The Regulatory Affairs Support Coordinator will coordinate and assist with activities related to the conduct of clinical research at the UCCCC, specifically with respect to the fulfillment of regulatory and administrative functions of the Cancer Clinical Trials Office (CCTO). The CCTO manages approximately 900 clinical trials at the University of Chicago, many of which are also being conducted at UCCCC network and affiliate institutions (approximately 40). This position will primarily focus on regulatory requirements, compliance, documentation thereof, and quality control for these studies.
Completing our mandatory reporting to the Clinical Trials Reporting Program (CTRP) and ClinicalTrials.gov including new trial registration, protocol updates, and accrual reporting;
Coordinating registration of over 350 investigators and clinical research staff in the NCIâ™s Registration and Credentialing Repository and acting as primary liaison with investigators, staff, and NCI for completion of these registrations;
Working with the Regulatory Affairs Managers to complete, process, update, and maintain regulatory documents for submission to the Institutional Review Board (IRB), Clinical Trials Review Committee (CTRC), Food and Drug Administration (FDA), external sponsors, and other institutional or external committees as required;
Maintaining appropriate databases/spreadsheets to support regulatory activities, such as management of Data and Safety Monitoring minutes for over 900 trials;
Collecting and tracking investigator and research personnel qualification and delegation of authority documentation (CVs, medical licensure, human subjects training, GCP training, etc.);
Coordinating and compiling materials for regulatory-related projects as needed (1572â™s, Financial Disclosures, etc.);
Assisting in the administration of quality control and quality assurance projects and procedures (internal audits, safety reporting, etc.) as required;
General office management (oversight of student workers, ordering supplies, coordinating meetings, delivering and picking-up mail/packages and site regulatory binders, filing, archiving, etc.).
Required: Excellent problem-solving skills/analytic and editing skills; Attention to detail and excellent
Excellent written and verbal communication skills
Ability to work independently and as part of a team
Ability to work with Microsoft Word and Excel
Preferred: Knowledge of relevant federal, state and local research compliance regulations
Preferred: Knowledge of database management software
Preferred: Familiarity with medical terminology and records
Education, Experience, and Certifications:
Bachelor's degree or a minimum of two years of relevant experience required.
Bachelor's degree in a relevant field preferred.
Administrative or project coordinator experience required.
One year of research regulatory compliance experience preferred.
Experience in clinical trials management and/or data collection preferred.
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 the Applicant Inquiry Form.
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Internal Number: JR00120
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