Clinical Research Manager, Research Incubation Unit

University of Chicago•Chicago, IL

4d•Onsite

About The Position

The Office of Clinical Research (OCR) is seeking a Clinical Research Manager for its Research Incubation Unit. This role manages a team of professional staff responsible for clinical research conduct, including data collection, documentation, analysis, and reporting. The manager will oversee strategic, administrative, operational, and financial decisions impacting clinical research across the University. The Research Incubation Unit aims to foster growth in clinical research portfolios and provide timely research staffing services. Key responsibilities include staff recruitment, onboarding, training, day-to-day management, supporting study milestones, tracking metrics, and communicating with various stakeholders. This position reports to the Director of Clinical Research Operations.

Requirements

College or university degree in a related field.
7+ years of work experience in a related job discipline.
Resume (required)

Nice To Haves

Master's Degree strongly preferred.
Experience with both industry sponsored FDA regulated clinical trial and investigator initiated clinical trial site management.
Regulatory support for FDA and IRB filings.
Protocol development support experience.
ACRP/SOCRA research certification.
Mentors or trains others to communicate effectively with CRO and/or sponsor, and in managing and conducting site visits.
Understands the relationship between sites, sponsors and CROs in order to solve problems.
Creates and maintains departmental infrastructure for scientific review, feasibility assessment and projected effort/protocol.
Determines and manages complex study and equipment resources for more than one study, and processes related to their management.
Forecasts study needs, including staffing.
Effectively solves complex problems related to managing resources.
Ensures that multiple studies are conducted in compliance with institutional requirements and other policies. Mentor others in this area.
Develops, follows, and implements detailed complex operational plans for research protocol(s) (those that require coordination of multiple units or services).
Partners with faculty to set site performance metrics and targets: enrollment, retention, data quality, start-up timeline, Unanticipated Problem rate etc. and works with team to understand root cause of metric in non-conformance and take appropriate actions.
Measures impact of preventive and corrective actions.
For complicated scenarios, recognizes when all types of agreements (MTAs, CTAs, CDAs, DUAs, DTAs, etc.) are necessary and which procedures to follow, including special terms that may need to be included.
Prepares and maintains FDA regulatory submissions on more than one PI-initiated study overseen by the FDA.
Handles complex situations and/or potential hold issues directly with the FDA, in collaboration with the PI.
Demonstrates advanced application and knowledge of monitoring and audits. Trains or leads others in most tasks related to monitoring and audits.
Sets meeting objectives, goals and detailed agendas for multidisciplinary meetings. Mentors or trains others in meeting preparation and follow up. Facilitate healthy communication during meetings.
Conduct and document informed consent for multiple interventional and/or complex studies. Exhibit additional knowledge or skills in consent procedures.
Advanced understanding of sponsor/regulatory reporting.
Independently develops, or guides the development, of multiple complex data entry or collection protocols and tools. Systems are developed to ensure quality of data. Trains others in collecting and entering data.
Cover Letter (preferred)

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.
Provide training and onboarding for all research staff in GCP, 21 CFR 11, 21 CFR 312, 21 CF 812 and divisional policies for the conduct of 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.
Manage PI and other senior research faculty and personnel, participate as a skilled individual contributor and/or lead researcher as expert in specialized area.
Ensure research projects progress according to plan by overseeing the coordination of the daily clinical trial activities.
Manage and direct the protocol review process for all clinical trials which includes the receipt and coordination of protocols for review, committee meetings, and clinical research conferences.
Plan and manage the protocol review process for all clinical trials which includes the receipt and coordination of protocols for review, committee meetings, and clinical research conferences.
Perform other related work as needed.