Senior IRB Specialist

• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Standard Work Schedule: 9am - 5pm
• Salary Range: $80,000-$95,000

Position Summary

The Review Board (IRB)/Manager, reports to the Assistant Director for IRB Management of the Columbia University Human Research Protection Office (HRPO).

The Senior IRB Specialist is responsible for the management of a substantial portfolio of research protocols submitted for IRB review, facilitating regulatory support to a CU IRB and ensuring the respective IRB is in compliance with all federal regulatory and local requirements and accreditation standards. This staff member will join other professionals who are responsible for management of the IRB operation.

Responsibilities

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  Core responsibilities

  
  
  
  
  • 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
  • Ensure research protocols submitted for IRB review are in compliance with CU IRB standard operating procedures (SOPs) and institutional policies as well as applicable federal and state regulations
  • 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
  • Ensure direct report(s) assess research protocols for completeness, accuracy, and level of review according to applicable regulation and/or institutional policy in an efficient manner
  • Train direct report and/or ensure direct report is trained in accordance with the core educational program that is required for research personnel. Participates in the orientation and training of other HRPO personnel, including peers;
  • Assign tasks to team members supporting one IRB to ensure that the following is conducted:
  
  
  
  
  • A detailed independent analysis of protocols specific events submitted for IRB, document submission-specific findings and generate Principal Investigator (PI) 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 team, Chair and IRB reviewers
  • If responsible for supporting a CU IRB that process protocols to be reviewed by the convened IRB:
  
  
  
  
  • Ensure the organization of convened IRB meetings for review of research as per HRPO pre-determined schedule or more frequently when determined to be necessary.
    
    
    
    • Manage pre-meeting, meeting and post-meeting activities of the convened IRB in partnership CU IRB Chair and other ancillary review committee when applicable; Includes agenda management, meeting facilitation and all aspects of IRB minutes documentation;
    • Provide regulatory expertise during convened meeting at IRB Meetings
    • Ensure that IRB meeting minutes are in compliance with federal regulatory standards and institutional requirements
    
    
    
    
  • Work closely with IRB Chair to provide administrative and regulatory support in the review and processing of submissions
  
  
  
  
  • Conduct quality control functions for the HRPO that may extend to all areas of the operation including review of files and meeting minutes for completeness, accuracy and consistency;
  • Serves as a resource for the CU research community and other HRPO staff
  • 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 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 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.
  • Maintains and further develop knowledge about the federal and state regulations governing human subject research and related institutional policies and procedures; continuously interprets and applies these requirements to human subject research protocols and ongoing research activities
  • Notify supervisor and respective Director when guidance and/or policies require updating; Includes identification of policy/guidance gaps and assistance with policy and guidance revision
  • Participate in HRPO-led as well as self-motivated continuing education initiatives;
  
  
  
  

  Duties common to all Senior IRB Specialists:

  
  
  
  
  • Serve on committees constituted to improve the functioning of the IRB office.
  • Participate in the testing of Rascal updates
  • Maintain awareness of institutional entities, policies, and relationships that affect IRB functioning.
  • Develop positive relationships with researchers and colleagues throughout CU to facilitate greater efficiency of HRPO processes.
  • 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.
  
  
  
  

  Core competencies necessary for success:

  
  
  
  
  • Building a Successful Team - Uses appropriate methods and a flexible interpersonal style to help build a cohesive team; facilitates the completion of team goals
  • Managing Work - Effectively manages one's time and resources to ensure that work is completed efficiently; 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.
  • Applied Learning & Coaching - Assimilates and applies job-related information in a timely manner; puts new knowledge, understanding, or skill to practical use on the job; provides instruction and positive models to help others develop skills;
  • 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.
  • 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.
  • 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.
  
  
  
  
  

Minimum Qualifications

• Bachelor's Degree or equivalent in education and experience plus four year of experience.
• The Senior IRB Specialist 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 organizational and time management skills to support a large volume of submissions, review deadlines, and researcher (PI) 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;
• Self-motivated to function independently in a high intensity environment often driven by deadlines. Know when to refer issues to Supervisor and have the ability to make accurate and appropriate independent judgments, but be able to accept direct supervision;
  Excellent interpersonal and written communication skills;
• Ability to work collaboratively in a positive and effective manner; Familiarity with state and federal regulations related to human subject protection required. In depth knowledge is preferred;
• Solid computer skills and strong competency in Microsoft Office products; familiarity with computerized databases preferred;
• Requires a bachelor's degree or equivalent, plus four years of related experience of which at least two years should be of direct IRB experience.

Preferred Qualifications

• Experience with biomedical, behavioral, and social sciences human research, knowledge of international ethical codes and regulations governing human subjects research, and certification as an IRB professional are preferred. Experience supervising is also preferred.

Equal Opportunity Employer / Disability / Veteran

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