Biological Sciences Division at the University of Chicago
Regulatory Affairs Manager
Biological Sciences Division at the University of Chicago, Chicago, Illinois, United States, 60290
Overview
Base pay range: $65,000.00/yr - $90,000.00/yr. This range is provided by Biological Sciences Division at the University of Chicago. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. 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 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 The job 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 to the IRB and other applicable internal review committees, including submission of new study applications, amendments, and continuing reviews. 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 the 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, and 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 and coordinates weekly program meetings and distribution of 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. Qualifications
Education Minimum qualifications 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. Certifications Preferred Qualifications 4+ years of prior work experience in clinical research and regulatory compliance. Advanced degree or certification in clinical research or related field. Clinical research certification (SOCRA, ACRP, etc.). Demonstrated familiarity with federal and international regulations governing the oversight and conduct of clinical research. Strong oral and written communication skills with both teams, faculty, and external vendors and sponsors. Project management experience. Preferred Competencies
Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others. Strong organizational skills. Excellent interpersonal skills. Strong data management skills and attention to detail. Knowledge of the Microsoft Suite, including Outlook. Ability to understand complex documents (e.g., clinical trials). Ability to handle competing demands with diplomacy and enthusiasm. Ability to absorb large amounts of information quickly. Adaptability to changing working situations and work assignments. Working Conditions
Ability to navigate the UChicago Campus as required by the Position. Hybrid work arrangements may be considered. Application Documents
Resume (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 Details
Job Family: Legal & Regulatory Affairs Role Impact: Individual Contributor Scheduled Weekly Hours: 40 Drug Test Required: No Health Screen Required: No Motor Vehicle Record Inquiry Required: No Pay Rate Type: Salary FLSA Status: Exempt Pay Range: $65,000.00 - $90,000.00 The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting. Benefits Eligible: Yes The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook. Disclosures
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. 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. 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. The University of Chicago’s Annual Security & Fire Safety Report provides information about safety support, crime and fire statistics, emergency response and policies. The Report can be accessed online at: securityreport.uchicago.edu. Posting statements and related content, including referrals and additional job notices, are not required to be shown in this refined description.
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Base pay range: $65,000.00/yr - $90,000.00/yr. This range is provided by Biological Sciences Division at the University of Chicago. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. 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 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 The job 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 to the IRB and other applicable internal review committees, including submission of new study applications, amendments, and continuing reviews. 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 the 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, and 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 and coordinates weekly program meetings and distribution of 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. Qualifications
Education Minimum qualifications 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. Certifications Preferred Qualifications 4+ years of prior work experience in clinical research and regulatory compliance. Advanced degree or certification in clinical research or related field. Clinical research certification (SOCRA, ACRP, etc.). Demonstrated familiarity with federal and international regulations governing the oversight and conduct of clinical research. Strong oral and written communication skills with both teams, faculty, and external vendors and sponsors. Project management experience. Preferred Competencies
Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others. Strong organizational skills. Excellent interpersonal skills. Strong data management skills and attention to detail. Knowledge of the Microsoft Suite, including Outlook. Ability to understand complex documents (e.g., clinical trials). Ability to handle competing demands with diplomacy and enthusiasm. Ability to absorb large amounts of information quickly. Adaptability to changing working situations and work assignments. Working Conditions
Ability to navigate the UChicago Campus as required by the Position. Hybrid work arrangements may be considered. Application Documents
Resume (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 Details
Job Family: Legal & Regulatory Affairs Role Impact: Individual Contributor Scheduled Weekly Hours: 40 Drug Test Required: No Health Screen Required: No Motor Vehicle Record Inquiry Required: No Pay Rate Type: Salary FLSA Status: Exempt Pay Range: $65,000.00 - $90,000.00 The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting. Benefits Eligible: Yes The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook. Disclosures
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. 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. 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. The University of Chicago’s Annual Security & Fire Safety Report provides information about safety support, crime and fire statistics, emergency response and policies. The Report can be accessed online at: securityreport.uchicago.edu. Posting statements and related content, including referrals and additional job notices, are not required to be shown in this refined description.
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