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Job Description:

• Perform comprehensive audits of clinical research protocols.

• Take necessary steps to prepare for audit such as thoroughly reading and understanding assigned protocol, federal regulations, Good Clinical Practice guidelines, and UCCCC standard operating policies.

• Conduct regulatory document and pharmacy review for the selected protocol.

• Conduct audit of selected participantâ™s source documentation including review of the electronic medical record, research files, labs etc.

• Coordinate logistics of audit and troubleshoot any problems that arise, such as access the electronic medical records.

• Summarize and present audit findings to the overall Principal Investigator (PI), local PIs, and study staff during  the  audit exit interview.

• Analyze audit findings to appropriately assign major or minor violations, provide an overall rating of the audit, and draft a Final Audit Report for review and approval by the Data & Safety Monitoring Committee.

• Issue final audit report and review the study teamâ™s audit response and Corrective Plan and Preventative Plans to ensure they appropriately address the findings in the final audit report.

• Maintain data on auditing activities in the UCCCC CTMS.

• Acts as a resource on the basics of clinical research and related aspects of clinical study for colleagues with less experience. Prepares and evaluates writing protocols, IRB submissions, grant applications, manuscripts, reports, and dissemination tools.

• Implements Good Clinical Practices (GCP) and all relevant current local, state, and federal laws, regulations, policies and procedures. Develops and implements consistent standards and protocols.

• Performs other related work as needed.

Preferred Qualifications

Education:

• Bachelors.

Experience:

• Clinical trial coordination or clinical research monitoring.

• Previous audit experience.

• Familiarity with NCTN and National Cancer Institute trials and standard operating procedures strongly preferred.

Licenses and Certifications:

• Clinical Research Certification strongly preferred.

Technical Skills or Knowledge:

• Expertise in Microsoft Excel, Access, and PowerPoint.

Preferred Competencies

• Strong analytical, organizational and report writing skills.

• Excellent interpersonal and communication skills (oral/written).

• Knowledge of regulations governing human research.

• Ability to work as part of collaborative team as well as autonomously.

• Demonstrable organizational and project management skills.

Application Documents

• Resume (required)

• Cover letter (preferred)

The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, status as an individual with a disability, protected veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.

Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via the Applicant Inquiry Form.

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