The IRB Specialist of the Columbia University Human Research Protection Office (HRPO) reports to an IRB Senior Specialist-Manager. 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 a CU IRB with a large portfolio of research; coordinating convened, bi-weekly IRB meetings for review of research, as applicable; serving a resource for the CU research community, IRB Chairs and Members and the HRPO.
- 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 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 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 greater efficiency of HRPO and IRB processes.
- 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.
- Review protocol-specific events submitted to the IRB:
- Requires a bachelor’s degree or equivalent in education and experience, plus three years of related experience of which two years should be with 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 (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;
- 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 products.
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.