Department: MED-NU-CATS Institute Salary/Grade: EXS/7
The NUCATS Institute’s Quality Assurance and Quality Control Specialist (QA/QC) is responsible for managing, in collaboration with the NUCATS leadership team, activities across four domain areas in support of Institute initiatives and the Feinberg School of Medicine’s research ecosystem, including: direct oversight of NUCATS’ submissions to the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health; direct consultations for non-CTSA submissions to NCATS and other NIH institutes and centers; education and training; and metrics & continuous improvement initiatives. The Northwestern University Clinical and Translational Sciences Institute serves as an integrated hub to advance Clinical and Translational Science at three distinct scales: locally, at Northwestern University and our 3 nationally-renowned clinical partners; regionally, across Chicago and in collaboration with the other two Chicago CTSA hubs and our many community stakeholder partners; and, nationally, through our active participation in the CTSA Consortium.
**PLEASE NOTE: Position is 100% NIH grant funded through June 30, 2024. Extension is contingent upon grant renewal.
Direct Oversight of NUCATS’ Submissions to NCATS:
Collaborate with the NUCATS Institute’s Administrative Director, Research Administrator, and our Authorized Organizational Representative (AOR) to pre-review all submissions to our funding agency (including: all prior approval requests related to key personnel transitions, KL2 and pilot award research projects involving human subjects or vertebrate animals, diversity supplement scholars, CD2H initiatives, as well as competitive and administrative supplements); Develop, pilot, and implement rigorous Standard Operating Procedures (SOPs), comprehensive checklists, and standardized review workflows to ensure completeness and accuracy of all submissions to our funding agency.
Direct Consultations for non-CTSA Submissions to NCATS and other NIH Institutes and Centers
Provide extensive consultation services to all Trial Innovation Network-supported projects funded by the National Institutes of Health and originating from Northwestern University as well as trials/studies for which Northwestern University (or a clinical affiliate) is engaged as a participating site throughout the grant lifecycle.
Provide direct consultation support to all largescale ‘P’ and ‘U’ applications and funded projects linked to the National Institutes of Health and originating from Northwestern University throughout the grant lifecycle. These services are intended for proposals that will use NUCATS and other institutional infrastructure resources and services.
May provide consultation services to other NIH funding mechanisms with approval from CTSA PI and CTSA Administrative Director.
Collaborate with the Galter Health Sciences Library and Learning Center (organized as an associated center within our CTSA hub, and including the library’s Metrics & Impact Core) and NUCATS’ Evaluation and Continuous Improvement Program on compliance-related matters such as PubMed Central and open access policy compliance through collaborative development of training opportunities and best practice materials. This role will also collaborate with Galter Library colleagues to promote Galter’s best practices around enhancing NIH biosketches with advanced bibliometrics and Altmetrics.
Education & Training Nexus:
Collaborate with NUCATS colleagues as well as Northwestern’s Office of Sponsored Research, Institutional Review Board, IACUC, Institutional Biosafety Committee, Office for Research Safety, etc. to develop, test, evaluate, and disseminate in-person and on-line training workshops and modules as well as resource guides and infographics to educate the clinical and translational research community on complying with NIH prior approval, submission, and annual reporting (RPPR) requirements. Topics may include: how to navigate the eRA Human Subjects System; understanding the prior approval process and timeline; ensuring compliance with NIH key personnel transition requirements, etc.
Building upon our highly successful NUCATS grants repository, this role will create a companion repository of templated materials for NIH-targeted grants (e.g., human subjects Forms-F (and successor Forms packets), resources and environment, inclusion of women, underrepresented minorities, and children, etc.), templated language for project-specific customization around rigor & reproducibility of research, and best practice & resource guides. Primary target audience includes NUCATS administrative core and component leads, KL2 scholars, TL1 trainees (via research mentors), pilot awardees, diversity supplement scholars, and NCATS supplements attached to the NUCATS parent grant.
As part of NCATS’ and NUCATS’ shared mission of accelerating clinical and translational research to improve human health, this role will also support education and training efforts for researchers and clinical research staff across Northwestern University and our clinical affiliates engaged in human subjects research (including Northwestern Memorial HealthCare Corporation, Lurie Children’s Hospital of Chicago, and Shirley Ryan Ability Lab
Furthermore, these education and training materials will be posted on the NUCATS website and made available to the CTSA consortium in an editable format (whenever possible), thereby allowing other CTSA hubs to edit materials to reflect local policies and workflows and to update branding.
Once program is established, this role will design, test, and disseminate a “train-the-trainer” curriculum to be offered to researchers and research staff at: Northwestern University, our three clinical affiliate systems, Chicago Department of Public Health, and community partner organizations.
Metrics & Continuous Improvement Initiatives:
In close collaboration with NUCATS’ Evaluation and Continuous Improvement Program, this role will help design and use NUCATS dashboards to track and report out on utilization, process, and output metrics such as: number and type of direct consultation requests; number and type of education and training presentations and interventions;turnaround times from: (a) request received to initial feedback provided; (b) initial feedback provided to request submitted to funding agency; (c) submission to funding agency to determination provided; number and type of edits and feedback provided; rate of submissions returned with: (a) approval – no edits; (b) approval – minor edits; (c) approval – major/substantive edits; (d) denied (and this outcome rate will be monitored over time) user satisfaction with services provided; reviewer satisfaction (e.g., Program Officer and Grants Management Specialist) with quality of submissions; and evaluations of satisfaction with and impact of education and training materials.
May provide consultation and assist local reporting and tracking for CTSA Common Metrics Initiatives and Insights to Inspire initiative related to Quality Assurance and Quality Control (QA/QC) in partnership with the Administrative Director and NUCATS Evaluation and Continuous Improvement Program, as appropriate.
Liaison with Feinberg School of Medicine Dean’s Office of Regulatory Affairs on clinical trial quality assurance.
As needed and assigned, this role may participate in training offered by NCATS or designee; attend regularly scheduled QA/QC webinars and participate in discussion forums; propose improvements and innovations to funding agency, and more.
Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a health-related field.
3-5 years of experience in clinical research, healthcare, and/or community partnerships (including experience as a Registered Nurse and/or mid-level provider), or other related experience.
Must complete Northwestern University’s IRB CITI training and Good Clinical Practices training, and other relevant regulatory certifications as needed, with successful recertification in a timely manner as needed.
Minimum Competencies: (Skills, knowledge, and abilities.)
Familiarity with Quality Assurance and Quality Control (QA/QC) and Project Management concepts; Human Subjects Research Regulations; and Institutional Processes.
Ability to operate independently and with initiative, with guidance provided by NUCATS’ senior leadership.
Ability to build and maintain strong, trusting relationships with supervisors, colleagues, and constituents is critical. The successful candidate will have experience presenting to investigative teams, end users (faculty and staff), and subject matter experts and must possess excellent facilitation, consensus-building, project management, and diplomacy skills and exhibit a strong
Excellent written and oral communications skills, including strong interpersonal communication skills to effectively and diplomatically engage with clinical research community members and provide constructive feedback.
Strong organizational, project management, and interpersonal skills.
Working knowledge of Word, Excel, and PowerPoint required.
Demonstrated organizational skills to prioritize and manage multiple projects, committees, teams, and deliverables.
Master’s or other graduate level degree (such as a Master’s in Public Health or completion of NUCATS’ Master of Science in Regulatory Compliance degree); OR the equivalent combination of education, training and experience from which comparable skills can be acquired.
Prior knowledge of, or participation in, CTSA-related activities.
Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes, including veterans and individuals with disabilities. Women, racial and ethnic minorities, individuals with disabilities, and veterans are encouraged to apply. Hiring is contingent upon eligibility to work in the United States.
Internal Number: 39046
About Northwestern University
Northwestern University is a major private research university with 12 academic divisions located on three campuses in Evanston, Chicago, and Education City in Doha, Qatar. We have approximately 2,500 full-time faculty members, 17,000 graduate and undergraduate students, and over 5,700 full and part-time staff. Northwestern University combines innovative teaching and pioneering research in a highly collaborative environment. It provides students and faculty exceptional opportunities for intellectual, personal and professional growth.