Clinical Research Manager, Research Incubation Unit

Clinical Research Manager, Research Incubation Unit

Join to apply for the Clinical Research Manager, Research Incubation Unit role at Biological Sciences Division at the University of Chicago

$90,000.00 per year – $ per year

BSD OCR – Clinical Research Operations

The Office of Clinical Research (OCR) is the nucleus of the clinical research enterprise, providing services, training, tools, and compliance oversight to support the conduct of clinical research across the entire Biological Sciences Division and University of Chicago Medicine human subject research portfolio. The mission of OCR is to catalyze clinical research by providing expertise, resources, infrastructure, and systems that facilitate clinical research operations and enable collaboration across the enterprise while promoting compliance and human subject protection for our diverse community of patients and volunteers.

The Clinical Research Manager is part of the Research Incubation Unit of OCR. The Manager oversees a team of professional staff responsible for clinical research conduct, participant management, data management, and regulatory compliance. Key responsibilities include recruiting, onboarding, and training staff; day‑to‑day management; supporting study initiation and milestone completion; tracking metrics; communicating with investigators, industry sponsors, and stakeholders; and meeting service level agreement performance standards.

The position reports to the Director of Clinical Research Operations.

• 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.
• Prepare monthly reports of site performance and percent effort reports.
• Train and onboard all research staff in GCP, 21 CFR 11, 21 CFR 312, 21 CFR 812 and divisional policies for clinical research.
• Manage and supervise all Research Incubator clinical research staff.
• Establish professional relationships with Contract Research Organizations, Pharmaceutical Sponsors, Funders and Grantors.
• Collaborate with departmental, Research Incubator, and divisional stakeholders for clinical research.
• Work 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.
• Plan and manage the protocol review process for all clinical trials, including receipt and coordination of protocols for review, committee meetings, and clinical research conferences.
• Manage PI and other senior research faculty and personnel, participate as a skilled individual contributor and/or lead researcher as an expert in a specialized area, ensuring research projects progress according to plan by overseeing coordination of daily clinical trial activities.
• Perform other related work as needed.

Minimum:
College or university degree in a related field.

Preferred:
Master’s Degree.

Minimum: 7+ years of experience in a related discipline.

Preferred:
Experience with FDA‑regulated clinical trials and investigator‑initiated site management; regulatory support for FDA and IRB filings; protocol development support.

• ACRP / SOCRA research certification.

• Mentor or train others to communicate effectively with CROs or sponsors and manage site visits; understands the relationship between sites, sponsors, and CROs to solve problems.
• Create and maintain departmental infrastructure for scientific review, feasibility assessment, and projected effort/protocol.
• Determine and manage complex study and…