Clinical Trials Monitor

University of Chicago•Chicago, IL

2d•$65,000 - $80,000•Hybrid

About The Position

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.

Requirements

College or university degree in related field.
Knowledge and skills developed through 2-5 years of work experience in a related job discipline.
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.

Nice To Haves

Bachelor's degree.
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.

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.