Regulatory Compliance Specialist-1
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2010010 BSD Comprehensive Cancer Center
About the Unit
The University of Chicago Medicine Comprehensive Cancer Center (UCCCC) is an integral component of the University of Chicago Medicine and the Biological Sciences Division (BSD), the largest of four Divisions of the University that also includes the Pritzker School of Medicine. The UCCCC administers 6 established scientific programs, and the Cancer Center Support Grant from the National Cancer Institute provides funding for 11 Shared Facilities. The Center comprises over 215 faculty members from over 20 departments, with members being awarded over $60 million Direct Costs in peer-reviewed cancer research grants, and $17 million in non-peer reviewed grants and contracts. The activities of the Center are broad and varied including research, patient education and support, fundraising, marketing, clinical trials management, community outreach, and grant administration. The UCCCC facilitates interactions between laboratory, clinical and population scientists to foster discovery and its translation into direct benefit to patients and the general public. The Cancer Center has an extremely active clinical trials research program with over 900 clinical trials, many of which are also conducted at UCCCC affiliate institutions (approximately 40). Community researchers also strive to eliminate health disparities among ethnic or social groups. This at-will position is wholly or partially funded by extramural funds (e.g., grant, gift, endowment) which are renewed under provisions set by the grantor. This employment will be contingent upon the continued receipt of these extramural funds and your satisfactory job performance. If this position is eliminated due to the discontinuation of extramural funding, a minimum of one pay period’s written notice (If exempt: 30 days, If non-exempt: 2 weeks), will be given or pay in-lieu of notice.
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.
P2: Requires knowledge and experience in own discipline; still acquiring higher-level knowledge and skills. Builds knowledge of the organization, processes and customers. Solves a range of straightforward problems. Analyzes possible solutions using standard procedures. Receives a moderate level of guidance and direction.
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.
1) Coordinates department or clinic compliance with a moderate level of guidance., 2) Plans and executes internal and external audits and activities to support regulatory agency inspections., 3) Prepares, completes and submits all compliance documentation on a routine basis. Coordinates compliance committee meetings., 4) Performs other related work as needed.
1) Preparation and collection of all necessary documents to activate protocols (e.g. consent forms, Form FDA 1572, etc.)
2 ) Preparation and submission to the IRB and other applicable internal review committees including submission of new study applications, amendments, and continuing reviews
3) Creation and maintenance of site regulatory files for each assigned study
4) Communication of updates and changes (e.g. protocol amendments) to the clinical research team and sponsor/funding agencies
5) Participation in internal clinical research audit program (as assigned)
6) Multi-site Regulatory Coordination (as assigned):Act 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.), maintenance of up-to-date regulatory files for external participating sites.
7) Preparation of protocol updates and coordination of weekly program meetings and distribution of relevant updates to participating sites (as applicable).
1) Solid understanding of regulations covering clinical trials/human subjects research
2) Excellent computer skills, including familiarity with Microsoft Office (Word, Excel, Outlook) and Adobe Acrobat
3) Familiarity with clinical trial management systems and/or databases
4) Excellent written and interpersonal skills. Ability to effectively present oral and written information
5) Analytical, problem solving, and decision making skills
6) Attention to detail
7) Ability to multitask
8) Good interpersonal skills and ability to work independently and as part of a team
Education, Experience, and Certifications
Minimum requirements include a college or university degree in related field.
Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.
1) Two years of clinical research or directly related experience
2) Prior clinical trial regulatory experience
3) Completion of a certificate or degree program in clinical trial management /regulatory affairs (or directly related field)
2) Cover Letter
NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application.
Depends on Qualifications
Scheduled Weekly Hours
Drug Test Required
Health Screen Required
Motor Vehicle Record Inquiry Required
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.
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We empower individuals to challenge conventional thinking in pursuit of original ideas. Students in the College develop critical, analytic, and writing skills in our rigorous, interdisciplinary core curriculum. Through graduate programs, students test their ideas with UChicago scholars, and become the next generation of leaders in academia, industry, nonprofits, and government.
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Job posted: 2020-07-13