ITM Principal Navigator

Department
 

BSD ITM - Administration

About the Department
 

The University of Chicago (UC) Institute for Translational Medicine (ITM) was created in 2007 to assemble, integrate, and create the intellectual, administrative, and physical resources required to catalyze research and research training in Clinical and Translational Science. Its ultimate goals are to train scientists and health care providers at UC and in our community to determine the molecular, genetic, pathophysiologic, and social determinants of disease and disease predisposition in individuals; to test interventions directed toward those mechanisms; and to achieve these goals in a way that is rigorous, efficient, ethical, respectful of, and responsive to our community’s needs and values. Over its nine years, the ITM has capitalized on the outstanding intellectual and physical resources throughout the University and at ITM affiliate Institutions, Argonne National Laboratory, NorthShore University HealthSystem, Illinois Institute of Technology, and Access Community Health Network, and on substantial institutional and CTSA financial investments, to build the infrastructure for a transformative, energized, and self-improving home for clinical and translational research, ensuring the continued progress of clinical and translational science at the University of Chicago, its affiliates, on the South Side of Chicago, and beyond. This at-will position is wholly or partially funded by contractual grant funding which is renewed under provisions set by the grantor of the contract. Employment will be contingent upon the continued receipt of these grant funds and satisfactory job performance.

Job Summary
 

The job leads and provides expertise to the development of programs for the collection, documentation, analysis of clinical trial data, and reporting of clinical research data. Provides input into the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University.

Responsibilities

Within the National CTSA Consortium’s QA/QC Taskforce

The Principal Navigator as a member of the CTSA Program’s QA/QC Taskforce will:

• Provide strategic advice and direction to NIH/NCATS in the implementation of regulatory processes that govern the national CTSA program through regular meetings and participation in online discussion forums.

Within the ITM’s Pilot Project Development Program

The Principal Navigator will provide strategic direction in the ITM’s Pilot Project Development Program by directing the work of the Local Navigators and overseeing their work as they:

• Review initial project briefs and identify potential quality and feasibility issues.

• Meet with all invited applicants at the start of the application development process to discuss the proposed project and identify potential quality and feasibility challenges.

• Suggest ITM consultations and services that the applicant can take advantage of as they prepare their application and handing applicant off to those programs.

• Meet with invited applicants during the application development and review process to ensure that all regulatory requirements (i.e., IRB, IACUC) are met by the time of the award.

• Review final applications for completeness, internal consistency, and quality of regulatory (human subjects and vertebrate animals) paperwork.

• Review the human subjects research protocols in all final applications for feasibility and provide separate feasibility scores and review comments to the selection committee.

• Perform quality reviews of all ITM pilot project submissions to NCATS including submissions to the eRA Human Subjects System.

• Meet with pilot awardees at the start of the award period to finalize the project timeline and establish a schedule of regular progress check-in meetings.

• During the pilot award period, foster accountability to pilot project timelines through regular check-in meetings with awardees and the maintenance of project management/progress documents. 

• Aid pilot awardees with identifying emerging problems/obstacles and implementing responsive solutions.

Within the ITM’s Career Development (KL2) Program

The Principal Navigator will play a similar role within the KL2 program, directing and overseeing the work of the Local Navigators as they promote a focus on quality, feasibility, and accountability in the scholars’ development by:

• Participating in the ITM’s K Writing Workshop, presenting on quality, feasibility, and protocol development as one of the workshop faculty, and providing critiques of project feasibility during the students’ development of their K applications.

• Reviewing the human subjects research protocols in all KL2 applications for quality and feasibility and providing separate feasibility scores and review comments to the selection committee.

• Meeting with new KL2 scholars at the start of their appointment to finalize their project timeline and establish a schedule of regular progress check-in meetings.

• Ensuring that the KL2 scholars meet their project’s regulatory requirements (i.e., IRB, IACUC) at the appropriate time and in accordance with their timeline.

• Performing quality reviews of all ITM KL2 project submissions to NCATS including submissions to the eRA Human Subjects System.

• Fostering accountability amongst the KL2 scholars through the leading of project check-in seminars where all the scholars present to each other on their project progress, identify emerging problems/obstacles, and brainstorm together on responsive solutions.

Within the ITM’s Workforce Development Program

The Principal Navigator will enhance the development of a highly-competent, advanced research workforce at ITM institutions by:

• Lecturing on protocol development and feasibility as part of the ITM’s Essentials of Patient-Oriented Research curriculum.

• Leading courses and workshops on protocol development for research staff.

• Serving as a conduit of information about regulatory processes from the national QA/QC group and incorporating this new knowledge into existing ITM workforce development activities.

More broadly, within the ITM’s operations

The Principal Navigator will enhance the daily operations of the Institute by:

• Overseeing the work of the Local Navigators as they prepare all UL1- and KL2-related administrative interactions with NCATS, e.g., Prior Approval requests, eRA Human Subjects System submissions, and submissions of other documents to NCATS.

• Overseeing the NCATS submission processes for the ITM and proposing innovations/ improvements.

• Directing the work of the Local Navigators as they respond to incoming general requests for research help from faculty and staff at ITM institutions, providing high-level assistance, counsel, and problem-solving; and directing questioners to services or programs that can provide additional help and support, either within the ITM or at the questioner’s home institution.

• Solves the daily administrative and technical activities in a single highly complex, large clinical trial or multiple moderately complex, concurrent clinical trials. Designs and guides internal and external audits and manages external surveys.

• Leads and implements Good Clinical Practices (GCP) and all relevant current local, state, and federal laws, regulations, policies and procedures. Develops and implements consistent standards and protocols.

• Solves complex problems relating to data management and the analysis of large administrative datasets. Works independently to develop, manage, and report on key data and ensures timeliness of data and reporting submissions from multiple investigators.

• Provides expertise on the basics of clinical research and related aspects of clinical study for colleagues with less experience. Prepares and evaluates writing protocols, IRB submissions, grant applications, manuscripts, reports, and dissemination tools.

• Performs other related work as needed.

Minimum Qualifications
 

Education:

Minimum requirements include a college or university degree in related field.

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Work Experience:

Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications

Experience:

• 7+ years of work experience as a research manager or director of a research program strongly preferred.

​Preferred Competencies

• Have extensive experience directing the work of others.

• Be able to demonstrate knowledge of the regulatory requirements for translational research.

• Possess outstanding project management skills.

• Be able to demonstrate knowledge of quality assurance/quality control processes through certification/experience.

• Demonstrate outstanding communication skills and a high attention to detail.

Working Conditions

• The Principal Navigator works in an office environment but must also thrive working within an operational clinical research environment (e.g., a Clinical Research Center).

Application Documents

• Resume (required)

• Cover Letter (required)

When applying, the document(s) MUST  be uploaded via the My Experience page, in the section titled Application Documents of the application.

Job Family
 

Research

Role Impact
 

Individual Contributor

FLSA Status
 

Exempt

Pay Frequency
 

Monthly

Scheduled Weekly Hours
 

40

Benefits Eligible
 

Yes

Drug Test Required
 

Yes

Health Screen Required
 

Yes

Motor Vehicle Record Inquiry Required
 

No

Posting Statement
 

Employees must comply with the University’s COVID-19 vaccination requirements. More information about the requirements can be found on the University of Chicago Vaccination GoForward .
The University of Chicago is an Affirmative Action/ Equal Opportunity/Disabled/Veterans Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, status as an individual with a disability, protected veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.

 

Staff 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.

 

We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange.

 

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.

 

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