1) Completing our mandatory reporting to the Clinical Trials Reporting Program (CTRP) including new trial registration, protocol updates, and accrual reporting
2) Registering and maintaining records of our institutional clinical trials in clinicaltrials.gov
3) 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
4) Assisting Regulatory Affairs Managers with any aspect of protocol initiation and coordination
5) Maintaining appropriate databases/spreadsheets to support regulatory activities, such as management of Data and Safety Monitoring minutes for over 900 trials
6) Preparing and delivering regulatory binders for monitor visits by pharmaceutical representatives
7) Collecting and tracking investigator and research personnel qualification and delegation of authority documentation (CVs, medical licensure, human subjects training, GCP training, etc.)
8) Assisting in the administration of quality control and quality assurance projects and procedures (internal audits, safety reporting, etc.)
9) General office management (ordering supplies, coordinating meetings, delivering and picking-up mail/packages, filing, archiving, etc.)
10) Training and oversight of student workers
1) Excellent problem-solving skills/analytic and editing skills
2) Attention to detail and excellent organizational skills
3) Excellent written and verbal communication skills
4) Ability to work independently and as part of a team
5) Ability to work with Microsoft Word and Excel
6) Knowledge of relevant federal, state and local research compliance regulations
7) Knowledge of database management software
8) Familiarity with medical terminology and records
Preferred Qualifications Education 1) Bachelor's degree in a relevant field
Experience 1) Administrative or project coordinator experience 2) One year of research regulatory compliance experience 3) Experience in clinical trials management and/or date collection
Required Documents 1) Resume 2) Cover letter
NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application.
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: JR07905
About University of Chicago (UC)
One of the world's premier academic and research institutions, the University of Chicago has driven new ways of thinking since our 1890 founding. Today, UChicago is an intellectual destination that draws inspired scholars to our Hyde Park and international campuses, keeping UChicago at the nexus of ideas that challenge and change the world.