Qureos Mentor

The University of Chicago

<div>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 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 on behalf of our diverse community of patients and volunteers. Together, we elevate the human experience with knowledge and health care. 
Job Summary
The job 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. Manages the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University. 
 
The Clinical Research Manager is part of the Research Incubation Unit of the Office of Clinical Research. The Clinical Research Incubation Unit was established to enable growth of clinical research portfolios across the Biological Sciences Division as well as provide timely research staffing services to departments or units in need of short-term clinical research management services. The Clinical Research Manager manages a team of professional staff responsible for clinical research conduct , research participant management, data management, and regulatory. Key responsibilities of the Manager include recruiting, onboarding, and training of new clinical research staff; day-to-day management and supervision of clinical research staff; supporting study initiation and completion of key milestones throughout the life cycle of the trials; tracking and reporting on key metrics; communicating with investigators and department leaders; communicating with industry sponsors and internal stakeholders; and fulfilling service level agreement performance standards. This position will have primary accountability to the Director of Clinical Research Operations within the Office of Clinical Research.
Responsibilities<ul><li>
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.</li><li>
Coordinate departmental clinical research staff and faculty meetings.</li><li>
Oversee the conduct of clinical research, regulatory compliance, and IRB filings for all projects in the departmental portfolio.</li><li>
Establish documentation standards for departmental scientific review and feasibility for all proposed clinical research projects.</li><li>
Establish departmental standard work and standard operating procedures.</li><li>
Monthly Reports of site performance and percent effort reports.</li><li>
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.</li><li>
Management and supervision for all Research Incubator clinical research staff.</li><li>
Establish professional relationships with Contract Research Organizations, Pharmaceutical Sponsors, Funders and Grantors.</li><li>
Collaboration with departmental, Research Incubator, and divisional stakeholders for clinical research.</li><li>
Works with leadership, advisory compliance committee members and research unit leaders to establish a culture of research compliance.</li><li>
Advises the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners.</li><li>
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.</li><li>
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.</li><li>
Performs other related work as needed.</li></ul> 
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field. 
Work Experience:
Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline. 
Certifications:
-
Preferred Qualifications
Education:<ul><li>
Master's Degree strongly preferred.</li></ul>
Experience:<ul><li>
Experience with both industry sponsored FDA regulated clinical trial and investigator initiated clinical trial site management.</li><li>
Regulatory support for FDA and IRB filings.</li><li>
Protocol development support experience.</li></ul>
Licenses and Certifications:<ul><li>
ACRP / SOCRA research certification.</li></ul>
Preferred Competencies<ul><li>
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.</li><li>
Creates and maintains departmental infrastructure for scientific review, feasibility assessment and projected effort/protocol.</li><li>
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.</li><li>
Ensure that multiple studies are conducted in compliance with institutional requirements and other policies. Mentor others in this area.</li><li>
Develops, follows, and implements detailed complex operational plans for research protocol(s) (those that require coordination of multiple units or services).</li><li>
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.</li><li>
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.</li><li>
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.</li><li>
Demonstrates advanced application and knowledge of monitoring and audits. Trains or leads others in most tasks related to monitoring and audits.</li><li>
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.</li><li>
Conduct and document informed consent for multiple interventional and/or complex studies. Exhibit additional knowledge or skills in consent procedures.</li><li>
Advanced understanding of sponsor/regulatory reporting.</li><li>
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.</li></ul>
Working Conditions<ul><li>
Office Environment (ADA compliant).</li><li>
Clinical care units where research is conducted, and department lab space for specimen processing.</li></ul>
Application Documents<ul><li>
Resume (required)</li><li>
Cover Letter (preferred)</li></ul><div><div><div><div><div><div><div> 
When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.</div></div></div></div></div></div></div> 
Job Family
Research 
Role Impact
People Manager 
Scheduled Weekly Hours
40 
Drug Test Required
No 
Health Screen Required
No 
Motor Vehicle Record Inquiry Required
No 
Pay Rate Type
Salary 
 
FLSA Status
Exempt 
 
Pay Range
$90,000.00 - $130,000.00
The included pay rate or range represents the University&rsquo;s good faith estimate of the possible compensation offer for this role at the time of posting. 
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. 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, 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. 
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. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position. 
The University of Chicago's Annual Security &amp; Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: http://securityreport.uchicago.edu. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.</div>

Clinical Research Manager, Research Incubation Unit

<div>Serving pre-kindergarten through 5th grade, Donoghue is the second public elementary campus of the University of Chicago Charter School Corporation. Donoghue, which opened in 2005, is a college preparatory campus committed to professional development, inquiry, and high expectations for all staff and students. Donoghue serves as a catalyst for community building by offering programs for students and families beyond the school day. 
Position Summary: 
This position will support specialized instruction and case management for students with disabilities. This position supports special education teachers, general education teachers, and support staff in identifying, developing, and implementing curriculum, assessment, and instructional strategies designed to improve the learning of students with disabilities (diverse learners). This position requires a professional who works with a high level of independence and professional discretion under the general supervision of the Campus Director in partnership with the UCCS Network Director of Special Education. 
Duties and Responsibilities:
<ul><li>Create and distribute calendar of all annual reviews and evaluations to comply with IDEA timelines, and provide updates as needed.
</li><li>Chair and coordinate all IEPs and 504s.
</li><li>Ensure parents and students receive all meeting paperwork and understand the IEP and 504.
</li><li>Monitor and ensure implementation of all IEP services, accommodations and progress monitoring.
</li><li>Obtain IEPs and special education files for newly enrolled students and coordinate services for new students.
</li><li>Ensure all IEPs are relevant and compliant with Federal and State Law.
</li><li>Coach staff on how to interpret and write quality Individualized Education Plans (IEPS).
</li><li>Meet regularly with School Director the UCCS Network Director of Special Education to collaborate, communicate, and continuously improve the special education program.
</li><li>Meet regularly with special education teachers, monitor IEP work and provide feedback on IEPs.
</li><li>Develop and facilitate professional learning opportunities that promote achievement for diverse learners.
</li><li>Design professional development for administrators, teachers, and support staff in areas including curriculum, instruction, assessment, classroom management, and working with students with challenging behavior.
</li><li>Collaborate with both special education and general education teachers in planning for student learning outcomes based on assessed needs of individual students and the use of data and information to determine each student&rsquo;s current knowledge and skill level, support student learning goals, and assess student progress.
</li><li>Advise special education teachers on best practices in collaboration with general education teachers and co-teaching methods.
</li><li>Provides consultation to school staff working with diverse learners in the following areas: instruction, assessment, curriculum, communication, behavior, organization, use of visual systems, self-management, sensory needs, social skills and the design of the physical environment in the classroom and remote learning strategies.
</li><li>Actively participate as an advisor, resource specialist, and facilitator in faculty, grade level, department, and/or professional learning community meetings.
</li><li>Other responsibilities as needed.
</li></ul>Position Qualifications:
<ul><li>Commitment to the success and achievement of all students, and especially diverse learners.
</li><li>Valid Professional Educator License (PEL) with an LBS I endorsement required.
</li><li>Bachelor&rsquo;s or Master&rsquo;s degree in special education required.
</li><li>Minimum 5 years&rsquo; experience serving as a Case Manager required.
</li><li>Minimum 5 years&rsquo; experience serving as a Special Education Teacher required.
</li><li>Substantial experience serving in an urban teaching environment preferred.
</li><li>Substantial experience successfully coaching other teachers to improve instructional practice, either in general education or special education.
</li><li>Strong knowledge of federal and state laws and regulations regarding the delivery of special education and related services.
</li><li>Ability to establish and maintain effective working relationships with administrators, staff, students, parents, and community partners.
</li><li>Ability to communicate clearly with multiple stakeholders.
</li></ul>Salary Range 
$80,000 - $90,000 
The included pay rate or range represents the University of Chicago Charter School's good faith estimate of the possible compensation offer for this role at the time of posting. The salary will be commensurate of years of experience and education. 
Benefits 
UChicago Charter School offers a wide range of benefits programs for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits guide . 
UCCS recruits, hires, compensates, promotes and otherwise manages employees and prospective employees on the basis of individual merit without regard to race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, disability, genetic information, veteran status or any and all other factors protected by law. This policy includes UCCS&rsquo;s commitment to maintain a workplace free from sexual or other unlawful harassment or discrimination of any nature.</div>

Special Education Case Manager - 2026/2027 School Year (Donoghue Campus)

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Clinical Research Manager, Research Incubation Unit

Special Education Case Manager - 2026/2027 School Year (Donoghue Campus)