Careers in Quality

Northwestern University's IRB Office is rapidly expanding and is bolstering its infrastructure with additional staff positions to increase headcount. 

The IRB Reliance Analyst Lead is responsible for the implementation and management of a robust IRB Reliance agreement process and serves as the lead for managing relationships between Northwestern University and outside/external IRBs. This position works in collaboration and consultation with the IRB Office Directors and IRB Managers, to identify process improvement needs as related to the IRB Reliance program to meet and further Northwestern University’s Office for Research mission. The IRB Reliance Lead performs all job functions in alignment with Office for Research Values (Empathy, Accountability, Fairness, Community and Creativity) and works to foster these values within the IRB Office and the Office for Research. 

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.

• Serves as a key liaison between Northwestern University IRB, Principal Investigators, clinical study sites, individual study teams and external organizations and IRBs regarding IRB reliance issues.
• Communicates with federal regulatory agencies, such as the Food and Drug Administration, Office of Human Research Protections and funding agencies such as National Institutes of Health and Industry sponsors regarding IRB reliance issues and provides regulatory and policy guidance to IRB members and staff as needed. 
• In collaboration with IRB Reliance Manager develops policies, guidelines and procedures related to the IRB reliance process when Northwestern is serving as the reviewing IRB or the relying IRB.
• Serves as a subject matter expert in state, local, and federal laws and regulations as they apply to human research.

Analysis

• Provides analytical and administrative support to the Northwestern IRB related to IRB reliance.
• With IRB Directors and IRB Managers, participates in HRPP evaluation, strategic planning and formulations of goals and objectives.

Training

• Provide training as necessary for the Reliance Agreement process to IRB staff, the Northwestern research community and external stakeholders.

Other

• Leads and participates in specials projects for the office.
• Performs other duties and responsibilities as assigned.

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. Click for information on EEO is the Law.

Minimum Qualifications:

• Bachelor’s Degree or equivalent degree in relevant academic field.
• CIP eligible.
• 5+ years of relevant experience including demonstrated knowledge of federal, state, and local regulations governing human research.
• 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 human research.
• Demonstrated competencies:  computer proficiency, report writing, and human 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:

• Master’s degree or equivalent in a relevant academic field.
• Certification as an IRB professional (CIP)
• Active participation in the community of IRB professionals
• Experience with Huron’s 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
• Ability to assess risk.