Clinical Research Manager, Research Incubation Unit

About the Department 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 the University of Chicago Medicine human subject research portfolio. The mission of OCR is to catalyze clinical research by offering expertise, resources, infrastructure, and systems that facilitate clinical research operations and enable collaboration across the enterprise while promoting compliance and human subject protection on behalf of our diverse community of patients and volunteers. Together, we elevate the human experience with knowledge and health care. Job Summary The Clinical Research Manager leads a team of professional staff responsible for clinical research conduct, participant management, data management, and regulatory support. The Manager oversees strategic, administrative, operational, and financial decisions impacting clinical research across the University and supports study initiation and completion across the trial lifecycle. The position reports to the Director of Clinical Research Operations within the Office of Clinical Research. Responsibilities Oversee the 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 clinical research conduct, regulatory compliance, and IRB filings for all projects in the portfolio. Establish documentation standards for scientific review and feasibility for all proposed clinical research projects. Develop department standard work and standard operating procedures. Generate monthly performance reports and percent effort reports. Train and onboard all research staff in GCP, 21 CFR 11, 21 CFR 312, 21 CFR 812 and divisional policies. Manage and supervise all Research Incubator clinical research staff. Build and maintain professional relationships with Contract Research Organizations, pharmaceutical sponsors, funders, and grantors. Collaborate with departmental, Research Incubator, and divisional stakeholders to advance clinical research. Work with leadership, advisory compliance committee members and research unit leaders to foster a culture of research compliance. Advisory on the development of a formalized training program for new and existing staff. Plan and manage protocol review processes, protocol receipt, committee meetings, and research conferences. Manage PI and senior research faculty, serving as an expert contributor when required to oversee daily trial activities. Perform other related work as needed. Education Minimum: college or university degree in a related field. Preferred: Master’s degree strongly preferred. Experience Minimum: 7+ years of work experience in a related discipline. Preferred: Experience with both industry‑sponsored FDA‑regulated clinical trials and investigator‑initiated clinical trials site management. Regulatory support for FDA and IRB filings. Protocol development support experience. Certifications Preferred: ACRP / SOCRA research certification. Competencies Mentors or trains others to effectively communicate with CROs and sponsors, 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 multiple studies, including related processes and forecasting needs. Ensures compliance with institutional requirements and mentors others in compliance. Develops, follows, and implements detailed complex operational plans for multidisciplinary research protocols. Partners with faculty to set site performance metrics and target goals, and works with team to resolve metric non‑conformance. Recognizes necessary agreements (MTAs, CTAs, CDAs, DUAs, DTAs, etc.) and follows appropriate procedures. Prepares and maintains FDA regulatory submissions for multiple PI‑initiated studies, handling complex issues directly with the FDA. Demonstrates advanced application and knowledge of monitoring and audits, training or leading others in related tasks. Sets meeting objectives, goals, and agendas for multidisciplinary meetings, and mentors others in preparation and follow‑up. Conducts and documents informed consent for multiple interventional or complex studies, exhibiting advanced knowledge of consent procedures. Advanced understanding of sponsor/regulatory reporting. Independently develops or guides the development of complex data entry or collection protocols and tools, ensuring data quality. Working Conditions Office Environment (ADA compliant). Clinical care units where research is conducted, and department lab space for specimen processing. Compensation Pay Range: $90,000.00 – $130,000.00 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. Equal Opportunity Employer The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University’s Notice of Nondiscrimination. #J-18808-Ljbffr University of Chicago