Sr. Clinical Trials Monitor

Department

BSD CCC - Quality Core

About the Department

The University of Chicago 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 190 faculty members from twenty departments, with members currently being awarded over $47 million in total direct costs in peer-reviewed cancer research grants, and $28 million in non-peer-reviewed grants and contracts. The activities of the Center are broad and varied, including research, training and education, communications, fundraising, marketing, clinical trials management, and community outreach.

UCCCC has one of the largest cancer clinical trials programs in the country and in the Chicago area, with nearly 500 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 250 new trials each year and accrues approximately 900 participants to therapeutic trials each year.

Job Summary

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.

Manages, facilitates, and monitors daily activities related to clinical research and clinical trials. Performs a variety of duties involved in the collection, documentation, analysis, and reporting of clinical research and clinical trial data.

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