop and implement training programs for auditors andinstitutional personnel, including workshops, online trainingmodules, job aids and on-the-job training of new auditors.Ensure consistency of audit policy interpretation and application byall audit committee members and ad hoc auditors.Assists with review of regulatory compliance documents andparticipates in activities related to FDA inspection readiness forAlliance oncology registration trials.Review changes to local informed consent forms, including changes tothe risk sections. Respond to regulatory-related inquiries fromsites.Other duties as necessary to ensure compliance with the AllianceAudit P&P, Good Clinical Practice, CTMB Guidelines, andPharmaceutical Management Branch Guidelines.Plans and executes internal and external audits and activities tosupport regulatory agency inspections.repares, completes and submits all compliance documentation on aroutine basis. Coordinates compliance committee meetings.Performs other related work as needed.Minimum Qualifications

　　Education:

　　Minimum requirements include a college or university degree in relatedfield.

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　　Work Experience:

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

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　　Certifications:

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　　Preferred Qualifications

　　Experience:

　　A minimum 2 years of regulatory compliance experience and/orclinical trials monitoring/auditing.Four - five years of relevant clinical trials auditing experience.Nursing or other clinical experience.Preferred Competencies

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

　　Excellent oral and written communicate skills.

　　Excellent organizational and prioritization skills.

　　Ability to work effectively as part of a team and independently withminimal supervision.

　　Strong ability to