IRB Specialist

• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Salary Range: $65,000 - $75,0000

Position Summary

The IRB Specialist of the Columbia University Human Research Protection Office (HRPO) has the primary responsibility for providing subject matter expertise in the review of human subject research. The IRB Specialist reports to an IRB Senior Specialist, or a Director within the IRB Management team. The IRB Specialist, working collaboratively with a team of other professionals, is primarily responsible for ensuring research protocols submitted for IRB review are assessed in an efficient manner for completeness, accuracy, and level of review according to applicable regulation and/or institutional policy; ensuring regulatory support is provided to one or more Columbia IRBs, each of which have a large portfolio of research; coordinating convened, bi-weekly IRB meetings for review of research, as applicable; and serving as a resource for the Columbia research community, IRB Chairs and Members and the HRPO.

Responsibilities

Core responsibilities:

• Review protocol-specific events submitted for IRB review:
  
  
  
  • Perform a detailed, independent regulatory and administrative review, document submission-specific findings, identify regulatory items for reviewers, and advise as to whether the requirements for IRB approval have been met;
  • Recommend the appropriate level of review for assigned research submissions;
  • Generate notifications to researchers regarding the outcome of the review;
  • Evaluate researchers' responses to IRB requests;
  
  
  
  

• Independently apply the framework of applicable federal regulations, laws, guidance, and CU IRB policies and procedures to assigned reviews;
• Advise the research community about human subjects protection issues and institutional policies.

• Maintain and further develop personal knowledge about applicable statutes, policies and procedures governing human subject research and related ethical codes and guidelines; continuously interpret and apply these requirements to IRB submissions and ongoing research activities;
• Notify designated HRPO staff when guidance and/or policies require updating, including identification of policy/guidance gaps;
• Participate in HRPO-led as well as self-motivated continuing education initiatives;
• If supporting a Columbia IRB that holds convened meetings, additional responsibilities include:
  
  
  
  • Manage pre-, intra- and post-meeting activities in partnership with the respective Manager and IRB Chair, including agenda management, meeting facilitation and all aspects of IRB meeting documentation;
  • Provide technical support and guidance on regulatory matters during convened IRB meetings.
  
  
  
  

Duties common to all HRPO staff:

• Serve on committees constituted to improve the functioning and climate of the HRPO.
• Maintain awareness of institutional entities, policies, and relationships that affect HRPO and IRB operations.
• Develop positive relationships with researchers and colleagues throughout olumbia to facilitate compliance and greater efficiency of HRPO and IRB processes.
• Participate in evaluation of enhancements or other modifications to the IRB module of the Columbia research administration system.
• Other work as assigned.

Core competencies necessary for success:

• Applied Learning - Assimilates and applies job-related information in a timely manner; puts new knowledge, understanding, or skill to practical use on the job.
• Client Focus - Makes clients and their needs a primary focus of one's actions; develops and sustains productive client relationships.
• Initiating Action - Takes prompt action to accomplish objectives; takes action to achieve goals beyond what is required; is proactive.
• Communication - Clearly conveys information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand and retain the message.

Minimum Qualifications

(Applicant MUST meet these minimum qualifications to be considered an applicant):

• Requires a bachelor's degree or equivalent, plus three years of related experience of which two years should be direct IRB and/or research experience.
• The successful candidate will demonstrate:
  
  
  
  • Strong organizational and time management skills to support a large volume of submissions, review deadlines, and researcher expectations while maintaining a high degree of accuracy and attention to detail;
  • Strong decision making skills and demonstrated ability to assess multiple issues analyitically in order to apply knowledge of federal regulations and institutional policy to variety of complex situations and research protocols;
  • Ability to make accurate and appropriate independent judgments, including when to escalate issues, and able to accept direct supervision;
  • Excellent interpersonal and written communication skills;
  • Self-motivation to function independently in a high intensity environment often driven by deadlines;
  • Ability to work collaboratively in a positive and effective manner;
  • Familiarity with state and federal regulations related to human subjects protection;
  
  
  
  

• Solid computer skills and strong competency in Microsoft Office Professional software, Zoom, and Microsoft Teams.

Preferred Qualifications

• Experience with biomedical, behavioral, and/or social sciences human research; knowledge of international ethical codes and regulations governing protection of human subjects in research; experience with electronic administration systems; and certification as an IRB professional are preferred qualifications.

Equal Opportunity Employer / Disability / Veteran

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