Northwestern University's IRB Office is rapidly expanding and is bolstering its infrastructure with additional staff positions to increase headcount.
The Senior IRB Compliance Analyst is primarily responsible for ensuring that the various research compliance activities and programs within Northwestern University (NU) adhere to Federal, State and local regulations as well as institutional policy. The Compliance analyst supports the IRB through post approval and for-cause auditing; organizes and manages the confidential review and monitoring process of complex research activities involving human subjects to; plans, organizes, and implements the IRB post approval monitoring program for researchers; initiates and applies new procedures as necessary to ensure that IRB panels and the NU Research Community operate at optimum effectiveness and efficiency; and promotes the high ethical standards NU demands in all research protocol and data collection in order to protect the safety, rights, and welfare of human research subjects.
The goal of the following activities is to ensure that all operational priorities are aligned with the mission and direction of IRB.
Ensures that IRB operations meet legal and regulatory requirements and are in compliance with ever more complex federal, state, and local regulations regarding the activities of IRB.
Assists the Manager for Compliance in the development and maintenance of compliance programs, including, but not limited to educational materials, associated forms and policies and internal procedures.
Monitors changes in laws, regulations, and technology and advises management how that may affect operations.
Conducts and reports the regulatory review of initial and continuing research protocol submissions to ensure federal regulatory compliance.
Substantively interprets federal and state regulations when conducting an analysis of the research project. Including determining regulatory risks whether, internal or external to the Institution and/or IRB office.
Participates in compliance audits. Communicates with investigators, compliance committees and appropriate parties, in written reports and correspondence the specific issues regarding non-compliance.
Schedule, conduct and provide timely reports of: Noncompliance investigations of Principal Investigators, audits and assessments of internal systems/process audits to assure compliance with SOPs and applicable regulations and guidelines. Routine and IRB panel directed site visits of domestic clinical investigators approved by the NU IRB, as directed.
Provides regulatory, ethical, and method advice to individual faculty and staff for research proposals involving human subjects and consent documents.
Recommends improvements for enhancing communication between the IRB, researchers and staff based upon compliance audits and feedback..
Serves as subject matter expert in state, local, and federal laws and regulations as they apply to human subjects.
Prepares auditable institutional and federal technical documents needed for IRB panels’ review and recommends contingencies for approval of research activities involving human subjects.
Contributes to the development of quality assurance initiatives, as well as other special projects as needed.
Assists in the development and revision of Standard Operating Procedures for the compliance component of the IRB office.
Assists IRB Managers in ensuring the university’s performance excellence program is administered responsibly and uniformly throughout the IRB Office.
Analysis and Training
The goal of the following activities is to ensure high quality services for Northwestern University’s researchers and staff involved with human research subjects administrative process.
Instructs IRB chairs, members, and researchers on the regulations and ethical principles essential to the ethical conduct of research.
Writes standard operation procedures to ensure consistency within the IRB office.
Develops and presents training materials on the ethical conduct of research involving human subjects.
Provides training and advice to faculty and staff on the regulations.
Conducts quality and assurance reports for management.
Oversees the analysis and creation of reports that tracks compliance issues related to federal requirements.
Provides guidance and support for the Department Assistant in the compliance division. •
Serves as backup to the IRB Compliance Manager, as needed.
Supervises and coordinates specials projects for the IRB Manager.
Represents IRB in committees when issues and concerns regarding regulatory compliance in human subject research are involved.
Performs other duties and responsibilities as assigned.
Work-Life and Wellness: Northwestern offers comprehensive programs and services to help you and your family navigate life’s challenges and opportunities, and adopt and maintain healthy lifestyles. We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at https://www.northwestern.edu/hr/benefits/work-life/index.html to learn more.
Professional Growth & Development: Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you’re interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at https://www.northwestern.edu/hr/learning/index.html to learn more.
Northwestern requires all staff and faculty to be vaccinated against COVID-19, subject to limited exceptions. For more information, please visit our COVID-19 and Campus Updates website.
The Northwestern campus sits on the traditional homelands of the people of the Council of Three Fires, the Ojibwe, Potawatomi, and Odawa as well as the Menominee, Miami and Ho-Chunk nations. We acknowledge and honor the original people of the land upon which Northwestern University stands, and the Native people who remain on this land today.
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. Click for information on EEO is the Law.
Bachelor’s Degree or equivalent degree in relevant academic field.
CIP and/or CIM eligible.
5+ years of relative experience including demonstrated knowledge of federal, state, and local regulations governing the participation of human subjects in research.
Demonstrated characteristics: adaptability, agility, coaching, collaboration, collegiality, customer focus, ethics and integrity, judgment, and multi-tasking.
Desire to advance professional career in the IRB Office.
Minimum Competencies: (Skills, knowledge, and abilities.)
Competencies: Computer proficiency, report writing, group management, organization and research regulations.
Demonstrated written and oral communication skills and ability to initiate and compose correspondence to investigators and to produce accurate written reports of IRB decisions and the decision making process.
Demonstrated working knowledge of medical behavioral research terminology.
Ability to work independently and as part of a team in a fast paced and highly stressed environment.
Possess exemplary interpersonal and time management skills.
Ability to communicate clearly in writing, in person, and by telephone.
Terminal degree in related academic field.
CIP and/or CIM professional certifications are strongly preferred.
Preferred Competencies: (Skills, knowledge, and abilities)
Knowledge of government and institutional regulations, as well as the ethical principles in the Belmont Report, in order to understand and explain the reasons for the requirements of OPRS and 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.
Founded in 1851, Northwestern University is committed to excellent teaching, innovative research, and the personal and intellectual growth of its students in a diverse academic community. Northwestern uniquely combines the assets of several different types of academic institution – the power of a major research university, the creative energy of arts and music conservatories, the intimacy of a liberal arts college, the rich diversity of an international institution, exceptional professional schools, and the excitement of a Big Ten athletic program. The University combines innovative teaching and pioneering research in a highly collaborative environment that transcends traditional academic boundaries.The Office for Research (OR), led by Northwestern’s Vice President for Research, plays a key role in achieving the University’s objectives set forth in the strategic plan by working with faculty and University leadership to refine the strategy and implement the tactics necessary to meet the goals in the University strategic plan. The Institutional Review Board Office (IRB Office) is the lead unit at Northwestern University responsible for operationalizing the University's Human Resea...rch Protection Program (HRPP). The IRB Office's mission is to ensure that the IRB review process is efficient and effective in its primary function of protecting individuals involved in University engaged research. The IRB Office ensures that HRPP operations and human research studies are conducted in accordance with all federal, state, local, institutional, and accreditation requirements.Benefits:At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at https://www.northwestern.edu/hr/benefits/index.html to learn more.Work-Life and Wellness:Northwestern offers comprehensive programs and services to help you and your family navigate life’s challenges and opportunities, and adopt and maintain healthy lifestyles.We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at https://www.northwestern.edu/hr/benefits/work-life/index.html to learn more.Professional Growth & Development:Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you’re interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at https://www.northwestern.edu/hr/learning/index.html to learn more.Northwestern requires all staff and faculty to be vaccinated against COVID-19, subject to limited exceptions. For more information, please visit our COVID-19 and Campus Updates website.The Northwestern campus sits on the traditional homelands of the people of the Council of Three Fires, the Ojibwe, Potawatomi, and Odawa as well as the Menominee, Miami and Ho-Chunk nations. We acknowledge and honor the original people of the land upon which Northwestern University stands, and the Native people who remain on this land today.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.