Department

BSD CCC - Clinical Trials Office

About the Department

The University of Chicago Comprehensive Cancer Center (UCCCC) is an integral component of the Biological Sciences Division (BSD). The BSD is the largest of four Divisions of the University and includes the Pritzker School of Medicine. UCCCC administers four established scientific programs, and the NCI-sponsored Cancer Center Support Grant provides funding for ten Shared Resources. The Comprehensive Cancer Center is comprised of over 150 faculty members from twenty departments with members currently being awarded over $47 million in total direct costs in peer-reviewed cancer research grants, and $28 million in non-peer reviewed grants and contracts. The activities of the Center are broad and varied, including research, training and education, communications, fundraising, marketing, clinical trials management and community outreach.

UCCCC has one of the largest cancer clinical trials programs in the country and in the Chicago area with nearly 500 adult and pediatric therapeutic trials actively accruing patients. Many of these studies are investigator-initiated, including Phase I or I/II trials, demonstrating UCCCC commitment to translate basic research findings to the clinic through proof-of-principle and early phase studies. UCCCC opens over 250 new trials each year and accrues approximately 900 participants to therapeutic trials each year.

Job Summary

The job supervises and monitors a team of support 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.

The Assistant Regulatory Director (ARD) within the UCCCC Clinical Trials Support Office (CTSO) is responsible for the oversight of daily operations of the regulatory team to ensure that all cancer-focused clinical research is conducted in compliance with all application internal policies, federal regulations and guidelines.

Individual(s) in this role will provide expert guidance to PIs, research team, auditors, and other affiliated staff related to the maintenance of regulatory compliance for the conduct of clinical research activities.

Responsibilities

• Oversight of day-to-day operations of the cancer regulatory team in collaboration with the Regulatory Director and senior regulatory staff members to ensure compliance with all workflows, policies, regulations, and regulations governing the conduct of cancer clinical research; mentors new staff as required.

• Establishes and reinforces clear, measurable performance expectations under the direction of the Regulatory Director; oversee regulatory staff hiring and performance evaluation; implements and oversees staff performance improvement plans (as required).

• Oversee process for new investigator and research staff onboarding and essential document collection.

• Generates reports and monitors timeliness of regulatory activities including trial start-up, amendments, continuing reviews, and other required regulatory activities in collaboration with key stakeholders and departments.

• Identifies and evaluates fundamental issues pertaining to regulatory activities, proposes initiatives to address issues and barriers, and ensure solutions are implemented.

• Serves as a primary liaison representing the institution with regulatory federal and non-federal agencies during external audit; oversee preparation for external audits and regulatory monitoring activities; prepare and oversee implementation of corrective action plans and activities with input from Regulatory Director, senior team members, and other stakeholders as appropriate.

• Develops internal process documents, standard operating procedures, and training materials.

• Leads working groups and/or other internal committees.

• Develops and oversee regulatory staff training including implementation of new training programs in collaboration with senior regulatory staff and CTSO Education Manager.

• Ensures CTMS and other internal systems and databases are kept up to date; monitors compliance using dashboards/reports.

• Coordinates NCTN and other NCI-led group memberships in collaboration grant principal investigators and other stakeholders; ensure group rosters and related documentation are updated as part of UCCCC network growth activities; prepare and distribute reports related to these activities.

• Oversees IRB reliance activities in collaboration with internal and external stakeholders.

• Implements and leads the process for regulatory reviews, submissions, and regulatory trial master file maintenance for investigator-initiated protocols to ensure compliance with FDA regulations and requirements of funding sponsors.

• The ARD may also be responsible for the regulatory management for an assigned portfolio of clinical research projects including study start-up, amendments, continuing reviews, and related activities.

• Supervises the implementation of compliance activities designated by the University's strategic plans. Monitors University compliance with regulations and laws.

• Plans confidential counseling to those who feel they have experienced unlawful treatment based on University programs and activities.

• Performs other related work as needed.

Minimum Qualifications

Education:

Minimum requirements include a college or university degree in related field or an equivalent combination of education and experience.

---
Work Experience:

Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.

---
Certifications:

---

Preferred Qualifications

Education:

• Bachelor's Degree.

Experience:

• Minimum of 7 years of clinical trial or related experience.

• Knowledge of ICH and local regulatory authority drug research and development regulations.

• Experience with PC-Windows, word processing, and electronic spreadsheets.

• A minimum of 5 years clinical trials regulatory experience.

• Prior staff management experience.

• Familiarity with NCTN and related activities.

Working Conditions

• Hybrid work arrangements will be considered.

Application Documents

• Resume (required)

• Cover letter (preferred)

Job Family

Legal & Regulatory Affairs

Role Impact

People Manager

FLSA Status

Exempt

Pay Frequency

Monthly

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 and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, national or ethnic origin, age, status as an individual with a disability, military or 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.