Senior Irb Specialist

• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Salary Range: $80,000-$95,000

Position Summary

The Senior IRB Specialist- Manager of the Columbia University Human Research Protection Office (HRPO) reports to the Assistant Director for IRB Management or an IRB Senior Specialist - Senior Manager.

The Senior IRB Specialist-Manager, working collaboratively with a team of other professionals, is primarily responsible for managing a CU IRB with a large portfolio of research to oversee team functionality; provide regulatory guidance and support to IRB members; serve as a resource for the CU research community; and develop HRPO Staff.  

Responsibilities

• • Review protocol-specific events submitted to the IRB:
    • 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;
    • Generate notifications to researchers regarding the outcome of the review;
    • Evaluate researchers' responses to IRB requests;
  • Work with other HRPO officers of administration to ensure uniformity of review and compliance with IRB standard operating procedures, applicable policies, and applicable federal, state and local statutes. 
  • 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 CU IRB that holds convened meetings, additional responsibilities include:
    • Manage pre-, intra- and post-meeting activities in partnership with the respective IRB Chair and other ancillary review committees when applicable; Including agenda management, meeting facilitation and all aspects of IRB minutes documentation;
  • Provide lead regulatory support during convened meetings;
    • Ensure that IRB meeting minutes are in compliance with federal regulatory standards and institutional requirements and provide feedback if the IRB should meet with greater frequency.
  • Provide technical support and guidance on regulatory matters during convened IRB meetings.
  • Conduct quality control functions for the; this  may extend to all areas of the operation including review of files and meeting minutes for completeness, accuracy and consistency;
  • draft, edit and issue approval letters to PIs
  • Apply strong organizational skills and effective teamwork skills to assist in management of a large volume of submissions, deadlines, and customer expectations;
  • Assist with policy and guidance revision;
  • Participate in the orientation and training of HRPO personnel, including peers and serves as a resource to peers when needed in support of efficiency and effectiveness of IRB operational activities;
    • Manage a large volume of research protocols and related submissions, from assignment through IRB approval, and ensure high level of quality and uniformity of review of these protocols.
    • Lead the designated IRB team to meet HRPO's expectation for quality, productivity and goal accomplishment; encourage IRB specialist contribution and provide feedback.
    • Supervise and train direct report(s) to provide administrative and regulatory support to one IRB in accordance with HRPO's policies and procedures.
    • Train direct report and/or ensure direct report is trained in accordance with the core educational program that is required for research personnel.
    • Assign tasks to team members supporting one IRB to ensure that the following is conducted:
    • Conduct a detailed independent analysis of protocol specific events submitted for IRB review, document submission-specific findings and generate notification regarding the outcome of the review;
  • Evaluate PI responses and identify regulatory items for IRB reviewers; advise as to whether or not the requirements for IRB approval have been met;
  • Evaluate performance of direct report(s) at least annually.
  • Participate in the evaluation of the IRB Chairs and members.
  • Guide IRB Chairs and IRB reviewers with the application of regulatory requirements and provide them with the necessary information to conduct their reviews.
  • Train new IRB members on how to use the CU electronic review system (Rascal) and facilitate onboarding.
  • Ensure the accuracy of the records generated by the administrative team, Chair and IRB reviewers.
  • Serve as a voting member of the IRB they support and other CU IRBs as needed.
  • As applicable, assign events to primary reviewer(s) as designated by the IRB Chair.
  • Maintain basic records of direct report(s) such as onboarding & training records, time-off tracking sheets, performance evaluation, telecommuting and flexible arrangement forms in accordance with HRPO process.
  • Provide feedback to the Assistant Director or Senior Manager, as applicable, regarding team performance, need for personnel, procedural changes and IRB issues.
  • Work with supervisor and other managers to recruit, interview and select IRB specialists or senior IRB specialists.

   Duties common to all Senior IRB Specialists:

  • Serve on committees constituted to improve the functioning 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 CU to facilitate compliance and greater efficiency of HRPO and IRB processes.
  • Participate in the testing of electronic submission system updates
  • 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.
  • Stress Tolerance  - Maintains stable performance under pressure; stays focused on work tasks and productively uses time and energy when under stress; presents a positive disposition and maintains constructive interpersonal relationships when under stress
  • Client Focus - Makes clients and their needs a primary focus of one's actions; develops and sustains productive client relationships.
  • Managing Work - Effectively manages one's time and resources to ensure that work is completed efficiently.
  • 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.
  • Strategic Decision-Making - Obtains information and identifies key issues and relationships relevant to achieving a long-range goal or vision; commits to a course of action to accomplish a long-range goal or vision after developing alternatives based on logical assumptions, facts, available resources, constraints, and university values.
  • 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.
  • Coaching:  Provides instruction and positive role models to help others develop skills.
  • Monitors the results of delegations, assignments, or projects, considers the skills, knowledge, and experience of the assigned individual and the characteristics of the assignment or project.
  • Building a Successful Team - Uses appropriate methods and a flexible interpersonal style to help build a cohesive team; facilitates the completion of team goals.
  • Focusing on results - Establishes courses of action for self and others to ensure that work is completed efficiently.
  • 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.

Minimum Qualifications

Requires a bachelor's degree or equivalent, plus four 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 analytically in order to apply knowledge of federal regulations and institutional policy to variety of complex situations and research protocols;
• Excellent interpersonal and written communication skills;
  • Ability to make accurate and appropriate independent judgments, including when to escalate issues, and able to accept direct supervision;
• Ability to work collaboratively in a positive and effective manner;
• Solid computer skills and strong competency in Microsoft Office products.
  • Self-motivation to function independently in a high intensity environment often driven by deadlines;
  • Comprehensive knowledge of state and federal regulations and familiar with policies, guidelines and ethical codes related to the protection of human subjects in research.

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; certification as an IRB professional and experience supervising staff are preferred qualifications.

Equal Opportunity Employer / Disability / Veteran

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