Regulatory Affairs Manager 1

Department

BSD CCC - CCT Pod2

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 190 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

This at-will position is wholly or partially funded by extramural funds (e.g., grant, gift, endowment) which is renewed under provisions set by the grantor. This employment will be contingent upon the continued receipt of these extramural funds and satisfactory job performance. If this position is eliminated due to the discontinuation of extramural funding, a minimum of one pay period written notice will be given. If exempt: 30 days, If non-exempt: 2 weeks, or pay in-lieu of notice.

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.

Responsibilities

• Prepares and submits new study applications, amendments, and continuing reviews, to the IRB and other applicable internal review committees.

• Creates and maintains site regulatory files for each assigned study.

• Communicates updates and changes, e.g. protocol amendments, to the clinical research team and sponsor/funding agencies.

• Participates in internal clinical research audit program as assigned.

• Multi-site regulatory coordination as assigned. Acts as the primary regulatory liaison for external sites participating in clinical research projects coordinated by the University of Chicago, including distribution of protocol documents and amendments, review of site consent forms, collection of site specific essential documents (IRB approvals, Form FDA 1572, staff qualifications and signatures, etc.), and maintenance of up-to-date regulatory files for external participating sites.

• Prepares and collects all necessary documents to activate protocols, e.g. consent forms, Form FDA 1572, etc.

• Prepares protocol updates, coordinates weekly program meetings, distributes relevant updates to participating sites as applicable.

• Coordinates department or clinic compliance with a moderate level of guidance.

• 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

Education:

• Completion of a certificate or degree program in clinical trial management /regulatory affairs or directly related field.

Experience:

• Clinical research or directly related experience.

• Prior clinical trial regulatory experience.

Technical Skills or Knowledge:

• Solid understanding of regulations covering clinical trials/human subjects research.

• Excellent computer skills, including familiarity with Microsoft Office (Word, Excel, Outlook) and Adobe Acrobat.

• Familiarity with clinical trial management systems and/or databases.

Preferred Competencies

• Excellent written and interpersonal skills.

• Effectively present oral and written information.

• Analytical, problem solving, and decision making skills.

Application Documents

• Resume/CV (required)
• Cover Letter (preferred)

When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.

Job Family

Legal & Regulatory Affairs

Role Impact

Individual Contributor

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.

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