Biological Sciences Division at the University of Chicago ยท 2 months ago
Clinical Research Manager, Research Incubation Unit
Chicago, IL
Full-time
Onsite
Mid, Senior Level
$90K/yr - $130K/yr
7+ years expThe University of Chicago's Biological Sciences Division is seeking a Clinical Research Manager to join their Research Incubation Unit. This role involves managing a team responsible for clinical research operations, overseeing compliance, and facilitating collaboration across departments to support clinical trials.
Higher Education
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
Monthly Reports of site performance and percent effort reports
Training and onboarding of all research staff in GCP, 21 CFR 11, 21 CFR 312, 21 CF 812 and divisional policies for the conduct of clinical research
Management and supervision for all Research Incubator clinical research staff
Establish professional relationships with Contract Research Organizations, Pharmaceutical Sponsors, Funders and Grantors
Collaboration with departmental, Research Incubator, and divisional stakeholders for clinical research
Works with leadership, advisory compliance committee members and research unit leaders to establish a culture of research compliance
Advises the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners
Plans and manages the protocol review process for all clinical trials which includes the receipt and coordination of protocols for review, committee meetings, and clinical research conferences
Manages PI and other senior research faculty and personnel, participates as a skilled individual contributor and/or lead researcher as expert in specialized area. Ensures research projects progress according to plan by overseeing the coordination of the daily clinical trial activities
Performs other related work as needed
Qualification
Required
Minimum requirements include a college or university degree in related field
Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline
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
Monthly Reports of site performance and percent effort reports
Training and onboarding of all research staff in GCP, 21 CFR 11, 21 CFR 312, 21 CF 812 and divisional policies for the conduct of clinical research
Management and supervision for all Research Incubator clinical research staff
Establish professional relationships with Contract Research Organizations, Pharmaceutical Sponsors, Funders and Grantors
Collaboration with departmental, Research Incubator, and divisional stakeholders for clinical research
Works with leadership, advisory compliance committee members and research unit leaders to establish a culture of research compliance
Advises the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners
Plans and manages the protocol review process for all clinical trials which includes the receipt and coordination of protocols for review, committee meetings, and clinical research conferences
Manages PI and other senior research faculty and personnel, participates as a skilled individual contributor and/or lead researcher as expert in specialized area. Ensures research projects progress according to plan by overseeing the coordination of the daily clinical trial activities
Performs other related work as needed
Preferred
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
Ensure 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)
Partnering with faculty 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
Benefits
The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off.
Company
Biological Sciences Division at the University of Chicago
As part of the University of Chicago, the Biological Sciences Division (BSD) pursues globally impactful solutions to seemingly unsolvable challenges.
1001-5000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase