Job Description

Job Description:

• 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 Cancer Center.

• Assists 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.

• Ensures 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.

• Performs monitoring through a combination of remote data review and onsite monitoring visits (Hyde Park Campus); therefore, a willingness and ability to work remotely and in person is required.

• 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. 

• Ensures all Principal Investigator(s) and study teams adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures, including monitoring standards and guidelines.

• Adheres to the UCCCC Data Safety Monitoring Plan; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring related tools and templates. 

• Verifies 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.

• Assists in the development and writing of clinical trial monitoring plans.

• Participates in Cancer Center staff meetings.

• Provides recommendations and guidance to study specific monitoring teams and assist in audit readiness and preparation.

• Participates in regular monitoring team group meetings.

• Assists with various professional, organizational, and operational tasks under direct supervision.

• Supports quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.

• Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples.

• Performs other related work as needed.

Preferred Qualifications

Education:

• Bachelor's degree.

Experience:

• T hree years of Progressively responsible clinical trials experience.

• One year of m onitoring experience.

• University or Academic medicine administrative experience .

Working Conditions

• Ability to bend, crouch, or stoop.

• Ability to lift loads up tp 49lbs.

• Hybrid work arrangements will be considered.

Application Documents

• Resume (required)

• Cover letter (required)

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.

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: 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.

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.

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