Clinical Trials Auditor at University of Chicago in Chicago, Illinois

Posted in Other 13 days ago.





Job Description:

Department

BSD ALL - Audit


About the Department

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.


Job Summary

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 2 years of regulatory compliance experience and/or clinical 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 with clarity, 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 with minimal supervision.

  • Strong ability to work under pressure and coordinate multiple tasks.

  • Highly detail oriented. Requires ability to manage time, multi-task, problem solve and communicate effectively

Working Conditions

  • A minimum 30-40% travel is required to conduct Alliance audits and to Alliance Committee and Group Meetings.

Application Documents


  • Resume (required)

  • Cover Letter (preferred)


When applying, the document(s) MUSTbe uploaded via the My Experience page, in the section titled Resume/CV of the application.


Job Family

Legal & Regulatory Affairs


Role Impact

Individual Contributor


FLSA Status

Exempt


Pay Frequency


Scheduled Weekly Hours

40


Benefits Eligible

Yes


Drug Test Required

No


Health Screen Required

No


Motor Vehicle Record Inquiry Required

No


Posting Statement

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 Applicant Inquiry Form.

We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange.

All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.

The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at:http://securityreport.uchicago.edu.Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.