The IRB Manager is responsible for regulatory and accreditation compliance of the IRB review and oversight process as it relates to human research at Northwestern University. This role manages workflow and processes for assigned IRB office and IRB Panel review. Oversees all routine and non-routine IRB administrative functions, including the supervising and training of IRB Analysts and other assigned staff. Manages issue and complaint resolution related to IRB submission and review processes. Work closely with research community on matters related to the determinations and decisions of the IRB. This position is a member of IRB Office leadership team, with shared responsibility for success of the office in accomplishing strategic goals.
Manages staff workload and assignments.
Oversees workflow and processes of the IRB Panels in order to ensure processes are in compliance with federal and state regulations for human subject research.
Prepares technical institutional and federal documents that may be auditable for IRB panels.
Oversees the review of research protocols to identify potential problems.
Serves as subject matter expert in State and Federal laws and regulations as they apply to human subjects.
Leads collaborative efforts regarding IRB processes within the research community to facilitate improved communication and foster research growth while assuring a quality human research protection program.
Facilitate collaborative conflict resolution and problem solving for complex regulatory and ethical issues related to human research.
Oversees process for tracking turnaround times and backlogs for audit purposes.
Serve as a primary resource to the NU research community as well as to the Panel Chairs, the Chair for Administrative Review and IRB members regarding pertinent regulatory requirements.
Identify areas of risk and potential non-compliance and collaborate with IRB leadership, IRB staff, IRB chairs and IRB Compliance Program to develop and implement corrective and preventative action plans.
Coordinates resolution of compliance problems, issues and decisions with IRB leadership and IRB staff, as well as other departments within the Office of Research, e.g. Office of Research Integrity (ORI), Office of Sponsored Research (OSR).
Oversees staff as they assist IRB chairs, members, and researchers on the regulations and ethical principles essential to the review process.
Serves as a Designated Reviewer making regulatory determinations.
Oversees the development and implementation process of the eIRB system.
Provide training for IRB staff as required.Facilitate professional development of direct and indirect reports.
Develop and presents training materials on the ethical conduct of research involving human subjects.
Provides training as necessary to faculty and staff on the regulations and on preparation of applications and consent forms.
Participates in specials projects for the office.
Provides backup to the IRB staff with regard to IRB process.
Performs other duties as assigned.
Master’s degree in a scientific, healthcare or related field with 7 or more years of work experience in progressively more responsible positions and CIP certification or the equivalent combination of education and experience where similar knowledge, skills and abilities were acquired.5 years experience in regulatory affairs or IRB management role.
Minimum Competencies: (Skills, knowledge, and abilities.)
Demonstrated knowledge of federal, state and local regulation governing the participation of human subjects in research.
Demonstrated competencies:computer proficiency, report writing, and research regulations.
Demonstrated written and oral communication skills.
Ability to work independently and as part of a team in a fast paced and highly stressed environment.
Possess interpersonal and time management skills.
Preferred Qualifications: (Education and experience)
Certification as an IRB professional or manger.
Active participation in the community of IRB professionals.
Program management experience.
Ability to communicate clearly in writing, in person and by telephone.
Preferred Competencies: (Skills, knowledge, and abilities)
Knowledgeable of federal, state and local regulations in order to be in position to explain the reasons for the requirements of the IRB.
Ability to assert her or himself appropriately in IRB meetings and in other contexts in order to represent the ORPS, the policies and procedures of the Office for Research, and the federal, state and local regulations and guidance pertaining to human subject protections.
Ability to assess risk.
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: 36205
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.