A Graduate School of Education, Health & Psychology

Posting Summary:

Teachers College, Columbia University is seeking a full-time Quality Assurance and Education Specialist to join the Human Research Protection Office and support faculty and student researchers who are engaged in human subjects research. 

Job Summary/Basic Function:

The Human Research Protection Office (HRPO) and the Institutional Review Board (IRB) at Teachers College (TC) ensure that all human subjects research conducted at the College complies with applicable federal laws, state regulations, and institutional policies. The Human Research Protection Office supports the TC IRB Chair and Board members and provides education and training on human subject research to the TC research community.

In alignment with TC’s mission and vision, the Quality Assurance (QA) & Education Specialist facilitates the ethical and proper conduct of human subjects research across the College. This role requires advanced knowledge of research regulations, guidance, and best practices, as well as the ability to apply this expertise to a diverse portfolio of education, health, and psychology research. 

CHARACTERISTIC DUTIES AND RESPONSIBILITIES:

Responsibilities are divided into two broad categories: Education and Training and Quality Assurance/Quality Improvement (QA/QI). The QA/Education Specialist serves as an institutional expert, minimizing risks to human subjects and the College through proactive training and guidance, rigorous compliance auditing, and continuous process improvement.

Candidates should be mission-driven, detail-oriented, clear and responsive communicators, and able to work effectively with a diverse group of faculty, students, and staff.

Education/Training:

• Develops and provides core and targeted training for IRB members and staff, faculty and student researchers, faculty sponsors for student research projects, and research staff.
• Assists faculty and student researchers, the TC HRPO staff, and other stakeholders in preparations for external audits and inspections by funders, accrediting bodies, and regulatory authorities.
• Partners with the Human Subjects Research Compliance Director and others to develop, implement, and continuously refine the human subject research educational plan.
• Interacts and coordinates with other offices and key stakeholders at the College and other units to facilitate a comprehensive, accessible human subjects research education program for members of the TC research community.
• Monitors findings from internal QA/QI activities to identify trends and issues that may inform education and training needs.
• Monitors changes to relevant federal and state regulations and guidance documents to inform education and training needs.
• Contributes to the review and revision of the College's human subject research policy documents.
• Updates standard operating procedures for the College's HRPP as needed.
• Coordinates with external vendors such as CITI and PRIM&R to ensure that required training is available and up to date.
• Interacts with external auditors or inspectors as needed.

• Maintains quality assurance (QA) and measures compliance against certain necessary standards, typically focused on individual people or projects.
• Maintains quality improvement (QI) as a continuous improvement process focused on processes, groups, and systems.
• Monitors TC human subjects research and TC IRB activities for compliance with applicable federal regulations and guidelines, human subject IRB requirements, and TC policies and procedures.
• Conducts routine and for-cause QA audits of human subjects research studies at the investigator level, in accordance with the QA/QI Plan, to assure compliance with IRB policies and federal regulations and guidelines.
• Reports potential serious or continuing non-compliance with applicable regulations or institutional policies to the Human Subjects Research Compliance Director, the IRB Chair and board members, the Vice Dean for Research, and other institutional leaders as appropriate.
• Partners with the Human Subjects Research Compliance Director, other HRPO staff members, and key stakeholders to develop, implement, and continuously refine the College's human subject research Quality Assurance/Improvement (QA/QI) program.
• Provides support and guidance to faculty and student researchers and staff throughout the course of external audits or inspections.
• Attends entrance and exit interviews for audits by external entities at the request of the Human Subjects Research Compliance Director, researchers, or others as appropriate.
• Assists faculty and student researchers, HRPO staff, and IRB members with the development and implementation of Corrective and Preventive Action (CAPA) Plan development as warranted.
• Monitors regulatory reports and other sources of information to identify trends and areas of potential risk.
• Tracks and reports on internal QA/QI activities to identify trends and areas of potential risk as well as to inform the staff members in the Human Subjects Research Protection Office and members of the IRB of the overall IRB QA/QI Plan.
• Develops reports and makes recommendations to the Human Subjects Research Compliance Director and institutional officials to enhance quality and mitigate risk.
• Assesses and monitors various sources of data (e.g., IRB submissions management electronic system) that are or could be utilized to track and report on research and review on human subject activities.
• Generates, summarizes, and shares IRB performance metrics with HRPO staff, TC IRB Chair and board members, and institutional leadership.

Minimum Qualifications:

• Bachelor’s degree in education, health, or psychology or the equivalent in education, training and experience.
• Minimum of 4 years of direct experience in a Human Research Protection Program, IRB office, or clinical research compliance role.
• Advanced understanding of DHHS (45 CFR 46) regulations, FDA regulations (if applicable), and ethical principles (Belmont Report) governing human subjects research.
• Knowledge and understanding of software systems used to manage IRB submissions such as the Cayuse IRB Management system or OneAegis for IRB.
• Proficiency with IRB electronic submission systems, data tracking, and learning management systems.
• Excellent organizational skills, managing conflicting demands and priorities, without compromising quality.
• Demonstrated accuracy, thoroughness, and attention to detail.
• Ability to work independently and effectively balance team and individual responsibilities.
• Excellent interpersonal skills with the ability to work collaboratively with colleagues and faculty and student researchers.
• Exceptional verbal and written communication skills, with a proven ability to explain complex concepts clearly.
• Experience preparing reports to document, summarize, and disseminate information about IRB performance metrics to leadership and members of the TC research community.
• Proficiency in Microsoft Office and Google Workspace.
• Analytical Skills: Strong ability to interpret data, identify trends, and translate metrics into actionable training initiatives. Proven ability to evaluate complex research protocols, recognize systemic compliance trends, and translate data into actionable quality improvements.

Preferred Qualifications:

• Master’s degree in education, health, or psychology.
• Advanced knowledge of Federal regulations, guidance, and practice standards for human research (45 CFR 46); and other regulations (e.g., HIPAA) that impact the conduct and IRB review of research, with the ability to apply this knowledge across a diverse portfolio of research disciplines and studies.
• Direct experience drafting or reviewing an AAHRPP self-study and participating in a successful AAHRPP site visit.
• Advanced knowledge and experience with training, implementation, and use of IRB submissions management systems.
• Prior experience leading and supporting the implementation of a new IRB management system.
• Advanced proficiency with electronic IRB management systems.
• Certification: Certified IRB Professional (CIP) or Certified Clinical Research Professional (CCRP/CCRC).
• Certification or eligibility to sit for the Certification Exam for Certified IRB Professional (PRIM&R).

Salary Range:

$90,000 - $95,000

Work Modality:

Hybrid

Competitive Compensation and Benefits 

The salary range reflects the College’s good faith and reasonable estimate of the compensation for the position at the time of the job posting.  Salary decisions are dependent on several factors including but not limited to market and organizational considerations, experience, and qualifications of a selected candidate as well as internal and external equity.

Our benefits contribute significantly to the total compensation package that includes medical, dental, vision, and supplemental insurance plans; flexible and hybrid work schedules; tuition remission; life insurance; short and long-term disability insurance; an exceptional employer retirement matching program; health savings accounts (HSA), flexible spending accounts (FSA), Public Service Loan Forgiveness eligibility, and a robust Employee Assistance Program (EAP).

Hybrid/Remote

Teachers College maintains a hybrid work environment, which provides employees with flexible work arrangements while ensuring we preserve the important aspects of our unique in-person college-campus culture. Depending on role and business needs, colleagues will either work onsite or in a hybrid model (a combination of in-office and virtual days). Employees are expected to live within a 150-mile radius of the College.