Director Of Quality Assurance And Audit Program

University Of Chicago Chicago , IL 60602

Posted 2 months ago

Please make sure to read the job posting in its entirety as it reflects both the University roles and responsibilities, followed by the specific description.

Department
2010050 BSD - Alliance Clin Trials In Onc

About the Unit

The Alliance for Clinical Trials in Oncology is a clinical trials network sponsored by the National Cancer Institute that consists of nearly 10,000 cancer specialists at over 1000 member hospitals, medical centers and community sites across the United States and Canada. The Alliance develops and conducts clinical trials with promising new cancer therapies, and utilizes the best science to develop optimal treatment and prevention strategies for cancer, as well as researches methods to alleviate side effects of cancer and cancer treatments.

Job Family

Legal & Regulatory Affairs

Responsible for providing advice and services to University officials on legal issues associated with the University's activities, including transactional and intellectual property matters, policy formulation and compliance, employment and student issues, and pre-litigation dispute resolution. Represents the University's interests in administrative and judicial proceedings. Holds primary institutional responsibility for establishing and maintaining relationships with regulatory and other governmental entities, and establishing and maintaining related compliance policies and protocols.

Career Track and Job Level

Compliance & Internal Audit

Directs the operations of regulatory compliance programs. Develops systems to identify areas of risk and initiates internal audits. Directs compliance documentation submission and maintenance, compliance training, compliance committee formation, and other programmatic functions.

M2: Manages professional employees and/or supervisors. Is accountable for the performance and results of a team within own discipline. Adapts departmental plans and priorities to address resource and operational challenges. Decisions are guided by policies, procedures and business plan; receives guidance from manager. Provides technical guidance to employees, colleagues and/or customers.

Role Impact

People Manager

Responsibilities

The job manages a team of professional staff responsible for regulatory compliance program activities. Anticipates problems and develops systems to identify areas of risk through internal audits. Uses specialized expertise to manage compliance documentation submission and maintenance, compliance training, compliance committee formation, and other programmatic functions.

  1. Manages the implementation of compliance activities designated by the University's strategic plans. Monitors University compliance with regulations and laws., 2) Ensures teams develop and administer policies related to affirmative action, non-discriminatory practices for persons with disabilities, and unlawful harassment or sexual misconduct., 3) Manages confidential counseling to those who feel they have experienced unlawful treatment based on University programs and activities., 4) Represents the University in regulatory proceedings before federal, state and local agencies. Prepares the University's position statements and responses to information requests. Manages audit responses and negotiations with administrative agencies., 5) Performs other related work as needed.

Unit-specific Responsibilities

  1. Directs the operations of Quality Assurance, including regulatory and FDA compliance, and the audit operations for The Alliance for Clinical Trials in Oncology (Alliance).
  2. Develops and maintains P&Ps and SOPs for the Alliance Audit Program based on requirements and guidelines from the Clinical Trials Management Branch (CTMB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis, National Cancer Institute (NIH), the FDA, Clinical Trials Support Unit (CTSU, and the Office of Human Research Protection (OHRP).
  3. Manages, trains, and evaluates the Alliance audit staff for audit scheduling, audit functions, and audit report submissions to the CTMB.
  4. Serves as a liaison between Alliance and the CTMB, CTSU, and CTEP which often requires national committee participation.
  5. Conducts on-site audits according to CTMB and CTEP Guidelines and Alliance P&Ps and creates audit reports for such audits when acting as the audit team leader.
  6. Reviews all draft and final Alliance audit reports nation-wide, along with applicable international sites.
  7. Oversees institutional audit responses and corrective plans. Mentors sites with critical areas from audit findings as well as assesses audit trends and determines needs for strategic planning and/or site and auditor training.
  8. Directs the activities as well as leads Audit Committee meetings at bi-annual group meeting.
  9. Assesses registration trial findings and trends as well as participates in registration trials and QA meetings to identify areas of risk, protocol violations and non-compliance.

Unit-preferred Competencies

  1. Strategic Leadership and interpersonal skills
  2. Strong oral and written communication skills
  3. Strong Organizational and Analytical skills
  4. Strong Project Management and Prioritization skills
  5. Ability to work independently as well as part of a team

Working Conditions

  1. Minimum of 10-15% audit and meeting travel is required. Travel to NCI meetings may be needed.

Education, Experience, and Certifications

Minimum requirements include a college or university degree in related field.

Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline.

Preferred Qualifications

Education
1)Bachelors degree.
2) Masters degree.

Experience

  1. Minimum of 2 years clinical trials monitoring/auditing.
    2)Minimum of five (5) years clinical trials management, quality assurance and/or regulatory affairs experience.
  2. Minimum of 2-5 supervisory experience.
  3. Significant knowledge of relevant federal compliance laws and regulations.
  4. Maintain active Human Subjects and Good Clinical Practice Certificates.

Required Documents

  1. Resume

NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application

FLSA Status

Exempt

Pay Frequency

Pay Grade

Depends on Qualifications

Scheduled Weekly Hours
40

Benefits Eligible

Yes

Drug Test Required

No

Health Screen Required

No

Motor Vehicle Record Inquiry Required

No

Posting Date
2019-09-06-07:00

Remove from Posting On or Before
2020-03-06-08:00

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.

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.


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Director Of Quality Assurance And Audit Program

University Of Chicago