University of Chicago · 3 months ago
Clinical Research Manager, Research Incubation Unit
Chicago, IL
Full-time
Onsite
Mid, Senior Level
$90K/yr - $130K/yr
7+ years expThe University of Chicago is a leading institution in clinical research, and they are seeking a Clinical Research Manager for their Research Incubation Unit. The role involves managing a team responsible for clinical research conduct, participant management, data management, and regulatory compliance, while also overseeing the growth of clinical research portfolios across the Biological Sciences Division.
Higher Education
Responsibilities
Oversee Departmental Clinical Research Portfolio across the lifecycle for each protocol from feasibility, startup, recruitment, day-to-day conduct, follow up through study close out
Coordinate departmental clinical research staff and faculty meetings
Oversee the conduct of clinical research, regulatory compliance, and IRB filings for all projects in the departmental portfolio
Establish documentation standards for departmental scientific review and feasibility for all proposed clinical research projects
Establish departmental standard work and standard operating procedures
Monthly Reports of site performance and percent effort reports
Training and onboarding of all research staff in GCP, 21 CFR 11, 21 CFR 312, 21 CF 812 and divisional policies for the conduct of clinical research
Management and supervision for all Research Incubator clinical research staff
Establish professional relationships with Contract Research Organizations, Pharmaceutical Sponsors, Funders and Grantors
Collaboration with departmental, Research Incubator, and divisional stakeholders for clinical research
Works with leadership, advisory compliance committee members and research unit leaders to establish a culture of research compliance
Advises the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners
Plans and manages the protocol review process for all clinical trials which includes the receipt and coordination of protocols for review, committee meetings, and clinical research conferences
Manages PI and other senior research faculty and personnel, participates as a skilled individual contributor and/or lead researcher as expert in specialized area. Ensures research projects progress according to plan by overseeing the coordination of the daily clinical trial activities
Performs other related work as needed
Qualification
Required
Minimum requirements include a college or university degree in related field
Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline
Oversee Departmental Clinical Research Portfolio across the lifecycle for each protocol from feasibility, startup, recruitment, day-to-day conduct, follow up through study close out
Coordinate departmental clinical research staff and faculty meetings
Oversee the conduct of clinical research, regulatory compliance, and IRB filings for all projects in the departmental portfolio
Establish documentation standards for departmental scientific review and feasibility for all proposed clinical research projects
Establish departmental standard work and standard operating procedures
Monthly Reports of site performance and percent effort reports
Training and onboarding of all research staff in GCP, 21 CFR 11, 21 CFR 312, 21 CF 812 and divisional policies for the conduct of clinical research
Management and supervision for all Research Incubator clinical research staff
Establish professional relationships with Contract Research Organizations, Pharmaceutical Sponsors, Funders and Grantors
Collaboration with departmental, Research Incubator, and divisional stakeholders for clinical research
Works with leadership, advisory compliance committee members and research unit leaders to establish a culture of research compliance
Advises the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners
Plans and manages the protocol review process for all clinical trials which includes the receipt and coordination of protocols for review, committee meetings, and clinical research conferences
Manages PI and other senior research faculty and personnel, participates as a skilled individual contributor and/or lead researcher as expert in specialized area
Ensures research projects progress according to plan by overseeing the coordination of the daily clinical trial activities
Performs other related work as needed
Preferred
Master's Degree strongly preferred
Experience with both industry sponsored FDA regulated clinical trial and investigator initiated clinical trial site management
Regulatory support for FDA and IRB filings
Protocol development support experience
ACRP / SOCRA research certification
Mentors or trains others to communicate effectively with CRO and/or sponsor, and in managing and conducting site visits
Creates and maintains departmental infrastructure for scientific review, feasibility assessment and projected effort/protocol
Determines and manages complex study and equipment resources for more than one study, and processes related to their management
Forecasts study needs, including staffing
Effectively solves complex problems related to managing resources
Ensure that multiple studies are conducted in compliance with institutional requirements and other policies
Mentor others in this area
Develops, follows, and implements detailed complex operational plans for research protocol(s)
Partnering with faculty set site performance metrics and targets: enrollment, retention, data quality, start-up timeline, Unanticipated Problem rate etc
Works with team to understand root cause of metric in non-conformance and take appropriate actions
Measures impact of preventive and corrective actions
For complicated scenarios, recognizes when all types of agreements (MTAs, CTAs, CDAs, DUAs, DTAs, etc.) are necessary and which procedures to follow
Prepares and maintains FDA regulatory submissions on more than one PI-initiated study overseen by the FDA
Handles complex situations and/or potential hold issues directly with the FDA, in collaboration with the PI
Demonstrates advanced application and knowledge of monitoring and audits
Trains or leads others in most tasks related to monitoring and audits
Sets meeting objectives, goals and detailed agendas for multidisciplinary meetings
Mentors or trains others in meeting preparation and follow up
Facilitates healthy communication during meetings
Conduct and document informed consent for multiple interventional and/or complex studies
Exhibit additional knowledge or skills in consent procedures
Advanced understanding of sponsor/regulatory reporting
Independently develops, or guides the development, of multiple complex data entry or collection protocols and tools
Systems are developed to ensure quality of data
Trains others in collecting and entering data
Benefits
Health, retirement, and paid time off
Company
University of Chicago
One of the world’s great intellectual destinations, the University of Chicago empowers scholars and students to ask tough questions, cross disciplinary boundaries, and challenge conventional thinking to enrich human life around the globe.
10001+ employees
H1B Sponsorship
University of Chicago has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (341)
2024 (318)
2023 (285)
2022 (233)
2021 (179)
2020 (172)
Funding
Current Stage
Late StageLeadership Team
Benedicte Nolens
Distinguished Executive in Residence
Recent News
2025-11-08
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2025-10-23
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