IRB Analyst, Office of Research Support and Compliance

University of Texas at Austin•Austin, TX

1d•$60,000

About The Position

The Office of Research Support and Compliance (ORSC) at The University of Texas at Austin functions to ensure that all research conducted at the University is in compliance with applicable laws, regulations, and University policies. The ORSC educates and supports the University research community with regulatory guidance concerning human subjects research (Institutional Review Board), animal research (Institutional Animal Care and Use Committee), use of biohazardous agents and use of recombinant or synthetic nucleic acids (Institutional Biosafety Committee), financial conflict of interest in research (FCOI), and research integrity education. UT Austin offers a competitive benefits package that includes: 100% employer-paid basic medical coverage Retirement contributions Paid vacation and sick time Paid holidays Eligible for telework Please visit our Human Resources (HR) website to learn more about the total benefits offered. Purpose The IRB Analyst facilitates ethical conduct of research with human subjects that is compliant with federal, state, and institutional requirements by providing resources to assist the research community. The IRB Analyst is responsible for reviewing human subjects research submissions in the area of clinical and social behavioral research for completeness and adherence with IRB policy, institutional requirements and state/federal regulations. The IRB Analyst assists with communication of educational directives and outreach to the research community. The IRB Analyst serves as the frontline of communication between the IRB and researchers by providing excellent researcher support.

Requirements

Bachelor’s degree in a relevant field.
At least 1 years’ knowledge and experience in research.
Ability to analyze and communicate complex issues effectively and professionally within all levels of the institution (university administrators, faculty members, students, and other research personnel).
Ability to maintain confidentiality of sensitive information.
Demonstrated knowledge of research design and methodology.
Effective planning and organizational skills.
Ability to set priorities, meet deadlines and manage multiple projects.
Demonstrated ability in presenting written and verbal information, ideas, and concepts in a clear, concise, and professional manner.
Ability to function independently, including the ability to determine when decisions can be appropriately made and when they must be referred to higher levels for consideration.
Relevant education and experience may be substituted as appropriate.

Nice To Haves

Master’s degree in relevant field.
2+ years’ experience in research compliance or research administration in an academic or clinical setting.
Experience in reviewing and applying federal rules and regulations to human subjects research.
Certification/licensure such as Certified IRB Professional (CIP), Certified Clinical Research Associate (CCRA), etc

Responsibilities

IRB Submission Analysis and Review (Committee & Non-Committee Review) Analyze research applications, utilizing independent judgment, to conduct in-depth review to ensure IRB submissions are adequately prepared and meet all regulatory criteria for approval or exemption from federal regulations. Identify regulatory, policy and ethics issues requiring correction prior to approval. Correspond with investigators, coordinators, and/or other appropriate study personnel to resolve identified issues. Work collaboratively with colleagues, ancillary reviewers, and researchers to ensure all reviews are completed accurately and in a timely manner. Identify and promptly communicate any issues with research review process, study documentation and determinations, to leadership to maintain high quality and accurate records. Maintain working knowledge of current federal and state regulations, guidelines and trends influencing the conduct of human subjects research and research/medical ethics and applies knowledge to IRB reviews. Maintain current knowledge of UT IRB policies and procedures and any updates or additions that may be made. Committee Review Team: Provide consultation to IRB members regarding meeting conduct requirements, institutional policies and procedures, and state/federal regulations. Work collaboratively with IRB member(s) to review submissions in a timely manner and provide feedback to researchers within established timelines. Attend and participate in monthly convened IRB meetings. Complete post-meeting activities to ensure discussion and determinations are appropriately documented.
Supports the HRPP and Serves as a Resource for Research Community Provide consultation and education to investigators and research staff regarding regulatory requirements and IRB written policies and procedures. Provide support to the research community through IRB Chat, Virtual Office Hours, and other initiatives, as needed. Works collaboratively with colleagues to create and revise standard operating procedures and guidance documents pertinent to the IRB review process and full board operations under the guidance of IRB leadership, as appropriate. Engage with leadership in identifying areas of improvement and assist in developing solutions and implementation of changes. Identify and promptly communicate any issues with internal or external facing resources to leadership to maintain high quality and accurate information for our department and larger research community. Attend and contribute to ORSC, IRB and team specific meetings and trainings to ensure thorough knowledge of changes, updates and initiatives. Assists in the training and the continuing education of colleagues and new employees. Participate in departmental and external educational activities contributing to professional development. Performs other job-related duties as needed and/or assigned.