Job Details

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Teachers College, Columbia University
  • Position Number: 3926073
  • Location: New York, NY
  • Position Type: Laboratory and Research

Quality Assurance & Education Specialist


Posting Summary:
The Institutional Review Board (IRB) Office at the Teachers College (TC) functions to ensure that all human subject research conducted at the University is in compliance with applicable laws, regulations, and University policies. The IRB Office supports the Institutional Review Board and provides education and training on human subject research.

In support of TC's mission and vision, the IRB is seeking a Quality Assurance & Education Specialist facilitates the proper conduct of human subjects research throughout TC. The position requires advanced knowledge of research regulations, guidance, and best practice standards as well as the ability to apply this knowledge across a diverse portfolio of research.


Job Summary/Basic Function:
The Quality Assurance & Education Specialist role requires advanced knowledge of research regulations, guidance, and best practice standards as well as the ability to apply this knowledge across a diverse portfolio of research.


CHARACTERISTIC DUTIES AND RESPONSIBILITIES:


The incumbent will develop and implement training and educational programs for investigators, research staff, faculty mentors/students and the Institutional Review Board (IRB) members and staff; serves as an expert resource by providing mentoring and targeted support to investigators, IRB Chairs, members, and staff in the development, implementation, and oversight of research; and performs quality assurance monitoring of research protocol and IRB activities to ensure that the conduct and oversight of human subjects research is in compliance with regulations and in accordance with professional standards. This proactive approach is intended to minimize risks to human subjects as well as regulatory risks at the investigator and institutional level.


Education/Training:



  • Develop and provides core and targeted training for IRB members and staff, investigators, and research staff.

  • Assist investigators, the IRB office, and other stakeholders in preparations for external audits and inspections by sponsors, grantors, accrediting bodies, and regulatory authorities.

  • Provide training on expectations around the preparation and organizations.

  • Partner with the IRB Director and others to develop, implement, and continuously refine the human subject research educational plan.

  • Interacts with external auditors or inspectors.

  • Monitor findings from internal QA/QI activities to identify trends and issues that may inform education and training needs.

  • Monitor changes to relevant federal and state regulations and guidance documents to inform education and training needs.

  • Interact and coordinate with other units to facilitate a comprehensive, accessible research education program.

  • Coordinate with external vendors such as CITI and PRIM&R to ensure that required training are available and up to date.



Quality Assurance/Quality Improvement



  • Ability to maintain quality assurance (QA) and measure compliance against certain necessary standards, typically focused on individual people or projects.

  • Ability to maintain quality improvement (QI) as a continuous improvement process focused on processes, groups, and systems.

  • Monitor TC research and IRB activities for compliance with applicable federal regulations and guidelines, IRB requirements, and TC policies and procedures.

  • Conduct routine and for-cause QA audits of studies at the investigator level, in accordance with the QA/QI Plan, to assure compliance with IRB policies and federal regulations and guidelines.

  • Report potential serious or continuing non-compliance with applicable regulations or institutional policies to the IRB Director, IRB, and other institutional leaders as appropriate.

  • Partner with the IRB Director, Research Compliance Analyst, and others to develop, implement, and continuously refine the IRB Quality Assurance/Improvement (QA/QI) program.

  • Provide support and guidance to investigators and staff throughout the course of external audits or inspections.

  • Attend entrance and exit interviews for audits by external entities at the request of the IRB Director, investigators or others as appropriate.

  • Assist investigators and the IRB with the development of Corrective and Preventive Action (CAPA) Plan development as warranted.

  • Monitor regulatory reports and other sources of information to identify trends and areas of potential risk.

  • Track and report on internal QA/QI activities to identify trends and areas of potential risk as well as to inform the overall IRB QA/QI Plan.

  • Develop reports and make recommendations to the IRB Director and others to enhance quality and mitigate risk.

  • Assess and monitor various sources of data (e.g., IRB electronic system) that are or could be utilized to track and report on research and review activities.


Minimum Qualifications:



  • Bachelor's degree in research or education related field

  • 3 years' experience in IRB operational procedures

  • Excellent organizational skills, managing conflicting demands and priorities, without compromising quality

  • Demonstrated accuracy and thoroughness

  • Ability to work independently; effectively balance team and individual responsibilities

  • Ability to utilize common software such as Word, Excel, Access, PowerPoint, SharePoint; ability to learn new software as required and remain proficient in all programs necessary to perform duties of this position

  • Strong professional communication and public speaking skills


Preferred Qualifications:



  • Masters' degree in research or education related field

  • 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

  • Certification or eligibility to sit for Certification Exam for Certified IRB Professional (PRIM&R).


Salary Range:


$84,280-$95,000


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).



If you would like to request any disability related accommodations to complete the job application or to participate in the interview process, please email:oasid@tc.columbia.edu.



Equal Employment Opportunity


Teachers College is committed to fostering a diverse and inclusive academic community and to providing equal opportunity in employment. All qualified applicants will receive consideration regardless of race, color, sex (including pregnancy, gender identity or gender expression), religion, creed, national origin, age, citizenship, disability, marital status, sexual orientation, veteran status, or any other legally protected status.



To apply, please visit: https://employment.tc.columbia.edu/en-us/job/510990/quality-assurance-education-specialist






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