Reg 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 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. 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.
The individual will be responsible for management and oversight of regulatory processes throughout the clinical trial life cycle for clinical research programs and projects submitted through the Cancer Center. This individual will serve as a subject-matter expert on issues related to clinical trials regulations, humans subjects protection and Good Clinical Practice.
Protocol Regulatory Management:
- Responsible for the following as defined by the University of Chicago's policies, Code of Federal Regulations, Good Clinical Practice and other applicable policies and/or regulations.
- Preparation and collection of all necessary documents to activate protocols (e.g. consent forms, Form FDA 1572, etc)
- Preparation and submission to the IRB and other applicable internal review committees including submission of new study applications, amendments, and continuing reviews.
- Creation and maintenance of site regulatory files for each assigned study.
- Communication of updates and changes (e.g. protocol amendments) to the clinical research team and sponsor/funding agencies.
Multi-site Regulatory Coordination:
- 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.)
- Preparation of protocol updates and coordination of weekly program meetings and distribution of relevant updates to participating sites.
- Maintenance of up-to-date regulatory files for external participating sites.
- Solid understanding of regulations covering clinical trials/human subjects research.
- Excellent written and interpersonal skills required. Ability to effectively present oral and written information.
- Analytical, problem solving, and decision making skills.
- Attention to detail.
- Ability to multitask.
- Good interpersonal skills and ability to work independently and as part of a team.
- Excellent computer skills, including familiarity with Microsoft Office (Word, Excel, Outlook) and Adobe Acrobat. Familiarity with clinical trial management systems and/or databases preferred.
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).
- Required – A minimum of one year of clinical research or directly related experience required.
- Preferred – Two years of clinical research or directly related experience preferred
- Preferred – Prior clinical trial regulatory experience preferred.
- Preferred – Completion of a certificate or degree program in clinical trial management /regulatory affairs (or directly related field).
- 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
Job is Exempt?
Drug Test Required?
Does this position require incumbent to operate a vehicle on the job?
Health Screen Required?
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