Biological Sciences Division at the University of Chicago
Clinical Research Manager, Research Incubation Unit
Biological Sciences Division at the University of Chicago, Chicago, Illinois, United States, 60290
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
Pay Range $90,000.00 per year – $130,000.00 per year
Department BSD OCR – Clinical Research Operations
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 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.
Job Summary 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.
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.
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.
Education Minimum: College or university degree in a related field.
Preferred: Master’s Degree.
Work Experience 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.
Licenses and Certifications
ACRP / SOCRA research certification.
Preferred Competencies
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 equipment resources for multiple studies, forecasting study needs, including staffing; solve complex resource management problems.
Ensure compliance with institutional requirements and mentor others.
Develop, follow, and implement detailed complex operational plans for multi‑unit or multi‑service protocols.
Partner with faculty to set site performance metrics and targets (enrollment, retention, data quality, start‑up timeline, unanticipated problem rate) and lead root‑cause analysis and corrective actions.
Handle complex agreements (MTAs, CTAs, CDAs, DUAs, DTAs) and procedures, including special terms.
Prepare and maintain FDA regulatory submissions for multiple PI‑initiated studies; manage hold issues directly with FDA.
Demonstrate advanced application and knowledge of monitoring and audits; train or lead others in audit tasks.
Set meeting objectives, agendas, and facilitate communication in multidisciplinary meetings.
Conduct and document informed consent for multiple interventional or complex studies; exhibit additional knowledge of consent procedures.
Possess advanced understanding of sponsor and regulatory reporting.
Independently develop or guide the development of complex data entry or collection protocols and tools; train others to ensure data quality.
Working Conditions
Office environment (ADA compliant).
Clinical care units where research is conducted, and department lab space for specimen processing.
Application Documents
Resume (required).
Cover Letter (preferred).
Benefits Eligible Yes.
The University of Chicago offers a wide range of benefits programs and resources, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.
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, gender identity, 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. Job seekers in need of a reasonable accommodation to complete the application process should call 773‑702‑5800 or submit a request via Applicant Inquiry Form. All offers of employment are contingent upon a background check that includes a review of conviction history.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Functions Research, Analyst, and Information Technology
Industries Higher Education
#J-18808-Ljbffr
Clinical Research Manager, Research Incubation Unit
role at
Biological Sciences Division at the University of Chicago
Pay Range $90,000.00 per year – $130,000.00 per year
Department BSD OCR – Clinical Research Operations
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 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.
Job Summary 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.
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.
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.
Education Minimum: College or university degree in a related field.
Preferred: Master’s Degree.
Work Experience 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.
Licenses and Certifications
ACRP / SOCRA research certification.
Preferred Competencies
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 equipment resources for multiple studies, forecasting study needs, including staffing; solve complex resource management problems.
Ensure compliance with institutional requirements and mentor others.
Develop, follow, and implement detailed complex operational plans for multi‑unit or multi‑service protocols.
Partner with faculty to set site performance metrics and targets (enrollment, retention, data quality, start‑up timeline, unanticipated problem rate) and lead root‑cause analysis and corrective actions.
Handle complex agreements (MTAs, CTAs, CDAs, DUAs, DTAs) and procedures, including special terms.
Prepare and maintain FDA regulatory submissions for multiple PI‑initiated studies; manage hold issues directly with FDA.
Demonstrate advanced application and knowledge of monitoring and audits; train or lead others in audit tasks.
Set meeting objectives, agendas, and facilitate communication in multidisciplinary meetings.
Conduct and document informed consent for multiple interventional or complex studies; exhibit additional knowledge of consent procedures.
Possess advanced understanding of sponsor and regulatory reporting.
Independently develop or guide the development of complex data entry or collection protocols and tools; train others to ensure data quality.
Working Conditions
Office environment (ADA compliant).
Clinical care units where research is conducted, and department lab space for specimen processing.
Application Documents
Resume (required).
Cover Letter (preferred).
Benefits Eligible Yes.
The University of Chicago offers a wide range of benefits programs and resources, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.
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, gender identity, 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. Job seekers in need of a reasonable accommodation to complete the application process should call 773‑702‑5800 or submit a request via Applicant Inquiry Form. All offers of employment are contingent upon a background check that includes a review of conviction history.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Functions Research, Analyst, and Information Technology
Industries Higher Education
#J-18808-Ljbffr