Sr. Clinical Trials Monitor

* 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.
* 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.
* 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.
* Ability to navigate the UChicago Campus as required by the Position.
* Hybrid work arrangements may be considered.

When applying, the document(s)
** MUST
* * be uploaded via the
** My Experience
** page, in the section titled
** Application Documents
** of the application.

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