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 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 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.

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.

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.

• 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

The goal of the following activities is to ensure high quality services for Northwestern University’s researchers, staff and students involved with human research subjects processes and procedures. The IRB Reliance Analyst is expected to be able to:

• 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.
• Performs other duties and responsibilities as assigned.

Minimum Qualifications:

• 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:

• 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.