IRB Analyst Senior

Department: IRB Office

Salary/Grade: EXS/8

Job Summary:

Under the general direction of the Institutional Review Board (IRB) Biomedical Manager, the IRB Senior Analyst is responsible for coordinating and overseeing the daily operations and activities associated with assigned IRB panels. This position serves as a key point of contact for IRB panel operations and is responsible for organizing and managing the confidential review and approval process for complex human subject's research to ensure the protection of participants rights, safety, and welfare.

The IRB Senior Analyst supports the effective administration of the IRB program by collaborating with institutional researchers, external research partners, and sponsors; developing, implementing, and enhancing procedures to promote the efficiency and effectiveness of IRB panel operations; and ensuring compliance with applicable federal regulations, institutional policies, and established procedures.

Additionally, the position assists with the recruitment, onboarding, training, and mentoring of IRB panel members and analysts and contributes to continuous process improvement initiatives that support the overall mission and operational effectiveness of the IRB Office.

The IRB Senior Analyst will support the OR mission and values of understanding empathy, modeling accountability, ensuring fairness, embracing community, and valuing creativity.

In-Person Attendance Expectations: Staff within the IRB Office currently have a primarily remote work schedule. There is a requirement for occasional in-person attendance for meetings, training sessions, retreats, and other institutional activities, as determined by operational needs. Advance notice will be provided whenever possible. Employees are responsible for any associated travel, transportation, lodging, or other expenses related to fulfilling these in-person attendance requirements.

Please note:

This is an exempt position requiring availability on some 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 all inquiries must be minimal.

This is a primarily remote working position; however, there may be times when the individual will be requested to physically be in the office.

Specific Responsibilities:

Operational Management

The goal of the following activities is to ensure that all operational priorities are aligned with the mission and direction of the IRB Office.

• Ensures IRB operations comply with applicable federal, state, and local laws, regulations, and institutional policies governing human subject's research. Serves as a regulatory subject matter expert, monitors changes in regulatory requirements, and recommends updates to operational procedures and Standard Operating Procedures (SOPs) to maintain compliance and efficiency.
• Independently evaluates complex research submissions, including initial applications, modifications, emergency use requests, unanticipated problems, and safety reports, to determine completeness, regulatory requirements, and appropriate levels of review. Provides regulatory, ethical, and procedural guidance to researchers and staff, including recommendations for protocol and consent document revisions.
• Oversees and coordinates assigned IRB panel activities, including agenda preparation, submission assignments, and ensuring appropriate scientific expertise and regulatory representation. Monitors quorum and voting requirements and supports the effective and efficient conduct of convened IRB meetings.
• Prepares and maintains accurate, auditable regulatory documentation reflecting IRB deliberations, determinations, and approval requirements. Facilitates effective communication among IRB members, researchers, and staff regarding submission status and review outcomes, while identifying and implementing opportunities to enhance operational processes.
• Supports the recruitment, onboarding, training, and ongoing development of IRB panel members and staff. Assesses panel member expertise to facilitate appropriate review assignments and provides guidance and mentorship to IRB Analysts to promote consistency, regulatory compliance, and quality in IRB operations.

Analysis and Training

• The goal of these activities is to ensure the delivery of high-quality, efficient, and consistent services to Northwestern University researchers and staff involved in the administrative and regulatory processes associated with human subject's research.Develops and delivers training and educational materials for IRB Chairs, members, researchers, and staff on applicable regulations, ethical principles, institutional policies, and requirements for human subject's research.
• Provides training, guidance, and mentorship to IRB Analysts and support staff on regulatory review processes, administrative procedures, and best practices to promote consistency, accuracy, and efficiency in IRB operations.
• Conducts quality assurance activities and analyzes operational metrics, including review turnaround times, submission volumes, and backlogs. Prepares reports for management and regulatory agencies to support compliance, operational effectiveness, and continuous improvement.
• Develops, reviews, and updates Standard Operating Procedures (SOPs), training resources, and operational processes to ensure consistency, regulatory compliance, and efficient IRB operations.

Other

• Provides operational support and backup to the IRB Manager, including coordination and oversight of special projects and initiatives.
• Represents the IRB Office on institutional committees and work groups addressing human subjects research administration, regulatory compliance, and operational matters.

Miscellaneous

Performs other duties as assigned.

Minimum Qualifications:

• Bachelors degree or the equivalent combination of education, training and experience from which comparable knowledge and skills can be acquired.

• CIP and/or CIM eligible within two years.

• 3+ 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 and 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.

Preferred Qualifications:

• Bachelor's or advanced degree in related academic field.

• CIP and/or CIM professional certifications are strongly preferred.

• Experience with Huron Click IRB software and HRPP toolkit.

Preferred Competencies: (Skills, knowledge, and abilities)

• Some knowledge of the Association for the Accreditation of Human Research Protection Program (AAHRPP) process, tools and requirements
• 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 the IRB.
• Ability to assert her or himself appropriately in IRB meetings and in other contexts in order to represent the IRB Office, the policies and procedures of the Office for Research, and the federal, state, and local regulations and guidance pertaining to human subject protections.

Target hiring range for this position will be between $78,500 - $90,000 per year. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data

Benefits:

At Northwestern, we are proud to provide meaningful and competitive benefits. The available benefits package for this position will include health, dental, vision, disability, and life insurance; paid vacation and holidays; paid medical/sick and parental leave; tuition benefits for the employee and dependents; pre-tax and flex spending accounts for commuting and dependent care; generous retirement savings options; and wellness programs. For a comprehensive overview of available benefits, including eligibility details, 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 University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process.