Asst Director, IRB Management

• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35

Position Summary

The Assistant Director for IRB Management reports to the Director for IRB Management of the Columbia University Human Research Protection Office (HRPO). This staff member will work with the Executive Director, Director for IRB Management and professional staff who manage the teams that provide administrative and regulatory support to the IRBs that hold convened meetings, playing a key role in ensuring consistency among the CUMC IRBs that hold convened meetings; identifying, developing and updating policies and procedures for the function of the IRBs and CUMC Human Research Protection Office. Policy development is under the direction of the Executive Director, HRPO.

Responsibilities

Specific responsibilities include:

• Managing and being a resource to the professional staff who manage the teams that provide support to the CUMC IRBs that hold convened meetings.
• Enhancing the efficiency and compliance of these IRBs.
• Identifying and suggesting solutions to issues that pertain specifically to these IRBs.
• Working closely with the Director for IRB Management to ensure that initiatives to increase efficiency and compliance of these IRBs are implemented.
• Playing a key role in development or revision of policies, procedures and forms, with the focus on those that guide the operations of these IRBs.
• Mentoring managers of these teams to facilitate efficient and high-quality performance of each team.

Other responsibilities include:

• Supervising the managers or senior officers of relevant IRBs as applicable:
  • Providing consultation on application of DHHS, FDA and other applicable regulations and statutes for the protection of human subjects to specific research situations.
  • Evaluating performance of direct reports at least annually.
  • Assuming a primary role in hiring replacements or promoting direct reports and their subordinate staff, including revision of job descriptions when necessary.
  • Working with managers and senior officers of relevant teams to effectively handle personnel actions with their subordinate staff, e.g., evaluation, replacement, promotion, or management of performance concerns.
• Conducting pre-review of submissions to CUMC IRBs.
• Providing regular feedback to the Director for IRB Management regarding performance of the CUMC IRBs that hold convened meetings (and the staff that support them), and of the need for personnel, policy, or procedural changes, and IRB issues:
  • Evaluating and working with relevant IRB Chairs, managers and assistant managers to implement membership changes for the IRBs, ensuring that constitution of each Board meets regulatory and institutional requirements.
    • Ensuring that rosters are maintained in a current and accurate manner by managers.
    • Participating in annual evaluation of relevant IRB Chairs and members.
• Working closely with the Director for IRB Management to:
  • Continually assess efficiency and effectiveness of policies and procedures for review of submissions to the relevant IRBs.
  • 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).
    • Suggest and participate in special projects designed to enhance office procedures, IRB performance, or overall human subjects protections (with the concurrence of the Director of IRB Management and Director of Operations).
  • Take a lead role in maintaining and updating SOPs that pertain to routine operations of the CUMC IRBs that hold convened meetings.
  • Suggest and with the approval of the Director for IRB Management 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.
  • 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
• Working closely with the IRB Chair(s) to provide administrative support in the review and processing of submissions.
• Representing the HRPO on relevant institutional committees and workgroups for which the focus is directly related to the position's primary responsibilities.
• Ensuring that all correspondence related to the respective IRB is accurate, appropriately formatted, and comprehensive prior to release.
• Serving on committees constituted to improve the functioning of the IRB office.
• Being aware of institutional entities, policies, and relationships that affect IRB functioning.
• Advising investigators to facilitate efficient review of submissions.
• Serving as voting member of IRB.
• Other work as assigned.

This staff member will also work with other IRB officers of administration and staff to ensure uniformity of review and compliance with IRB standard operating procedures and applicable federal and state regulations.

The Assistant Director for IRB Management will 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.

Minimum Qualifications

• Requires a bachelor's degree or equivalent, plus at least five years of direct IRB administrative experience, with such experience including review and processing of biomedical research protocols and management of IRB meetings. 
• Must have up to date knowledge of state and federal regulations and be familiar with policies, guidelines and ethical codes related to the protection of human subjects in research.
• Strong interpersonal and writing skills.
• Experience with computerized databases and word processing are essential.  

Preferred Qualifications

• Experience with biomedical, behavioral, and social sciences human research
• Knowledge of international ethical codes and regulations governing human subjects
• Certification as an IRB professional

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.