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Summary Located within the office of Reach and Development, this Program Specialist serves at the Institutional Review Board (IRB) Coordinator for the VA Northeast Ohio Healthcare System's (VANEOHS) Medical Research Program. The person in this position is responsible for reviewing and approving all human subjects research at VANEOHS and is the first resource for information regarding IRB regulations and guidance. Responsibilities THIS IS NOT A VIRTUAL POSITION, YOU MUST LIVE WITHIN OR BE WILLING TO RELOCATE WITHIN A COMMUTABLE DISTANCE OF THE DUTY LOCATION Major duties and responsibilities include: Advises, informs, and instructs research investigators and research team personnel on federal regulations applicable to research involving human subjects Serves as an expert resource regarding complex federal regulations and guidance regarding the conduct and approval of human studies research Applies knowledge of a variety of clinical research areas such as infectious disease, oncology, and oncology, in order to understand and analyze proposed research Performs in-depth and detailed analysis of a wide variety of complicated and diverse submissions to the IRB, including new, modified, and updated projects; continuing reviews; serious and unanticipated adverse events; findings non-compliance; and protocol deviations Arranges meetings to gain a better understanding of research protocol, explain and cite regulations, and advise on submission improvements Acts as a liaison between review board members and or researchers Performs analytical and evaluative work associated with IRB activities Prepares reports regarding IRB performance and metrics Makes recommendations for quality improvement activities based on report findings Prepares IRB minutes, documenting specific regulatory requirements met for each item reviewed Prepared and provides education to investigators and research staff involved in human subjects research Performs other related duties, as assigned Work Schedule: Monday through Friday, 8:00am to 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 telework. Telework eligibility will be discussed during the interview process. Financial Disclosure Report: Not Required 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 This position includes a Selective Placement Factor (skill, knowledge, ability or other worker characteristic basic to - and essential for - satisfactory performance of the job). Selective Placement Factors are a prerequisite to appointment and represent minimum requirements for a position. Applicants who do not meet them are ineligible for further consideration. The Selective Placement Factor for this position is: Experience managing and reviewing documents and protocols that are submitted to a Research Institutional Review Boards (IRB) to ensure adherence to federal regulations. In addition to the Selective Placement Factor, you must meet one of the following: Specialized Experience: At least one (1) full year of specialized experience equivalent to at least the next lower grade level (GS-7) in the Federal Service that has given you the particular knowledge, skills and abilities required to successfully perform the duties of a Program Specialist - Medical Research IRB Coordinator. Specialized experience includes: Experience applying knowledge of policies, procedures and practices as they relate to research and human subjects research; Analyzing and interpreting government regulations, accreditation standards, agency policies and other guidance documents; Reviewing and assessing compliance of research proposals against regulations, policies and guidelines governing human subjects research; Communicating both verbally and in writing with individuals with diverse backgrounds. NOTE: Applicants wishing to receive credit for such experience must clearly indicate the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment. OR Education: Successful completion of a master's or equivalent graduate degree or two (2) full years of progressively higher-level graduate education leading to such a degree that demonstrates the knowledge, skills, and abilities necessary to do the work of this Program Specialist - Medical Research IRB Coordinator. NOTE: If you select this option, you must submit a copy of your transcript (unofficial or official) with your application. Education cannot be credited without documentation. OR Combination: Equivalent combinations of successfully completed graduate-level education (beyond the first year) and specialized experience, as described above, which meet the total experience requirements for this grade level. NOTE: If you select this option, you must submit a copy of your transcript (unofficial or official) with your application. Education cannot be credited without documentation. You will be rated on the following Competencies as part of the assessment questionnaire for this position: Attention to Detail Communication Compliance Selective Placement Factor Technical Competence 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 primarily sedentary, although some slight physical effort may be required. 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: Recognition of Foreign Qualifications | International Affairs Office (ed.gov). Additional Information 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. Special Employment Consideration: VA encourages persons with disabilities to apply, including those eligible for hiring under 5 CFR 213.3102(u), Schedule A, Appointment of persons with disabilities (i.e., intellectual disabilities, severe physical disabilities, or psychiatric disabilities), and/or disabled veterans with a compensable service-connected disability of 30% or more. For more information on how to apply using this appointment authority via the Selective Placement Coordinator within the office, contact the facility Human Resources Department at (202) 020-2020. 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 85 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/. 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.