The Director for Institutional Review Board (IRB) Management (DIM) within the Human Research Protection Office (HRPO) of Columbia University (CU) reports directly to the Executive Director (ED) of the HRPO, and is responsible for ensuring that the routine operations of the IRBs and the Administrative Review Committee (ARC) are conducted in an efficient, effective, and compliant manner. Under the direction of the ED, the successful candidate will work closely with the Director for Operations and Director for Compliance Oversight to manage shared aspects of the HRPO program for the protection of human subjects in research, including but not limited to central IRB processes, IRB membership, QA/QI initiatives, procedures for addressing noncompliance or improving compliance, and office websites.
Supervise the Assistant Director for IRB Management (ADIM) and Senior Managers, each of whom have responsibility for one or more individual IRB(s) and/or activities of the ARC.
Provide consultation on application of DHHS, FDA and other applicable regulations and statutes for the protection of human subjects to specific research situations.
Evaluate performance of direct reports at least annually.
Assume a primary role in hiring replacements or promoting direct reports and their subordinate staff, including revision of job descriptions when necessary.
Work with the ADIM and Senior Managers to effectively handle personnel actions with their subordinate staff, e.g., evaluation, replacement, promotion, or management of performance concerns.
Oversee the routine operations of the IRBs and ARC.
Ensure that IRB meeting schedules are drafted, review and work with the ADIM and IRB Chairs to approve IRB meeting schedules, ensure that schedules are posted in a timely manner, review schedule changes with the ADIM, document and post schedule changes.
Evaluate and work with IRB Chairs and the ADIM to implement membership changes for the IRBs, ensuring that constitution of each Board meets regulatory and institutional requirements.
Work with the Director for Operations to initiate and obtain institutional approval for membership changes following approval by the Executive Director.
Ensure that rosters are maintained in a current and accurate manner by managers.
Work with the Director for Operations to ensure that Federalwide assurances and IRB registrations are maintained in a current and accurate manner.
Participate in annual evaluation of IRB Chairs and members.
Continually assess efficiency and effectiveness of policies and procedures for review of submissions to the IRBs and ARC.
Conduct basic quality assurance assessments to inform decisions regarding procedural and policy effectiveness, and identify whether there is a need for change.
Implement minor changes; draft proposals for major changes for review and approval by the Executive Director.
Recommend policy changes to the Executive Director, Policy Committee, and/or Accreditation Committee, as appropriate and in accordance with office Standard Operating Procedures (SOPs).
Initiate special projects designed to enhance office procedures, IRB performance, or overall human subjects protections.
Take a lead role in maintaining and updating SOPs that pertain to routine operations of the IRBs and ARC.
Request higher level or time-intensive Quality Assurance (QA) and Quality Improvement (QI) assessments to be conducted under the direction of the Director for Operations and related staff, and evaluate results, including periodic assessments of:
Timeliness of reviews;
Quality of reviews;
Analysis of metrics;
IRB meeting minutes;
Staff pre-reviews of protocol submissions.
Ensure that IRB meeting minutes are being processed timely under the direction of managers and meet regulatory requirements.
Interface with researchers to improve processes or assess concerns, striving to maintain a collaborative relationship to facilitate the shared goal of conducting ethical human research.
If warranted, evaluate resultant need for change in procedure, performance improvement, or education/training
Represent the HRPO on institutional committees and workgroups for which the focus is directly related to the DIM primary responsibilities.
Chair Education and Training Committee (subcommittees may be delegated)
Duties common to all HRPO Officers of Administration:
Conduct pre-reviews of submissions (new protocols, modifications, renewals, reports of unanticipated problems, termination requests) as needed.
Serve on committees constituted to improve the functioning of the IRB office.
Maintain awareness of institutional entities, policies, and relationships that affect IRB functioning.
Interact with investigators to facilitate efficient review of submissions.
Work with other HRPO officers of administration and staff to ensure uniformity of review and compliance with IRB standard operating procedures and applicable federal and state regulations.
Maintain up to date knowledge of state and federal regulations as well as policies, guidelines and ethical codes related to the protection of human subjects in research.
Other work as assigned.
This position requires a bachelor's degree or equivalent in education and experience plus at least 5 years of direct IRB administrative experience, with such experience including review and processing of biomedical research protocols.
Applicant MUST meet these minimum qualifications to be considered an applicant:
Supervisory or management experience.
In depth knowledge of federal, state and local laws and regulations and industry requirements and practices regarding the proper conduct of human research.
Poised, mature and professional to work with a variety of personalities within the University, at other research institutions and at federal regulatory agencies.
Demonstrable ability to collaborate with partners in research, i.e., investigators and coordinators.
Excellent written and verbal communication skills, and strong proofreading skills.
Detail oriented, with superior organizational skills and able to manage and prioritize a variety of projects at once.
Resourceful, proactive, and thorough, having a focused, self-starting attitude with the ability to work independently and as a member of the team.
Solid computer skills and strong competency in Microsoft Office products.
Experience in implementation of education and training initiatives, and QA/QI activities, is preferred. Familiarity with IRB review of social science, public health, behavioral, and/or humanities research is beneficial, as is experience in a clinical research environment. Certification as an IRB professional is a plus.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 507455
About Columbia University
Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.