Regulatory Compliance Specialist
Hyde Park Campus
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 5 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. The Regulatory Compliance Specialist will work in the Cancer Clinical Trials Office (CCTO), an existing centralized support office within the Cancer Center that provides services and high level guidance to individuals (faculty investigators, research staff, and clinic coordinators from the University and Hospital) involved in human subjects research. The CCTO is responsible for establishing standards, operating procedures, policies and practices, for coordinating system changes, implementing educational and training programs, developing communication tools, and managing the administrative functions that impact individuals involved in cancer clinical research.
This individual will have specialized detailed knowledge of regulatory requirements for conducting human subjects research; will be responsible for management and oversight of regulatory processes for specialized clinical research programs and projects; and will actively participate as a member of the research team in coordination, implementation and conduct of these studies. The research projects may involve multi-centered cooperative group studies, single site studies, industry studies, and investigator initiated studies that are submitted through the Cancer Center and implemented in Departments and Sections conducting cancer research. The Regulatory Compliance Specialist will be expected to participate in established and future research programs and will serve as primary regulatory liaison requiring interaction with principal investigators, co-investigators, internal review committees, affiliate institutions, sponsoring agents, the National Cancer Institute (NCI), the Food and Drug Administration (FDA), the Institutional Review Board (IRB), and other regulatory bodies.
The Regulatory Compliance Specialist will ensure the highest level of quality by keeping abreast of new guidelines, regulatory changes, policies and procedures to ensure that all guidelines (governmental as well as institutional) are met on a consistent basis.
- Regulatory Management: With respect to each research project, the work to be accomplished will be delineated by the processes and procedures defined by the University of Chicago's IRB and other regulatory agencies including the FDA, as well as study sponsor requirements.
- Industrial, Institutional and Federal Interface: Liaison between the Principal Investigator and external sponsor and funding source representatives to provide required regulatory documents and coordinate responses to the Institutional Review Committee (IRB) and external agencies (including NCI and the FDA).
- Quality Assurance/Quality Control: The Regulatory Compliance Specialist will implement quality control procedures for review and preparation of accurate regulatory documents for submission to the Institutional Review Board (IRB), the Clinical Trials Review Committee (CTRC), NCI, FDA, and other external sponsors.
- Good understanding of clinical trials management systems' main features, study management, patient management. Solid knowledge and experience on Clinical Trials regulatory policies. Experience in NCI, and other federal agencies, reporting policies.
- Good computer, documentation, organization, and interpretational skills required.
- Excellent written and interpersonal skills required. Ability to effectively present oral and written information required.
- Analytical, problem solving, and decision making skills required. Attention to detail required.
- Ability to multitask required. Good interpersonal skills and ability to work independently and as part of a team required.
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. Employment will be contingent upon the continued receipt of these extramural funds and satisfactory job performance. If the position is eliminated due to the discontinuation of extramural funding, a minimum of one pay period's written notice (one month) will be given or pay in-lieu of notice.
Education, Experience or Certifications:
Required – Bachelor's degree or a combination of education and related experience required (one year of education equals one year of experience).
Preferred – Bachelor's degree in a health related or relevant field preferred. Certification in clinical trials management preferred. Human subjects training preferred.
Required - A minimum of one year of clinical research compliance or directly related experience required.
Preferred – Two years of clinical research compliance or directly related experience preferred.
NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application.
Depends on Qualification
Scheduled Weekly Hours
Job is Exempt?
Drug Test Required?
Does this position require incumbent to operate a vehicle on the job?
Health Screen Required?
Remove from Posting On or Before
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.
The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: http://securityreport.uchicago.edu. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.
The University of Chicago is an urban research university that has driven new ways of thinking since 1890. Our commitment to free and open inquiry draws inspired scholars to our global campuses, where ideas are born that challenge and change the world.
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.
To learn more about the university click here http://www.uchicago.edu/