IRB Reliance Analyst

Northwestern University; Chicago (IL); On-site; USD 69,000 - 78,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Disability insurance

Life insurance

Paid vacation

Holidays

Tuition benefits

Commuting pre-tax

Flex spending accounts

Retirement savings options

Wellness programs

Job summary

The IRB Reliance Analyst at Northwestern University coordinates IRB Reliance activities, serving as a liaison among the IRB Office, investigators, study sites, and external IRBs to ensure compliant reliance processes.

You will analyze regulatory requirements, track metrics, support training, and lead special projects to advance the Office for Research mission and uphold Northwestern's values of empathy, accountability, fairness, and collaboration.

Qualifications

• Bachelor's degree or equivalent in a relevant field.
• Minimum of 2+ years’ experience with human subjects research and compliance.
• CIP and/or CIM eligible within a year.
• Strong adaptability, collaboration, and integrity in fast-paced environments.

Responsibilities

• Coordinate IRB reliance activities and liaise with internal and external IRBs.
• Work with Northwestern's legal counsel to address reliance agreements and requirements.
• Provide guidance to investigators on the reliance process and eIRB+ requirements.
• Provide administrative support and track metrics for reliance processes.
• Assist with training and development of resources for the reliance process.
• Lead special projects for the IRB Office.

Skills

Regulatory knowledge

Collaboration

Communication

Analytical thinking

Time management

Ethics and integrity

Problem solving

Education

Bachelor's Degree or equivalent in a relevant field

Tools

Huron's Click IRB

HRPP Toolkit

Job description

Department: IRB Office
Salary/Grade: EXS/7

Job Summary: Coordinates IRB Reliance activities, which include assisting with managing relationships between Northwestern University and outside/external IRBs. In addition, this position works in collaboration and consultation with IRB Office staff to identify process improvement needs as related to IRB Reliance activities to meet and further Northwestern University's Office of Research mission.

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

Specific Responsibilities:

• Serve as liaison between Northwestern University IRB, Principal Investigators, research study sites, individual study teams and external organizations and IRBs regarding IRB Reliance issues.
• Work with the Northwestern University legal counsel to address legal and Institutional requirements related to reliance agreements and the reliance process.
• Provide guidance and assistance to investigators regarding the reliance process and eIRB+ application requirements.

Analysis

• Provide administrative support to the Northwestern IRB Office related to IRB reliance activities.
• Track and analyze reliance process metrics for presentation to IRB and Office for Research Leadership.
• Assist IRB Office staff, chairs, members, and researchers with identifying regulatory agency requirements surrounding reliance.

Training

• Assist with training as necessary for the Reliance Agreement process to IRB Office staff, the Northwestern research community and external stakeholders.
• Provide support in the development of research community resources for the reliance process.

Other

• Leads and participates in special projects for the office.

Minimum Qualifications: (Education, experience, and any other certifications or clearances)

• Bachelor's Degree or equivalent degree in relevant academic field.
• 2+ years of relative experience including demonstrated knowledge of federal, state, and local regulations governing the participation of human subjects in research.
• CIP and/or CIM eligible within a year.
• Demonstrated characteristics: adaptability, agility, coaching, collaboration, collegiality, customer focus, ethics and integrity, judgment, and multi-tasking.

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
• Experience with Huron's Click IRB software and HRPP Toolkit.
• 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 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.
• Ability to assess risk.

Target hiring range for this position will be between $69,000-$78,000 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.