Regulatory Affairs Manager, Comprehensive Cancer Center

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 funds ten Shared Resources. The Comprehensive Cancer Center comprises 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's commitment to translating 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 position maintains clinical trial 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 submission of documentation to required internal committees and groups.

Responsibilities

• Prepares and submits materials to the IRB and other applicable internal review committees, including new study applications, amendments, and continuing reviews.
• Creates and maintains the site of regulatory files for each assigned study.
• Communicates updates and changes, such as protocol amendments, to the clinical research team and sponsor/funding agencies.
• Participates in internal clinical research audit program 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, including 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, such as consent forms and Form FDA 1572, etc.
• Prepares protocol updates, coordinates weekly program meetings, and distributes relevant updates to participating sites as applicable.
• Plays a role in planning and executing internal and external audits and activities to support regulatory agency inspections.
• Prepares, completes and submits all compliance documentation on a routine basis.
• Captures and coordinates compliance committee meetings.
• Performs other related work as needed.

Education

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

Work Experience

• Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

Preferred Qualifications

• Experience: Two years of clinical research or directly related experience.
• Prior clinical trial regulatory experience.

Technical Skills

• 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

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

Pay Range

$65,000.00 - $90,000.00

Benefits Eligible

Yes

Posting Statement

The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, 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.