Summary Employee will be assigned to Medical Research Service, VA Greater Los Angeles Health Care System, Los Angeles, CA, serving as a Health System Specialist focusing on Human Subjects Protections (HRPP)/Institutional Review Board (IRB). The employee will provide administrative and technical support and serve as a point of contact for all research affecting humans. Responsibilities ***THIS IS NOT A VIRTUAL POSITION, YOU MUST LIVE WITHIN OR BE WILLING TO RELOCATE WITHIN A COMMUTABLE DISTANCE OF THE DUTY LOCATION*** IRB Committee Management and Applications Oversight Receives all submissions to the Institutional Review Board (IRB), reviews the submissions for appropriateness of referral for IRB review and completeness of submission, and submits them to the appropriate Committee. Contacts the investigator to request additions or corrections to bring the submission to the most complete level possible before submission to the IRB: this often involves educating investigators on the regulations and helping them modify their proposed study to comply. Reviews all incoming Adverse Event Reports for completeness and urgency, and independently obtains additional information, if necessary, from the investigator. Administers screening, advisory and approval processes for the organization's health sciences research program. Monitors contract and budget data. Verifies that reports required by facility research procedures are complete and submitted within required timeframes. Performs a variety of administrative duties to maintain specialized data and implement study design. Policies & Procedure Development, Implementation and Communication Develops policies, procedures, and criteria for administration of the organization's health science research program for Human Research Protection Program (HRPP) based on national guidelines and facility needs. Develops local procedures which implement agency policies on basic and applied research program development, administration and consults with facility scientists to resolve issues and to tailor broad guidelines to the facilities research program needs. Assists investigators in preparation of reports and in implementation of procedures within individual laboratories or for specific projects. Monitors and reviews all IRB processes to ensure full compliance. Documentation, Reporting and Project Tracking Establishes study files containing all materials submitted, all reviewer comments, all official approval documents, and all related VHA facility documents. Keeps a project-tracking database up to date. Conducts program assessments and prepares reports necessary to program continuity and reporting. Proposal Review & Audits Provides consultation and assistance to research investigators in designing and preparing research proposals for internal and external review. Interprets a variety of complex federal regulations, organizational policy and good clinical practice requirements. Develops and implements an electronic submission and approval process. Performs special and ad-hoc reviews or assessments for the IRB/HRPP program, as needed and required. Performs other related duties as assigned. Work Schedule: Monday - Friday, 8:00am - 4:30pm. Recruitment & Relocation Incentives: Not authorized Telework: VA supports the use of telework as a way to help attract and retain talented individuals in public service, increase worker productivity, and better prepare the agency to operate during emergencies. This position may be authorized for ad-hoc telework. Telework eligibility will be discussed during the interview process. Requirements Conditions of Employment You must be a U.S. Citizen to apply for this job Selective Service Registration is required for males born after 12/31/1959 You may be required to serve a probationary period Subject to background/security investigation Selected applicants will be required to complete an online onboarding process Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP) Participation in the Coronavirus Disease 2019 (COVID-19) vaccination program is a requirement for all Veterans Health Administration Health Care Personnel (HCP) - See "Additional Information" below for details. Qualifications SPECIALIZED EXPERIENCE: Applicants must possess one (1) year of specialized experience that equipped them with the particular knowledge, skill, and abilities to perform successfully the duties of this position, and that is typically in or related to the work of this position. To be creditable, this experience must have been equivalent to at least the GS-11 level in the Federal service. Specialized experience is progressively responsible analytical or administrative, or clinical management or supervisory experience in the health care field. This work may have been performed in an operating health care facility or a higher organizational echelon with advisory or directional authority over such facilities. Work must have involved a close working relationship with facility managers and analysis and/or coordination of administrative, clinical, or other service activities, and provided knowledge of the following: (a) Missions, organizations, programs, and requirements of health care delivery systems; (b) Regulations and standards of various regulatory and credentialing groups; (c) Government-wide, agency, and facility systems and requirements in various administrative areas such as budget, personnel and procurement. This also includes experience working with program goals and objectives, work processes, and administrative operations of Institutional Review Board (IRB) processes. You will be rated on the following Competencies as part of the assessment questionnaire for this position: Administration and Management Compliance Critical Thinking Manages and Organizes Information Technical Documentation IMPORTANT: A full year of work is considered to be 35-40 hours of work per week. All experience listed on your resume must include the month and year start/end dates. Part-time experience will be credited on the basis of time actually spent in appropriate activities. Applicants wishing to receive credit for such experience must indicate clearly the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience. Physical Requirements: The work is sedentary. Typically, the employee may sit comfortably to perform portions of the work. However, there is periodic walking; standing; bending; carrying of light items such as medical records, food trays, instructional material, books, and manuals. The employee should be able to lift 10 pounds. 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 There is no educational substitution at this grade level. Additional Information This job opportunity announcement may be used to fill additional vacancies. Pursuant to VHA Directive 1193.01, VHA health care personnel (HCP) are required to be fully vaccinated against COVID-19 subject to such accommodations as required by law (i.e., medical, religious or pregnancy). VHA HCPs do not include remote workers who only infrequently enter VHA locations. If selected, you will be required to be fully vaccinated against COVID-19 and submit documentation of proof of vaccination before your start date. The agency will provide additional information regarding what information or documentation will be needed and how you can request a legally required accommodation from this requirement using the reasonable accommodation process. If you are unable to apply online or need an alternate method to submit documents, please reach out to the Agency Contact listed in this Job Opportunity Announcement. 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.