Clinical Trials Monitor

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.

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.

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 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:
  
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• Education:
  
  Bachelor's degree.
• Experience (Clinical Trials): 3 years of progressively responsible clinical trials experience strongly preferred.
• Experience (Monitoring): 1 year of monitoring experience, strongly preferred.
• Experience (Administration): 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.

Office Environment. Hybrid work arrangements may be considered.

Resume (required) Cover letter…