Research - Laboratory/Non-Laboratory, Staff/Administrative
Location: Hyde Park Campus
The Clinical Trials Monitor helps to ensure compliance of the clinical research enterprise with all related regulatory policies and guidelines, including federal, state, local, as well as the policies and procedures outlined by the Section of Hematology/Oncology. Under the direction of Clinical Trials Office Leadership, s/he will assist in the design, development, implementation, and conduct of an effective monitoring program in accordance with Good Clinical Practice, institutional policies and procedures, and research protocols. The Clinical Trials Monitor will ensure that, for those clinical trials assigned for monitoring, the appropriate and required monitoring tasks and related activities occur as outlined in the monitoring plan and in compliance with all related regulatory standards. Monitoring will be performed through a combination of remote data review and onsite monitoring visits; therefore, a willingness and ability to travel occasionally is required. The Clinical Trials Monitor is responsible for multiple projects at a time, and must have strong time management skills in addition to working both independently and in a team environment.
Ensure the Sponsor-Investigator and study team adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures, including DFCI CTO Monitoring standards and guidelines.
Adhere to the protocolsâ™ Data Safety Monitoring Plans; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring related tools and templates.
Monitor clinical trial progress through a combination of remote data review and on site monitoring visits. Some travel will be required.
Verify that trial data entered on the Case Report Form is consistent with patient clinical notes and other source documentation (source data verification).
Independently coordinate upcoming and ongoing monitoring assignments while meeting expected timelines for completion of monitoring activities and submission of written monitoring reports.
Assist in the development and writing of clinical trial monitoring plans.
Provide recommendations and guidance to study specific monitoring teams and assist in audit readiness and preparation.
Participate in regular monitoring team group meetings.
Ability to complete routine monitoring activities, monitoring reports, and effort trackers on time.
Ability to identify data discrepancies and/or instances of non-compliance and escalate appropriately.
Working understanding of DF/HCC SOPs and applicable federal and local regulations/policies.
Independently performs all primary duties listed above with minimal supervision.
Education, Experience or Certifications:
Bachelor's degree required.
Three years of progressively responsible clinical trials experience required.
One year of monitoring experience required.
University or Academic medicine administrative experience preferred.
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: JR04364
About University of Chicago
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.