Under general direction of the Exec Dir IRB Office, the 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.
Please note: Will require travel between Chicago and Evanston campuses. This position will occasionally require the incumbent to be available to work on weekends and after normal working hours. The position requires multi-tasking in a customer service setting where there may be multiple demands on the individual’s time. Successful incumbents must maintain professional demeanor in order to ensure resolution. Response times for voice mail and e-mail inquiries must be minimal.
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.
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.
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: 40132
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.