Department
BSD CCC - Quality Core
About the Department
Job Summary
Responsibilities
Dedicates 25% of time to the management and support of Clinical Trials Monitors. Reviews monitoring reports and monitoring follow-up letters for quality checks.
Leads the development of educational programs for the Quality Unit team (Onboarding and continued education), 15% of time.
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 (approximately 50% of the time).
Helps ensure compliance of the clinical research enterprise with all related regulatory policies and guidelines, including federal, state, and local regulations, as well as the policies and procedures outlined by the Cancer Center.
Monitors 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.
Completes multiple projects at a time, and must have strong time management skills in addition to working both independently and in a team environment.
Ensures 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.
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.
Assists 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 meetings of the monitoring team.
Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.
Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a limited to moderate degree of independence. Contributes to the problem solving on assigned clinical research studies and tasks.
Performs other related work as needed.
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field.
Work Experience:
Certifications:
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Preferred Qualifications
Education:
Bachelor's Degree in a related field.
Experience:
Five or more years of progressive experience in clinical trials.
Three years of clinical trial monitoring experience, strongly preferred.
University or Academic medicine administrative experience.
Preferred Competencies
Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.
Strong organizational skills.
Excellent interpersonal skills.
Strong data management skills and attention to detail.
Knowledge of the Microsoft Suite, including Outlook.
Ability to understand complex documents (e.g., clinical trials).
Ability to handle competing demands with diplomacy and enthusiasm.
Ability to absorb large amounts of information quickly.
Adaptability to changing working situations and work assignments.
Working Conditions
Ability to navigate the UChicago Campus as required by the Position.
Hybrid work arrangements may be considered.
Application Documents
Resume (required)
Cover letter (preferred)
When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.
Job Family
Role Impact
Scheduled Weekly Hours
Drug Test Required
Health Screen Required
Motor Vehicle Record Inquiry Required
Pay Rate Type
FLSA Status
Pay Range
The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.
Benefits Eligible
The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.
Posting Statement
The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.
Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form.
All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.
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