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Quality and Data Specialist

Institutional Review Board

Quality and Data Specialist

  • 525541
  • Medical Center
  • Institutional Review Board
  • Full Time
  • Opening on: May 11 2022
  • Grade 104
  • Job Type: Officer of Administration
  • Bargaining Unit:
  • Regular/Temporary: Regular
  • End Date if Temporary:
  • Hours Per Week: 35
  • Salary Range: $65,000 to $75,000

Position Summary:

The Quality and Data Specialist of the Columbia University (CU) Human Research Protection Office (HRPO)/Institutional Review Boards (IRB) reports to the Business Operations Manager of the HRPO. For individual projects, the IRB Specialist will work closely with another senior member of the office. This position will contribute to efficiency and quality control and improvement by collecting, organizing, generating, analyzing and reporting on data about all aspects of office operations.

Core responsibilities:

  • Perform quantitative and qualitative quality control functions e.g., calculating and evaluating the ‘turnaround’ time for all steps of the IRB review process, evaluating staff review notes and meeting minutes for completeness, accuracy, consistency and compliance, monitoring trends in staff use of paid time off, and assessing the distribution of studies among departments or IRBs
  • Prepare and present reports of office metrics and processes, e.g., quarterly reports of turnaround time that include charts, or flow diagram of actions in a process
  • Maintain expert knowledge of the Rascal Human Subjects module to facilitate analysis and provide basis for enhancement recommendations, document HRPO involvement in module enhancement
  • Assist with maintenance of HRPO and IRB documents, e.g., records of IRB members and membership, Standard Operating Procedures, policies, and guidance documents
  • Maintain confidential files
  • Track the progress of HRPO projects and assignments  
  • Suggest analyses that will provide insight for increased efficiency
  • Identify and recommend process improvements and promote a culture of innovation, advancement, and continuous improvement

Duties common to all HRPO Specialists:

  • Serve on relevant IRB administrative committees constituted to improve the functioning of the HRPO, such as the Policy Committee and the Education and Training Committee.
  • Maintain up to date knowledge of applicable state and federal regulations as well as policies, guidelines and ethical codes related to the protection of human subjects in research. 
  • Develop positive relationships with researchers and colleagues throughout CU to facilitate compliance and greater efficiency of HRPO and IRB processes.
  • Other work as assigned, which may include but is not limited to special projects, conducting pre-reviews of submissions to the CU IRBs, attendance at IRB meetings, and writing and editing of meeting minutes.  

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.
  • 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.
  • Work Standards - Sets high standards of performance for self and others; assumes responsibility and accountability for successfully completing assignments or tasks; self-imposes standards of excellence rather than having standards imposed.
  • Time-management - Achieves better results by organizing time effectively and utilizing self-management habits that lead to increased productivity; prioritizes and identifies more critical and less critical activities and tasks, and adjusts priorities as appropriate; ensures that high-priority work is accomplished within required timelines.
  • Integrity: Performs all tasks with honesty, authenticity, and acceptance of responsibility for one’s own actions; follows through on commitments; takes responsibility for the outcome of one’s work.
  • Contributing to Team Success & Collaboration - Actively participates as a member of a team to move the team toward the completion of goals; working effectively and cooperatively with others; establishing and maintaining good working relationships.

Minimum Qualifications for Grade

  • Requires a bachelor's degree or equivalent, plus three years of related experience of which at least two years should be of prior IRB or research experience.  
  • Familiarity with methodologies for analyzing data and conducting quality assurance activities
  • Attention to detail and ability to cross-check analyses for accuracy
  • Ability to perform high level, confidential financial and personnel tasks with discretion and independent judgment.
  • Excellent interpersonal, verbal communication and writing skills.
  • Strong knowledge of and experience with data analytic and Microsoft Office suite applications
  • Ability to work independently and collaboratively.
  • Ability to coordinate multiple projects while maintaining the highest level of detail and track projects to meet established deadlines.
  • Able to function in a fast-paced environment with minimal direction.

Preferred Qualifications

  • Experience with biomedical, behavioral, and social sciences human research.
  • Experience in higher education or other large, complex institutions.
  • Must be a motivated individual with a positive mindset and exceptional work ethic.
  • Must successfully complete systems training requirements.

Equal Opportunity Employer / Disability / Veteran

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

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