Clinical Research Manager, Research Incubation Unit

About the role

The job manages a team of professional staff responsible for performing clinical research including the collection, documentation, analysis of clinical trial data, and reporting of clinical research data. Manages the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University.

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.
• Cookplicate 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 CFR 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.
• Advise 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.

Qualifications

• 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.

Preferred Qualifications

• A Master's Degree is strongly preferred.

Benefits

The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.