IRB Compliance Analyst

Department: IRB Office
Salary/Grade: EXS/7

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

Job Summary:

Under direct supervision, the IRB Compliance Analyst ensures that the various research compliance activities and programs within Northwestern University adhere to Federal and State regulations and institutional policy. Assists with compliance activities, including post-approval monitoring and investigations; and helps organize and implement the confidential review and monitoring processes of research activities involving human participants. The IRB Compliance Analyst will also assist in implementing new procedures or policies to ensure that the IRB panels and Northwestern research community operate at optimum effectiveness and efficiency. In addition to the activities mentioned above, this position collaborates and consults with IRB Office staff to identify process improvement needs related to IRB Compliance activities to meet and further Northwestern University's Office of Research mission.

The IRB Compliance Analyst must have the ability to function independently in decision-making with regard to project review and helping the research community and colleagues with compliance-related issues and activities.

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

Please note: Will require travel between Chicago and Evanston campuses. 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 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 Office:
  • Serves as liaison between Northwestern University IRB, Principal Investigators, individual study teams and the IRB Office regarding human research compliance issues.
  • When needed, engages with members of the Northwestern University Human Research Protections Program (HRPP) to address legal and institutional requirements related to compliance review.
  • Disseminates information about and assists investigators in the preparation of responses to compliance related queries to ensure that required elements are addressed and that all documents are prepared in accordance with appropriate standards.
  • Assists with the development of quality assurance initiatives, as well as other special projects as needed.

Analysis

• Provides administrative/operational support to the Northwestern IRB Office related to IRB compliance activities.
• Tracks compliance process metrics for presentation to IRB and Office for Research leadership.
• Assists IRB Office staff, chairs, members, and researchers with identifying regulatory agency and good clinical practice requirements surrounding compliance.

Training

• Assists with training as necessary on the ethical conduct of research involving human participants to IRB Office staff and the Northwestern research community.
• Provides support in the development of research community tools and resources for the ethical conduct of human research.
• Provides appropriate resources and guidance to investigators and study teams, including regulatory interpretation, guidance documents, and ethical principles.
• Participates in professional development activities, workshops, and conferences as appropriate.

Other

• Participates and actively engages in special projects for the office.

Miscellaneous

Performs other duties as assigned.

Minimum Qualifications:

• Bachelor's Degree or equivalent degree in relevant academic field.

• Eligible for Certified IRB Professional (CIP) exam.

• 2+ years of relative 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 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.

• Possesses interpersonal and time management skills.

Preferred Qualifications:

• CIP Certification

• Experience with Huron's Click IRB software and HRPP Toolkit.

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 demonstrate assertiveness appropriately in IRB meetings, audits/investigations 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 research.

• Ability to assess risk.

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 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.