Summary THE CLOSING DATE OF THIS JOB ANNOUNCEMENT HAS BEEN EXTENDED TO TUESDAY, MARCH 11, 2025. This position serves as Health System Specialist - Research Committee Manager within the Research and Development (R&D) Service. The VA Research Program strives to promote Veteran-centered care to improve patient experiences and outcomes across VA healthcare and community settings, and to advance value-driven care by providing Veterans the highest quality care at the lowest financial burden. Responsibilities Duties and responsibilities include but are not limited to: IRB, Central IRBs, and/or HRPP Program Administration Oversees and manages these programs and their activities, including preparation of committee and reviewer materials with appropriate documentation, ensuring projects are reviewed by appropriate personnel, and ensuring all outstanding issues related to project management are resolved in a timely manner. Serves in an advisory capacity to the R&D Leadership, research investigators, research committee members, and research committee Chairs and others on issues relative to carrying out the institution's research activities involving the use of humans for investigative purposes. Serves as the accreditation Facility Liaison. Oversees the protocol review process of multiple programs and committees, ensuring projects are reviewed by appropriate personnel, including the Information Systems Security Officer (ISSO) and Privacy Officer (PO), and issues related to project management are resolved. Develops and maintains a pre-review program that will coincide with the Minneapolis VA Health Care System IRB and Central IRBs, and/or R&D Committee, review of all research involving human subjects and the human research protection program. Develops and manages required annual and semi-annual reviews of the assigned programs. Stays informed on guidelines relating to security and safety in the conduct of research and advises Research and Safety leadership, as needed. Educates the investigative community of local and external policies and procedures with regards to research involving human subjects. Develops reporting procedures, sampling techniques, and measurements at various points in the research committee process and research programs to identify problem areas or inherent weaknesses in work processes, procedures, information systems and content. Quality and Compliance Responsible for maintaining the federal-wide assurance with the Office of Human Research Protection and ensuring IRBs are appropriately constituted and registered. Analyzes and evaluates each research project to ensure compliance with Federal and State regulations, including but not limited to VA, FDA, OHRP (Office of Human Research Protection), VA Office of Research Oversight (ORO), and other applicable regulatory and procedural requirements. Develops programs, policies, and procedures within the Research Service. Monitors quality assurance program implementation and indicators designed to prevent erroneous transactions and ineffective work practices and to verify adherence to quality assurance plans and requirements. Responsible for alerting investigators of deficiencies found within their submissions and educating them as to the steps required to correct the deficiencies. Administrative Oversight Assumes responsibility in preparing for all external reviews. Researches and/or analyzes problems, administrative issues, or program requirements as they relate to human subjects or research and the research review process. Initiates or reviews correspondence for all research. Oversees and refines customized, networked computerized databases to allow for timely tracking of research projects. Serves as the electronic records system administrator for the Research Office. Promotion Potential: The selectee may be promoted to the full performance level without further competition when all regulatory, qualification, and performance requirements are met. Selection at a lower grade level does not guarantee promotion to the full performance level. Work Schedule: Monday - Friday, 8:00am - 4:30pm Position Description Title/PD#: Health System Specialist - Research Committee Manager/PD99493S and PD99586 Physical Requirements: The work is primarily sedentary, although some slight physical effort may be required. Work is typically performed in an adequately lighted and climate-controlled office. May require occasional travel. Relocation/Recruitment Incentives: Not Authorized Critical Skills Incentive (CSI): Not Approved Permanent Change of Station (PCS): Not Authorized Financial Disclosure: Not Required Requirements Conditions of Employment Qualifications To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 03/11/2025. To qualify for this position at the GS-09 level, you must meet one of the following: Specialized Experience: One year of specialized experience (equivalent to the GS-07 grade level in the federal service); experience that equipped the applicant with the particular knowledge, skills and abilities (KSA's) and other characteristics to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled, in the normal line of progression for the occupation in the organization. Specialized experience includes: perform qualitative and quantitative analytical techniques such as: data analysis, literature search, determining staff to workload ratios, development and administration of questionnaires, graphing, and calculation of means, modes, standard deviations, or similar statistical measures; conduct interviews with supervisors and employees to obtain information about organizational missions, functions, and work procedures; perform a variety of complex tasks related to the approval and maintenance of research projects including regulatory approvals, submissions that are tied to protocol execution, preparation of reports based on a statement of the issue or problem, observations and recommendations for action findings; and possess the ability to use Microsoft Word, Outlook, Excel, PowerPoint, Adobe Pro for word processing, communications, presentations, data manipulation and data storage. OR Education (Transcript Required): To qualify based on education for this grade level you must have a master's or equivalent graduate degree or two (2) full years of progressively higher level graduate education leading to such a degree or LL.B. or J.D., if related with a major study in hospital admin, public health admin, or related fields such as business or public admin with course work in health care admin. Education at the graduate level must demonstrate the knowledge, skills, and abilities necessary to do the work. OR Combination (Transcript Required): Your total qualifying experience and total qualifying education are each figured as a percentage of the experience and education required for the GS-09 level of the occupation being filled and the total of the two percentages must equal 100 percent to qualify. Only graduate education in excess of 1 year may be used to qualify applicants for positions at the GS-09.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. To qualify for this position at the GS-11 level, you must meet one of the following: Specialized Experience: You must possess at least one (1) full year of specialized experience that equipped you with the knowledge, skills, and abilities to successfully perform the duties of a Health System Specialist - Research Committee Manager and provided you with knowledge of the full scope of activities required to conduct single and multisite research in the areas of human subjects protection and Institutional Review Boards (IRB) through regulatory and policy compliance. To be creditable, specialized experience must have been equivalent to at least the next lower grade level (GS-9) in the normal line of progression for the occupation in the organization. Specialized experience includes 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; and knowledge of cognitive engineering, human factors engineering, human-computer interaction, or related fields. OR Education (Transcript Required): Successfully completed a Ph.D. or equivalent doctoral degree, three (3) full years of progressively higher level graduate education leading to such a degree, or LL.M. in the related field of the position to be filled (i.e., hospital administration, public health administration, or related fields such as business or public administration with course work in health care administration). The education portion must include courses that demonstrate the knowledge, skills, and abilities necessary to do the work of this position. Education must have been obtained in an accredited college, or university. OR Combination (Transcript Required): Combinations of successfully completed graduate level education (beyond a master's degree) and specialized experience as described above to meet total experience requirements. The education portion must include graduate courses that demonstrate the knowledge, skills, and abilities necessary to do to the work of this position (i.e., hospital administration, public health administration, or related fields such as business or public administration with course work in health care administration). You will be rated on the following Competencies for this position: Administration and Management Critical Thinking Project Management Research 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. 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. 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 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. Additional Information 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 VA Midwest Health Care Network advocates for a Whole Health System of care in each of the Medical Centers. This is an approach to healthcare that empowers and equips people to take charge of their health and well-being and live their lives to the fullest. As an employee operating in a Whole Health System of care, you will operate in a model with three core elements, seeking to create a personalized health plan for each Veteran. This is done in the context of healing relationships and healing environments and a connection back to the Veteran's community. This aligns with the Veterans Health Administration (VHA) Mission Statement to Honor America's Veterans by providing exceptional health care that improves their health and well-being. 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. 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/. 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. VA may offer newly-appointed Federal employee's credit for their job-related non-federal experience or active duty uniformed military service. 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. 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.