Job Posting Title:
IRB Analyst or Senior IRB Analyst, Office of Research Support and Compliance----
Hiring Department:
Office of Research Support and Compliance----
Position Open To:
All Applicants----
Weekly Scheduled Hours:
40----
FLSA Status:
To Be Determined at Offer----
Earliest Start Date:
Ongoing----
Position Duration:
Expected to Continue----
Location:
AUSTIN, TX----
Job Details:
General Notes
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
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. 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. Assists with communication of educational directives and outreach to the research community. Serves as the frontline of communication between the IRB and researchers by providing excellent researcher support.
Responsibilities
IRB Analyst:
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.
Senior IRB Analyst:
IRB Submission Analysis and Review (Committee & Non-Committee Review)
Serve as a member of the UT Institutional Review Board (IRB). Serves as a designated reviewer with the authority to make independent regulatory determinations, provide exempt determinations, approve expedited research, and approve changes to full board research that are eligible for expedited review. Serves as Privacy Board member.
Independently review biomedical and behavioral research proposals submitted to the IRB in compliance with Federal, state, local regulations/laws and Institutional policies and procedures. Identifies issues or concerns that must be addressed in order to approve the research and communicates issues to researchers in a professional and educational manner.
Ensure accurate and timely processing, tracking, and review of submissions and documentation of IRB determinations.
Guide investigators through the application submission process. Independently advises investigators on applicable policies, procedures, guidelines, federal regulations, and other compliance related requirements.
Review requests to amend or modify approved protocols and make determination about which requests require full IRB review and which can be reviewed using an expedited process (committee review team).
Manage the intake and review process of reportable new information for assigned protocols, which may include unanticipated problems, non-compliance or allegations of non-compliance with federal, state, or institutional regulation, policy, or guidance, and safety reports. Present reportable information to IRB Chair and committee members, as required.
Ensure timely processing, review and disposition of research applications within established expectations and SOPs.
Work collaboratively with leadership and the electronic submission team to resolve problems, suggest improvements and test programming upgrades.
Committee review team:
Provide expert support to IRB members regarding meeting conduct requirements, institutional policies and procedures, and state/federal regulations and function as a liaison within and between the IRB committee, investigators, and other staff.
Assist committee manager with preparing meeting agendas and assignment of reviewers for each panel meeting based on knowledge of scientific aspects of the research submissions to be reviewed, as well as regulatory requirements and the expertise/role of each panel member.
Participate in administrative functions of IRB meetings, including ensuring quorum, providing regulatory guidance at the meeting and ensuring meeting minutes are complete, accurate, and provided to members per established SOPs.
Participate in training new IRB committee members and ongoing education of current committee members.
Actively participate in monthly convened IRB meetings. Act as an alternate voting member when needed.
Supports the HRPP and Serves as a Resource for Research Community
Serve as subject matter expert in state, local, and federal laws and regulations as they apply to human subjects. Demonstrate a clear, high-level knowledge of institutional policies and procedures and best practices related to human subjects protection.
Serve as a point of contact for questions and concerns from IRB Analysts, IRB members, research teams, and other stakeholders.
Participate in various customer service activities including IRB Chat, Virtual Office Hours, and other initiatives, as needed.
Participate in the development and implementation of standard operating procedures (SOPs) and other guidance documents pertinent to the IRB review process and committee/non-committee IRB operations.
Work collaboratively with leadership and the electronic submission team to resolve problems, suggest improvements and test programming upgrades.
Maintain working knowledge of best practices and trends within the human research protection field.
Volunteer for and perform other job-related duties as needed and/or assigned.
Provide Mentorship/Guidance to IRB Analyst Staff
Provide guidance and mentorship regarding regulatory, policy, or process questions and assist with workflow and workload issues.
Provide feedback to IRB Analysts regarding their pre-reviews of IRB submissions to ensure regulatory compliance and facilitate better understanding.
Assist in training new IRB Analysts and provide on-going guidance regarding application of federal, state, and institutional regulations, guidance, and policies to human subjects research.
Creates educational presentations, materials, and guidance to aide in IRB staff understanding of relevant topics.
Foster a collaborative team environment and keep management apprised of issues/needs of the staff.
Required Qualifications
IRB Analyst:
Bachelor’s degree in a relevant field.
At least 3 years experience coordinating or administering a program with 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.
Senior IRB Analyst:
Requires Bachelor’s degree or equivalent in education/experience.
At least 5 years’ experience in research, research administration, or applicable research experience.
At least 2 years of related experience in an IRB or HRPP environment at an academic institution or in a healthcare setting.
Current Certified IRB Professional or demonstration of equivalent competency, as appropriate.
Demonstrated ability to act as an independent reviewer for human research proposals.
Comprehensive knowledge of federal, state, and local regulations, policies, and best practices governing human subjects research including: HHS-OHRP regulations, FDA regulations, and university policy regarding human subjects research.
Relevant education and experience may be substituted as appropriate.
Preferred Qualifications
IRB Analyst:
Master’s degree in relevant field.
3+ years’ experience in research compliance or research administration in an academic or clinical setting.
Certification/licensure such as Certified IRB Professional (CIP), Certified Clinical Research Associate (CCRA), etc.
Experience in reviewing and applying federal rules and regulations to human subjects research.
Senior IRB Analyst:
Master’s degree in a relevant field.
5+ years’ experience in research compliance or research administration in an academic or clinical setting.
Salary Range
IRB Analyst:
$60,000 + depending on qualifications
Senior IRB Analyst:
$70,000 + depending on qualifications
Working Conditions
May work around standard office conditions
Repetitive use of a keyboard at a workstation
Occasional interstate and intrastate travel
Required Materials
Please mark "yes" on the application for required materials. Failure to attach all additional materials listed may affect candidates being considered for the position.
Resume/CV
3 work references with their contact information; at least one reference should be from a supervisor.
Letter of interest
Individuals who interview will be asked to submit a writing sample.
Important for applicants who are NOT current university employees or contingent workers: You will be prompted to submit your resume the first time you apply, then you will be provided an option to upload a new Resume for subsequent applications. Any additional Required Materials (letter of interest, references, etc.) will be uploaded in the Application Questions section; you will be able to multi-select additional files. Before submitting your online job application, ensure that ALL Required Materials have been uploaded. Once your job application has been submitted, you cannot make changes.
Important for Current university employees and contingent workers: As a current university employee or contingent worker, you MUST apply within Workday by searching for Find UT Jobs. If you are a current University employee, log-in to Workday, navigate to your Worker Profile, click the Career link in the left hand navigation menu and then update the sections in your Professional Profile before you apply. This information will be pulled in to your application. The application is one page and you will be prompted to upload your resume. In addition, you must respond to the application questions presented to upload any additional Required Materials (letter of interest, references, etc.) that were noted above.
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Employment Eligibility:
Regular staff who have been employed in their current position for the last six continuous months are eligible for openings being recruited for through University-Wide or Open Recruiting, to include both promotional opportunities and lateral transfers. Staff who are promotion/transfer eligible may apply for positions without supervisor approval.----
Retirement Plan Eligibility:
The retirement plan for this position is Teacher Retirement System of Texas (TRS), subject to the position being at least 20 hours per week and at least 135 days in length.----
Background Checks:
A criminal history background check will be required for finalist(s) under consideration for this position.
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Equal Opportunity Employer:
The University of Texas at Austin, as an equal opportunity/affirmative action employer, complies with all applicable federal and state laws regarding nondiscrimination and affirmative action. The University is committed to a policy of equal opportunity for all persons and does not discriminate on the basis of race, color, national origin, age, marital status, sex, sexual orientation, gender identity, gender expression, disability, religion, or veteran status in employment, educational programs and activities, and admissions.
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Pay Transparency:
The University of Texas at Austin will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
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Employment Eligibility Verification:
If hired, you will be required to complete the federal Employment Eligibility Verification I-9 form. You will be required to present acceptable and original documents to prove your identity and authorization to work in the United States. Documents need to be presented no later than the third day of employment. Failure to do so will result in loss of employment at the university.
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E-Verify:
The University of Texas at Austin use E-Verify to check the work authorization of all new hires effective May 2015. The university’s company ID number for purposes of E-Verify is 854197. For more information about E-Verify, please see the following:
E-Verify Poster (English and Spanish) [PDF]Right to Work Poster (English) [PDF]Right to Work Poster (Spanish) [PDF]----
Compliance:
Employees may be required to report violations of law under Title IX and the Jeanne Clery Disclosure of Campus Security Policy and Crime Statistics Act (Clery Act). If this position is identified a Campus Security Authority (Clery Act), you will be notified and provided resources for reporting. Responsible employees under Title IX are defined and outlined in HOP-3031.
The Clery Act requires all prospective employees be notified of the availability of the Annual Security and Fire Safety report. You may access the most recent report here or obtain a copy at University Compliance Services, 1616 Guadalupe Street, UTA 2.206, Austin, Texas 78701.