Program Specialist

Summary This position is located in the Office of Research and Development at VA Salt Lake City Healthcare System - George E Wahlen VA Medical Center in Salt Lake City, UT. The Program Specialist serves as an Institutional Review Board (IRB) Liaison and is responsible for providing support for VA Research Investigators, VA personnel and non-VA personnel on matters pertaining to human studies, IRB submissions, and documentation. Learn more about this agency Duties ***THIS IS NOT A VIRTUAL POSITION, YOU MUST LIVE WITHIN OR BE WILLING TO RELOCATE WITHIN A COMMUTABLE DISTANCE OF THE DUTY LOCATION*** This position involves a multi-grade career ladder. The major duties listed below represent the full performance level of GS-11. At the GS-09 grade level, you will perform assignments of a more limited scope and with less independence. You will progressively acquire the background necessary to perform at the full performance level of GS-11. Promotion is at the discretion of the supervisor and is contingent upon satisfactory performance, availability of higher-level work, and availability of funds. The Program Specialist - IRB liaison provides procedural and administrative support and management of IRB matters to VHA PIs and liaison with the Affiliate (University of Utah) Institutional Review Board (IRB), Central IRB (CIRB) and the National Cancer IRB (NCIRB), as well as any other IRBs, which review research projects involving human subjects conducted by VA personnel or by non-VA personnel at the SLCVAMC. Major duties and responsibilities include but not limited to: IRB Training Serving as the primary contact for VHA Principal Investigators (PIs) and research staff regarding IRB guidance and training Advising and instructing investigators and research personnel on proper IRB submission protocols in compliance with VHA and federal regulations Creating, reviewing, editing, and retiring VHASLC Standard Operating Procedures (SOPs) related to IRB operations Maintaining databases of guides, manuals, references, and desk resources for R&D staff and investigators Maintaining current knowledge of federal, VA, and IRB regulations involving human subject research Maintaining communication with OHRP and FDA coordinators while reviewing trade journals and professional literature regularly IRB Review Pre-reviewing new and renewal IRB submissions for accuracy, completeness, and compliance with applicable regulations and policies Independently evaluating IRB submissions and identifying deficiencies requiring correction Communicating required revisions to investigators and reviewing resubmitted materials before forwarding to the appropriate IRB Creating and maintaining databases to track annual continuing reviews for human studies Reviewing and analyzing annual review submissions for compliance with VHA requirements and updated policies/regulations Discussing corrective actions with PIs and research staff when deficiencies are identified IRB Liaison Communicating updates to VHA, ORO, and OHRP regulations and laws to the IRB of record Ensuring IRB procedures are updated to maintain regulatory compliance Ensuring all IRB applications are processed accurately and efficiently Attending IRB meetings and reporting updates to R&D Leadership and the Research and Development Committee Reviewing IRB meeting minutes for accuracy and ensuring inclusion in the R&D Committee's monthly agenda Record Keeping Reviewing study applications to verify personnel have appropriate scope of practice, licenses, credentials, and privileges Maintaining and updating required documentation related to study personnel qualifications Ensuring ePROMISe entries remain current and accurate Work Schedule: Monday to Friday; 08:00 a.m. to 04:30 p.m. Recruitment & Relocation Incentives: Not authorized Critical Skills Incentive (CSI): Not Approved Telework: Ad-Hoc only Requirements Conditions of employment You must be a U.S. Citizen to apply for this job To be considered for this position, you must complete all required steps in the process. In addition to the application and questionnaire, this position requires an online assessment. The online assessment measures critical general competencies required to perform the job. All applicants tentatively selected for VA employment in a testing designated position are subject to urinalysis to screen for illegal drug use prior to appointment. Applicants who refuse to be tested will be denied employment with VA. Selective Service Registration is required for males born after 12/31/1959 Physical Requirements: The work is sedentary. Typically, the employee sits at a desk or table with some walking and standing. Incumbent may be required to travel to other VA and non-VA locations in the community. Subject to background/security investigation Selected applicants will be required to complete an online onboarding process. Acceptable form(s) of identification will be required to complete pre-employment requirements (https://www.uscis.gov/i-9-central/form-i-9-acceptable-documents). Effective May 7, 2025, driver's licenses or state-issued identification cards that are not REAL ID compliant cannot be utilized as an acceptable form of identification for employment. Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP) - See "Required Documents" below for details. As a condition of employment for accepting this position, you will be required to serve a 1-year probationary period during which we will evaluate your fitness and whether your continued employment advances the public interest. In determining if your employment advances the public interest, we may consider: your performance and conduct; the needs and interests of the agency; whether your continued employment would advance organizational goals of the agency or the Government; and whether your continued employment would advance the efficiency of the Federal service. Upon completion of your probationary, your employment will be terminated unless you receive certification, in writing, that your continued employment advances the public interest. Qualifications Minimum Requirement: The following are minimum requirements for appointment as a Program Specialist in the Veterans Health Administration (VHA), which all applicants must met. Specialized Experience (GS-09): You must have one (1) year of specialized experience that equipped you with the particular knowledge, skills, and abilities (KSA's) to perform successfully the duties of the position, and that is typically in or related to the position to be filled. To be creditable, specialized experience must have been equivalent to at least the next lower grade level (i.e., GS-07) in the normal line of progression for the occupation in the organization. Qualifying examples of specialized experience would typically include but not limited to: interpreting and applying federal regulations, state laws, and agency policies related to human subjects research; reviewing research submissions for accuracy, completeness, and regulatory compliance; communicating regulatory interpretations, procedural requirements, and corrective actions to stakeholders; and analyzing research protocols for compliance and human subject protection issues. (CLEAR DETAILS OF EXPERIENCE REQUIRED: Your resume must show complete information for each job entry, such as beginning and ending dates of employment, duties performed, and/or total hours worked per week.) OR, Education (GS-09): Applicants may substitute education for the required experience. To qualify based on education for this grade level you must have master's or equivalent graduate degree or 2 full years of progressively higher level graduate education leading to such a degree or LL.B. or J.D., if related. Such education must demonstrate the knowledge, skills, and abilities necessary to do the work. NOTE: One year of full-time graduate education is considered to be the number of credit hours that the school attended has determined to represent 1 year of full-time study. If that information cannot be obtained from the school, 18 semester hours should be considered as satisfying the 1 year of full-time study requirement. Part-time graduate education is creditable in accordance with its relationship to a year of full-time study at the school attended. (UNOFFICIAL TRANSCRIPT REQUIRED: If you do not submit your transcript, your application may not be reviewed.) OR, Combination (GS-09): Applicants may also combine education and experience to qualify at this level. You must have a combination of specialized experience and education as described above. Only graduate education in excess of the amount required for the next lower grade level (i.e., 18 semester hours) may be used to qualify applicants for positions at grades GS-09. (UNOFFICIAL TRANSCRIPT REQUIRED: If you do not submit your transcript, your application may not be reviewed.) Specialized Experience (GS-11): You must have one (1) year of specialized experience that equipped you with the particular knowledge, skills, and abilities (KSA's) to perform successfully the duties of the position, and that is typically in or related to the position to be filled. To be creditable, specialized experience must have been equivalent to at least the next lower grade level (i.e., GS-09) in the normal line of progression for the occupation in the organization. Qualifying examples of specialized experience would typically include but not limited to: interpreting and applying federal regulations, state laws, and agency policies related to human subjects research; reviewing research submissions for accuracy, completeness, and regulatory compliance; communicating regulatory interpretations, procedural requirements, and corrective actions to stakeholders; analyzing research protocols for compliance and human subject protection issues; coordinating IRB review processes, including expedited, exempt, and full board reviews; preparing correspondence, reports, and regulatory determinations related to IRB actions and human subjects protections activities; and providing guidance and technical assistance to investigators, research staff, and IRB members regarding regulatory and policy requirements. (CLEAR DETAILS OF EXPERIENCE REQUIRED: Your resume must show complete information for each job entry, such as beginning and ending dates of employment, duties performed, and/or total hours worked per week.) OR, Education (GS-11): Applicants may substitute education for the required experience. To qualify based on education for this grade level you must have Ph.D. or equivalent doctoral degree or 3 full years of progressively higher level graduate education leading to such a degree or LL.M., if related. Such education must demonstrate the knowledge, skills, and abilities necessary to do the work. NOTE: One year of full-time graduate education is considered to be the number of credit hours that the school attended has determined to represent 1 year of full-time study. If that information cannot be obtained from the school, 18 semester hours should be considered as satisfying the 1 year of full-time study requirement. Part-time graduate education is creditable in accordance with its relationship to a year of full-time study at the school attended. (UNOFFICIAL TRANSCRIPT REQUIRED: If you do not submit your transcript, your application may not be reviewed.) OR, Combination (GS-11): Applicants may also combine education and experience to qualify at this level. You must have a combination of specialized experience and education as described above. Only graduate education in excess of the amount required for the next lower grade level (i.e., 36 semester hours) may be used to qualify applicants for positions at grades GS-11. (UNOFFICIAL TRANSCRIPT REQUIRED: If you do not submit your transcript, your application may not be reviewed.) For more information on these qualification standards, please visit the United States Office of Personnel Management's website at https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/. Education IMPORTANT: A transcript must be submitted with your application if you are basing all or part of your qualifications on education. NOTE: Only education or degrees recognized by the U.S. Department of Education from accredited colleges, universities, schools, or institutions may be used to qualify for Federal employment. You can verify your education here: http://ope.ed.gov/accreditation/. If you are using foreign education to meet qualification requirements, you must send a Certificate of Foreign Equivalency with your transcript in order to receive credit for that education. For further information, visit: https://sites.ed.gov/international/recognition-of-foreign-qualifications/. Additional information Reasonable Accommodation (RA) Requests: If you believe you have a disability (i.e., physical or mental), covered by the Rehabilitation Act of 1973 as amended that would interfere with completing the USA Hire Competency Based Assessments, you will be granted the opportunity to request a RA in your online application. Requests for RA for the USA Hire Competency Based Assessments and appropriate supporting documentation for RA must be received prior to starting the USA Hire Competency Based Assessments. Decisions on requests for RA are made on a case-by-case basis. If you meet the minimum qualifications of the position, after notification of the adjudication of your request, you will receive an email invitation to complete the USA Hire Competency Based Assessments, based on your adjudication decision. You must complete all assessments within 48 hours of receiving the URL to access the USA Hire Competency Based Assessments if you received the link after the close of the announcement. To determine if you need a RA, please review the Procedures for Requesting a Reasonable Accommodation for Online Assessments. Receiving Service Credit for Earning Annual (Vacation) Leave: Federal Employees earn annual leave at a rate (4, 6 or 8 hours per pay period) which is based on the number of years they have served as a Federal employee. Selected applicants may qualify for credit toward annual leave accrual, based on prior work experience or military service experience. This credited service can be used in determining the rate at which they earn annual leave. Such credit must be requested and approved prior to the appointment date and is not guaranteed. This job opportunity announcement may be used to fill additional vacancies. Under the Fair Chance to Compete Act, the Department of Veterans Affairs prohibits requesting an applicant's criminal history prior to accepting a tentative job offer. For more information about the Act and the complaint process, visit Human Resources and Administration/Operations, Security, and Preparedness (HRA/OSP) at The Fair Chance Act. The Interagency Career Transition Assistance Plan (ICTAP) and Career Transition Assistance Plan (CTAP) provide eligible displaced Federal competitive service employees with selection priority over other candidates for competitive service vacancies. To be qualified you must submit appropriate documentation and be found well-qualified (have a final rating of 80 or more before any Veterans preference points) for this vacancy. Information about ICTAP and CTAP eligibility is on OPM's Career Transition Resources website at http://www.opm.gov/policy-data-oversight/workforce-restructuring/employee-guide-to-career-transition/. Expand Hide  additional information Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution. Benefits A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits. Review our benefits Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.