This position serves as Health System Specialist - Research Committee Manager (IRB Administrator) 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.

Duties

The IRB Administrator position is vital within the ORD and the facilities where research programs are conducted. Research Program Managers provide the link between Veterans and highly innovative projects. Duties and responsibilities include but are not limited to: IRB 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, and safety procedures 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 System and 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 IRB, IACUC, SRS, IBC, CIRB, 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 Analyzes and evaluates each research project to ensure compliance with Federal and State regulations, including but not limited to VA, FDA, ORO, and other applicable regulatory and procedural requirements. Develops programs, policies, and procedures within the Research. 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. Research and/or analyzes problems, administrative issues, or program requirements as they relate to , human subjects or safety 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. Work Schedule: Monday-Friday, 7:00 a.m.-3:30 p.m. Compressed/Flexible: Supervisor's Discretion 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. Virtual: This is not a virtual position. Position Description/PD#: Health System Specialist (IRB Administrator)/PD99586S Relocation/Recruitment Incentives: Not Authorized Permanent Change of Station (PCS): Not Authorized Financial Disclosure Report: Not required

Requirements

Qualifications

To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 10/21/2023. 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-11 position you must have served 52 weeks at the GS-09. 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. If the most recent SF-50 has an effective date within the past year, it may not clearly demonstrate you possess one-year time-in-grade, as required by the announcement. In this instance, you must provide an additional SF-50 that clearly demonstrates one-year time-in-grade. Note: 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. You may qualify based on your experience and/or education as described below: 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 and provided you with knowledge of the full scope of activities required to conduct single and multisite research under purview of R&D Committees 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): Applicants may substitute education for the required experience. To qualify based on education for this grade level you must have 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. NOTE: Copies of transcripts must be submitted with your application materials. Education cannot be credited without documentation. OR, Combination (Transcript required): Applicants may also combine education and experience to qualify at this level. You must have an combination of specialized experience and education beyond. 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). NOTE: Copies of transcripts must be submitted with your application materials. Education cannot be credited without documentation. You will be rated on the following Competencies for this position: Administration and ManagementCritical ThinkingProject ManagementResearch 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: NOTE: One (1) 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. NOTE: One (1) year of full-time graduate education is considered to be the number of credit hours that the school attended has determined to represent one (1) year of full-time study. If that number cannot be obtained from the school, eighteen (18) semester hours will be considered an academic year of graduate study. Part-time graduate education is creditable in accordance with its relationship to a year of full-time study at the school attended. 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. 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. For further information, visit: http://www.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html.

Contacts

• Address Carl T Hayden Veterans' Administration Medical Center 650 East Indian School Road Phoenix, AZ 85012 US
• Name: Roberto Mejia
• Email: [email protected]