Clinical Research Manager, Research Incubation Unit

About the Department BSD OCR - Clinical Research Operations 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 the Office of Clinical Research 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. Together, we elevate the human experience with knowledge and health care. Job Summary The Clinical Research Manager 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. The Manager oversees strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University. Key responsibilities include recruiting, onboarding, and training of staff; day‑to‑day management and supervision; supporting study initiation and completion of milestones; tracking and reporting key metrics; communicating with investigators, department leaders, industry sponsors, and internal stakeholders; and fulfilling service level agreement performance standards. Responsibilities Oversee departmental clinical research portfolio across the lifecycle for each protocol. Coordinate departmental research staff and faculty meetings. Oversee conduct of research, regulatory compliance, and IRB filings. Establish documentation standards for scientific review and feasibility. Establish standard operating procedures. Generate monthly reports of site performance and effort. Train and onboard staff in GCP, 21 CFR 11, 21 CFR 312, 21 CFR 812, and divisional policies. Manage and supervise all Incubator research staff. Build professional relationships with CROs, sponsors, funders, grantors. Collaborate with stakeholders to promote research compliance. Advise on formal training programs for new and existing staff. Plan and manage protocol review process, including receipt and coordination of protocols for review, committee meetings, and conferences. Manage PI and senior research faculty, ensuring projects progress according to plan. Perform other related work as needed. Minimum Qualifications College or university degree in a related field. At least 7 years of experience in a related discipline. Preferred Qualifications Master's Degree strongly preferred. Experience with both industry‑sponsored FDA‑regulated clinical trials and investigator‑initiated trials. Regulatory support for FDA and IRB filings. Protocol development support experience. ACRP / SOCRA research certification. Mentors or trains others to communicate effectively with CROs and sponsors, and to manage site visits. Creates and maintains infrastructure for scientific review, feasibility assessments, and effort/protocol projections. Determines and manages complex study and equipment resources for multiple studies and related processes. Ensures compliance with institutional requirements and mentors others in that area. Develops and implements detailed operational plans for complex protocols involving multiple units. Partners with faculty to set site performance metrics and targets, and works with team to address metric deviations. Recognizes necessary agreements (MTAs, CTAs, CDAs, DUAs, DTAs) and follows appropriate procedures. Prepares and maintains FDA regulatory submissions for multiple PI‑initiated studies, handling complex issues directly with FDA. Trains or leads others in monitoring and audit tasks. Sets meeting objectives, goals, and detailed agendas for multidisciplinary meetings; mentors others in meeting preparation and follow‑up. Conducts and documents informed consent for interventional and complex studies. Has advanced understanding of sponsor and regulatory reporting. Develops complex data entry or collection protocols and tools, and trains others. Working Conditions Office environment (ADA compliant). Clinical care units where research is conducted, and department lab space for specimen processing. Pay Range $90,000.00 – $130,000.00 Benefits Eligible Yes. The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Posting Statement The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, 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 Biological Sciences Division at the University of Chicago