Participating in the review of initial project briefs and identifying potential quality and feasibility issues.
Meeting with all invited applicants at the start of the application development process to discuss the proposed project and identify potential quality and feasibility challenges.
Suggesting ITM consultations and services that the applicant can take advantage of as they prepare their application and handing the applicant off to those programs.
Meeting 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.
Reviewing final applications for completeness, internal consistency, and quality of regulatory (human subjects and vertebrate animals) paperwork.
Reviewing the human subjects research protocols in all final applications for feasibility and providing separate feasibility scores and review comments to the selection committee.
Performing quality reviews of all ITM pilot project submissions to NCATS including submissions to the eRA Human Subjects System.
Meeting 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, fostering accountability to pilot project timelines through regular check-in meetings with awardees and the maintenance of project management/progress documents.Â Aiding pilot awardees with identifying emerging problems/obstacles and implementing responsive solutions.
Â Participating in the ITMâ™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 studentsâ™ 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 projectâ™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.
Â Lecturing on protocol development and feasibility as part of the ITMâ™s Essentials of Patient Oriented Research curriculum.
Leading courses and workshops on protocol development for research staff.
Obtaining training from NCATS and other CTSA Consortium members through the national QA/QC group and incorporating this new knowledge into existing ITM workforce development activities.
Â Reviewing and improving 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.
Responding 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 questionerâ™s home institution.
Connecting the ITM to a national quality assurance/quality control community by participating in the CTSA Consortiumâ™s QA/QC group, attending quarterly virtual meetings; and participating in a virtual QA/QC Discussion Forum.
Manages 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.
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.
Performs other related work as needed.
Advanced degree in a health-related field
Certified clinical research professional, either through ACRP or SOCR
Clinician (nurse, physician) or have extensive clinical operations experience
Work independently to provide high-level assistance, counsel, and problem-solving to faculty and staff who seek the support or resources of the institute.Â
Use a broad base of knowledge to respond to questions or requests for help and then provide expert advice and/or directing inquirers to services or programs that can provide additional help and support, either within the ITM or at the questionerâ™s home institution.
Have the ability to evaluate the quality and feasibility of research projects that seek ITM support.Â To do so they must be able to read, understand, and critique scientific research protocols and anticipate and identify potential problems in research study execution and suggest practical, tractable solutions.Â
Possess real-world experience with all types of translational research, from investigator-initiated pathological, phenotypical or longitudinal research; to community-based, participatory research; to highly complex, industry-initiated clinical trials.Â They should also have significant experience in the many steps of the protocol lifecycle, from study design to regulatory oversight, consenting, study execution, clinical and nursing operations, data collection and management, reporting, and more.
Provide oversight and management services for the limited number of projects that receive direct support from the ITM.Â They will ensure the quality and accuracy of all regulatory submissions, the execution of highest-quality research, and the adherence to the project timeline.Â
Foster an atmosphere of accountability with the investigator and study team; works with the team to identify potential barriers and emerging problems that will slow the project; and then ensures that nimble, tractable solutions are implemented.
Possess outstanding communication skills to positively interact with a broad range of inquirers and collaborators, communicating with tact and precision.Â They are able to advocate for high-quality, ethical, safe, and feasible research projects, and to foster an atmosphere of accountability, all while maintaining the amicable, energetic engagement of the entire research team.
Cover Letter (required)
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Internal Number: JR09155
About University of Chicago (UC)
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