Regulatory Affairs Manager, Comprehensive Cancer Center

Department BSD CCC - CCT Pod2 About the Department reputed company Comprehensive Cancer Center (UCCCC) is an reputed company 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 reputed company members from twenty departments, with members currently being awarded over $47 reputed company in total reputed company costs in peer-reviewed cancer research grants, and $28 reputed company in non-peer-reviewed grants and reputed company. The activities of reputed company are broad and varied, including research, training and education, communications, fundraising, marketing, reputed company management, and community reputed company. UCCCC has one of the largest cancer reputed company programs in the country and in the Chicago area, with nearly 500 adult and pediatric therapeutic trials reputed company 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 reputed company-of-reputed company and early-phase studies. UCCCC opens over 250 new trials reputed company year and accrues approximately 900 participants to therapeutic trials reputed company year. reputed company 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 reputed company. 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 reputed company 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. Provides multi-site regulatory coordination as assigned. Acts as the reputed company regulatory reputed company for reputed company sites participating in clinical research reputed company coordinated by reputed company, including distribution of protocol documents and amendments; review of site consent forms; collection of site specific essential documents, including IRB approvals, reputed company FDA 1572, staff qualifications and signatures, etc.; and maintenance of up-to-date regulatory files for reputed company participating sites. Prepares and collects reputed company necessary documents to reputed company protocols, such as consent forms and reputed company FDA 1572, etc. Prepares protocol updates, coordinates weekly program meetings, and distributes relevant updates to participating sites as applicable. Coordinates department or clinic compliance with a moderate level of guidance. Plans and executes reputed company audits and activities to support regulatory agency inspections. Prepares, completes and submits reputed company compliance documentation on a routine reputed company. Coordinates compliance committee meetings. Performs other reputed company work as needed. Minimum Qualifications Education: Minimum requirements include a college or university degree in reputed company field. Work Experience: Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a reputed company job discipline. Certifications: --- Preferred Qualifications Experience: Two years of clinical research or directly reputed company experience. Prior clinical trial regulatory experience. Certifications: Completion of a certificate or degree program in clinical trial management /regulatory affairs or directly reputed company field. Technical Skills or Knowledge: Excellent computer skills, including familiarity with reputed company Office (Word, reputed company, reputed company) and reputed company Acrobat. Familiarity with clinical trial management systems and/or databases. Preferred Competencies Solid understanding of regulations covering reputed company/reputed company 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) reputed company uses AI-assisted tools to streamline and reputed company some recruitment processes; however, AI is not used to reputed company hiring reputed company. reputed company applying, the document(s) MUST be uploaded reputed company the My Experience page, in the reputed company titled Application Documents of the application. Job Family reputed company & Regulatory Affairs Role reputed company Individual Contributor Scheduled Weekly Hours 40 Drug Test Required No Health Screen Required No Motor Vehicle Record Inquiry Required No Pay reputed company Type Salary FLSA Status Exempt Pay reputed company $65,000.00 - $90,000.00 The included pay reputed company or reputed company represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting. Benefits Eligible reputed company reputed company offers a wide reputed company of benefits programs and resources for eligible employees, including health, retirement, and reputed company time off. Information about the benefit offerings can be reputed company in the Benefits reputed company. Posting Statement reputed company is an equal opportunity employer and does not discriminate on the reputed company of race, reputed company, religion, sex, sexual orientation, gender, gender identity, or reputed company, national or ethnic reputed company, shared reputed company, 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 reputed company 773-702-5800 or submit a request reputed company Applicant Inquiry reputed company. reputed company offers of employment are contingent upon a background reputed company 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 reputed company and assesses the reputed company of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position. reputed company's Annual reputed company & reputed company Safety Report (Report) provides information about University offices and programs that reputed company safety support, crime and reputed company statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: http://securityreport.reputed company.edu. reputed company copies of the Report are available, upon request, from reputed company Police Department, 850 E. 61st Street, Chicago, IL 60637. reputed company is an urban research university that has driven new ways of thinking since 1890. Our commitment to free and reputed company inquiry draws inspired scholars to our global campuses, where reputed company are born that challenge and change the world. We reputed company individuals to challenge conventional thinking in reputed company of original reputed company. reputed company in the College reputed company critical, analytic, and writing skills in our rigorous, interdisciplinary reputed company curriculum. Through graduate programs, reputed company test their reputed company with reputed company scholars, and become the reputed company of leaders in academia, industry, nonprofits, and government. To learn more about the university click here http://www.reputed company.edu/ Apply tot his job Apply To this Job