Summary This position is in the office of the Associate Chief of Staff for Research & Development, which provides a variety of support for active Research Investigators, VA personnel and non-VA personnel. The employee is a key member of the staff. The employee will act as Protocol Analyst for the VA Tennessee Valley Healthcare System (TVHS) IRD. S/he will provide technical and interpretive procedural and administrative support and management for the Institutional Review Board (IRD). Responsibilities This is a bargaining unit position. VA offers a comprehensive total rewards package: VA Total Rewards Work Schedule: Monday - Friday 8am - 4:30 pm Compressed/Flexible Schedule: Not Available Telework: Available Duty Location Status: Will work from a VA owned or leased space Position Description Title/PD#: Program Analyst/ PD70304A Relocation/Recruitment Incentives: Not Authorized Permanent Change of Station (PCS): Not Authorized Financial Disclosure Report: Not Required Physical Demands: The work is primarily sedentary, although some slight physical effort may be required Major Duties: Creates step-by-step guidance, local processing instructions, and templates for Principal Investigators (PI) and other key project personnel who submit applications for review by the IRB. Provides additional face-to-face education/training for PI's and staff for project submissions and system procedures. Incumbent exercises independent authority to advise, inform and instruct investigators and/or research team personnel to insure required federal, state, and local laws and regulations are addressed appropriately in the research application. Incumbent conducts in-depth review and creates reports that summarize the results of her/her administrative review. Provides in-depth scrutiny of complex documentation provided by the research investigators requesting review and approval by the (IRB). Reviews a broad spectrum of documents, such as conflict of interest declarations, drafted consent form templates, HIPPA authorization templates, information security management plans for complex research studies/project for completeness, accuracy and ensures compliance with local and federal policies and regulations. Incumbent assigns primary and secondary reviewer(s) correlating the scientific methodology associated with the research project and the clinical and/or scientific expertise of the committee members ensuring the protection of human research participants and to ensure that risk of harm to participants is minimized. Analyzes application packages to determine the appropriate type of review by the board. Analyzing completed submission and forwarding to appropriate committees based on type of submission requirements. Maintains and prepare electronic records of the IRB recommendations and final decisions regarding VA research. Incumbent prepares and submits ongoing and new studies to Research and Development Committee. Regularly attends IRB meetings to present and clarify protocol implementation. The employee maintains up-to-date knowledge of federal regulations regarding research involving human subjects. Process, review, prioritize and forward "Adverse Event" submissions as submitted to ensure timely notification to appropriate reviewers and management, in accordance with applicable federal and VA regulations regarding patient safety. Conducts quality assurance reviews as directed. Requirements Conditions of Employment Qualifications To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 10/03/2024. 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 You may qualify based on your education/experience 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 GS-07 in the normal line of progression for the occupation in the organization. Specialized experience is defined as: Creating step-by-step guidelines, local processing instructions and templates, Exercise independent authority to advise, inform, and instruct investigators and/or research team personnel, conducts in-depth review and create reports, & Reviews a broad spectrum of documents. Education: Applicants may substitute education for the required experience. To qualify based on education for this grade level you must have a 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; OR Combination: Applicants may also combine education and experience to qualify at the GS-09 level. To calculate, first identify the percentage of required education you have earned (when substituting, you cannot use the first 60 semester hours that you earned). Then identify the percentage of required experience you possess. Add the two percentages. The total percentage must equal at least 100 percent to qualify at the GS-09. For example, an applicant who has 9 semester hours of graduate level education (i.e. 50% of graduate education required) and 6 months of creditable specialized experience (i.e. 50% of the required experience) would equal 100% of the required experience for the position. A transcript must be submitted with your application if you are basing all or part of your qualifications on education. 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. Additional Information The Interagency Career Transition Assistance Plan (ICTAP) and Career Transition Assistance Plan (CTAP) provide eligible displaced VA competitive service employees with selection priority over other candidates for competitive service vacancies. To be well-qualified, applicants must possess experience that exceeds the minimum qualifications of the position including all selective factors if applicable, and must be proficient in most of the requirements of the job. Information about ICTAP and CTAP eligibility is on OPM's Career Transition Resources website which can be found at https://www.opm.gov/. This job opportunity announcement may be used to fill additional vacancies. The Fair Chance to Compete for Jobs Act (or the Act) prohibits the Department of Veterans Affairs (VA) from requesting applicant criminal history record information before extending a conditional or tentative offer of employment. In accordance with 5 U.S.C § 9202(c) and 5 C.F.R § 920.201 certain positions are exempt from the provisions of the Act. Applicants who believe they have been subjected to a violation of the Act, may submit a written complaint within 30 calendar days of the date of the alleged non-compliance to VA at vacofairchanceact@va.gov. Applicant written complaints should include the following: Administration name: Veterans Health Administration (VHA) Office name, employee name and contact information or contractor who made contact (if known). Date of contact. Details regarding the job opportunity announcement applied to, and copies of any documents or other evidence related to the complaint. Visit Office of the Chief Human Capital Officer (OCHCO) for more information. 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.