Clinical Trials Monitor

University of Chicago; Chicago (IL); Hybrid; USD 65,000 - 80,000; Full time

Job summary

The University of Chicago Medicine Comprehensive Cancer Center is seeking a Clinical Research Monitoring Specialist to manage and support daily clinical research and trial activities. You will collect, document, analyze, and report data while ensuring compliance with FDA, ICH/GCP, and local policies.

Hybrid work arrangements may be considered. Candidates should have a related degree and 2–5 years of clinical trials experience, with strong organizational and communication skills.

Qualifications

• Must have a college or university degree in a related field.
• 2–5 years of experience in a clinical trials related role.
• Strong knowledge of regulatory requirements (FDA, ICH/GCP).

Responsibilities

• Manage, facilitate, and monitor daily clinical research and clinical trial activities.
• Collect, document, analyze, and report clinical research data.
• Ensure compliance with federal, state, local regulations and Center policies.
• Coordinate monitoring tasks and prepare monitoring reports and plans.
• Support protocol start-up activities and audit readiness.

Skills

Organizational skills

Interpersonal skills

Data management

Attention to detail

Communication

Team collaboration

Education

Bachelor's degree

College/university degree

Tools

Microsoft Office

Job description

About The Department

Department

BSD CCC - Quality Core

About The Department

The University of Chicago Medicine Comprehensive Cancer Center (UCCCC) is an integral component of the Biological Sciences Division (BSD). The BSD is the largest of four Divisions of the University and includes the Pritzker School of Medicine. UCCCC administers four established scientific programs, and the NCI-sponsored Cancer Center Support Grant funds ten Shared Resources. The Comprehensive Cancer Center comprises over 200 faculty members from twenty departments, with members currently being awarded over $51million in total direct costs in peer-reviewed cancer research grants, and $24 million in non-peer-reviewed grants and contracts. The activities of the Center are broad and varied, including research, training and education, marketing and communications, fundraising, data analytics, clinical trials management, and community outreach and engagement. The UCCCC has one of the largest cancer clinical trials programs in the country and in the Chicago area, with more than 450 adult and pediatric therapeutic trials actively accruing patients. Many of these studies are investigator-initiated, including Phase I or I/II trials, demonstrating UCCCC's commitment to translating basic research findings to the clinic through proof-of-principle and early-phase studies. UCCCC opens over 130 new trials each year and accrues approximately 800 participants to therapeutic trials each year.

Job Summary

Manages, facilitates, and monitors daily clinical research and clinical trial activities. Performs a variety of duties involved in the collection, documentation, analysis, and reporting of clinical research and clinical trial data. The job compiles, documents, analyzes, and reports on moderately complex clinical studies. Provides input to support the administrative and operational decisions that impact clinical research conducted across the University.

Responsibilities

• Ensures compliance of clinical research, which includes compliance with federal, state, and local regulations, and University of Chicago Comprehensive Cancer Center regulations and policies.
• Administers the required monitoring tasks, as outlined in the monitoring plan, in compliance with all applicable regulations.
• 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.
• 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 Investigators 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.
• Supports protocol start-up activities.
• Independently coordinates 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.
• Provides recommendations and guidance to study specific monitoring teams and assists in audit readiness and preparation.
• Accountable for all tasks in moderately complex clinical studies.
• Assists with various professional, organizational, and operational tasks under moderate supervision.
• Performs other related work as needed.

Education

Minimum Qualifications

Minimum requirements include a college or university degree in related field.

Work Experience

Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

Certifications

Preferred Qualifications

Education

• Bachelor's degree.

Experience

• 3 years of progressively responsible clinical trials experience strongly preferred.
• 1 year of monitoring experience, strongly preferred.
• 5 years of University or Academic medicine administrative experience strongly preferred.

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

• Office Environment.
• Hybrid work arrangements may be considered.

Application Documents

• Resume (required)
• Cover letter (preferred)

Job Family

Research

Role Impact

Individual Contributor

Scheduled Weekly Hours

40

Drug Test Required

No

Health Screen Required

No

Motor Vehicle Record Inquiry Required

No

Pay Rate Type

Salary

FLSA Status

Exempt

Pay Range

$65,000.00 - $80,000.00

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

Yes

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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