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.

Duties

This is a bargaining unit position. Areas of Consideration for all Other Positions: 1st - Facility-wide (including satellites) 2nd - Administration or Staff office posting the vacancy. 3rd - All other Status eligibles. VA offers a comprehensive total rewards package: VA Total Rewards Work Schedule: Monday - Friday, 8am - 430pm Telework: Available - Based on agency policy Duty Location Status: Will work from a VA owned or leased space Position Description Title/PD#: Program Specialist - Medical Research IRB Coordinator/ PD91480-A Financial Disclosure Report: Not Required Physical Demands: The work is primarily sedentary, although some slight physical effort may be required. Major Duties: 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

Requirements

• You must be a U.S. citizen to apply for this job.
• Selectees are subject to a background/suitability investigation.
• Selectees may be required to serve a probationary period.
• Selective Service Registration is required for males born after 12/31/1959.
• A complete application package, i.e., Resume, Transcripts, etc., as required by job announcement.
• Selected applicants will be required to complete an online onboarding process.
• Participation in the Seasonal Influenza Prevention Program for VHA Health Care Personnel (HCP) is a requirement for all Department of Veterans Affairs HCP.
• 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.
• Must be proficient in written and spoken English.
• Pre-employment physical examination/evaluation may be required.
• 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

To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 06/20/2024. Time-In-Grade Requirement: Applicants who are current Federal employees and have held a GS grade any time in the past 52 weeks must also meet time-in-grade requirements by the closing date of this announcement. For a GS-09 position you must have served 52 weeks at the GS-07. The grade may have been in any occupation, but must have been held in the Federal service. An SF-50 that shows your time-in-grade eligibility must be submitted with your application materials. Provide a copy of your last or most recent SF-50, "Notification of Personnel Action" to indicate your current federal status. You must also submit additional SF-50(s) to clearly demonstrate one year time-in-grade as required in the announcement. If the most recent SF-50 has an effective within the past year, it may not clearly demonstrate that you possess one year time-in-grade. In this instance, you must provide an additional SF-50 that clearly demonstrates one year time-in-grade. Time-In-Grade requirements also apply to former Federal employees applying for reinstatement as well as current employees applying for Veterans Employment Opportunities Act of 1998 (VEOA) appointment. AND Selective Placement Factor: This position includes a 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 it are ineligible for further consideration. Evidence of the Selective Placement Factor must be reflected in your resume. 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. AND You may qualify based on your education/experience/combination as described below. A transcript must be submitted with your application if you are basing all or part of your qualifications on education. Specialized Experience: You must have one year of specialized experience equivalent to at least the next lower grade in the normal line of progression for the occupation in the organization. Specialized experience is defined as 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: Applicants may substitute education for the required experience. To qualify based on education for this grade level you must have 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: Applicants may also combine education and experience to qualify at this level. You must have an combination of specialized experience and education at the graduate level in order to qualify. 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 for this position: Attention to Detail Communication Compliance Selective Placement Factor Technical Competence Per Office of Personnel Management General Schedule Qualification Policies, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable when documented by satisfactory evidence (e.g., a memorandum from the manager, human resources director, or official documentation such as SF-52, SF-50 documenting an official detail/assignments, or other comparable documentation). The documentation must indicate whether the employee performed the duties full time or, if part-time, the percentage of times the employee performed the additional duties. To receive credit for experience in your resume that is not within the official series and grade level of your position, you must provide official documentation of such experience as indicated above. 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; religions; 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. Note: A full year of work is considered to be 35-40 hours of work per week. 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. For more information on these qualification standards, please visit OPM's web site at http://www.opm.gov/qualifications/standards/indexes/alph-ndx.asp.

Education

PLEASE NOTE: Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications (particularly positions with a positive education requirement). Therefore, applicants must report only attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education. Applicants can verify accreditation at the following website: http://www.ed.gov/admins/finaid/accred/index.html. All education claimed by applicants will be verified by the appointing agency accordingly. 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.

Contacts

• Address Cleveland ORD VISN 10 Federal Building, 1240 East 9th St Cleveland, OH 44199 US
• Name: VHA National Recruitment Center
• Phone: (844)456-5208
• Email: [email protected]