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.

Duties

R&D, IRB, IACUC, SRS, CIRB, IBC, 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, animals, 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 Institutional Review Board (IRB), Institutional Animal Care and Use Program (IACUC), Subcommittee on Research Safety (SRS), Institutional Biosafety Committee (IBC), Central Institutional Review Board (CIRB), and/or Research & Development (R&D) Committee review of all research involving human subjects, animal subjects, basic laboratory science and the human research protection program. Develops and manages required annual and semi-annual reviews of the assigned programs. Educates the investigative community of local and external policies and procedures with regards to research involving animal and 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. Responsible for maintaining the IBC registration with the National Institutes of Health Office of Science Policy and ensuring IBC is appropriately constituted and registered. Responsible for maintaining the program's accreditation process for the Association for the Assessment and Accreditation for Laboratory Animal Care International (AAALAC) and federal assurance for the use of research animals through the Office of Laboratory Animal Welfare (OLAW). 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), ORO, and other applicable regulatory and procedural requirements. Develops programs, policies, and procedures within the R&D 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/audits. Research and/or analyzes problems, administrative issues, or program requirements as they relate to animal, human subject 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. Manages and provides oversight, support and training to committee members and research investigators in the use of research committee management software(s). Work Schedule: Full-time, Monday-Friday, 8:00am-4:30pm Position Description Title/PD#: Health System Specialist/PD99586S Physical Requirements: The work is primarily sedentary, although some slight physical effort may be required. 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.

Requirements

• You must be a U.S. citizen to apply for this job
• Subject to a background/suitability investigation
• May serve a probationary period
• Selective Service Registration is required for males born after 12/31/1959
• A complete application package; Resume, Transcripts, etc.
• Selected applicants will be required to complete an online onboarding process

Qualifications

To qualify for this position, applicants must meet all requirements by the closing date of this announcement. Basic Requirement: The occupational series 671 includes an Individual Occupational requirement (IOR). Candidates may not hold a position in this series without meeting one of the following IOR requirements. Undergraduate and Graduate Education: major study in hospital administration, public health administration, or related fields such as business or public administration with course work in health care administration. (Transcripts Required) OR, Experience: 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:- Missions, organizations, programs, and requirements of health care delivery systems;- Regulations and standards of various regulatory and credentialing groups; and- Government-wide, agency, and facility systems and requirements in various administrative areas such as budget, personnel, and procurement. Experience must be detailed in your resume to receive credit. OR, Special Provision for In-service Placement: Successful completion of an agency-sponsored on-the-job training program may be substituted for qualifying experience, provided it included a formal individualized training plan. Such a training program must have been conducted in an operating health care system and included: assignments providing a knowledge of basic health system administration philosophies, practices, and procedures, and basic government administrative policies and requirements; practical assignments providing an opportunity to apply health system administration skills and principles and oversight by an experienced health system administrator with periodic evaluation of the individual's progress and appropriate adjustment of the training program. AND Specialized Experience GS-09 grade level: 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: Overseeing and managing research programs and their activities; Applying qualitative and/or quantitative methodologies, and techniques of analysis and evaluation; Utilizing a variety of technical applications, such as Microsoft Office. OR Education: Successfully completed a master's or equivalent graduate degree or successfully completed two (2) full years of progressively higher level graduate education leading to such a degree. Such education must demonstrate the knowledge, skills, and abilities necessary to do 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). 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: Transcripts must be submitted with your application materials. Education cannot be credited without documentation. OR 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. GS-11 grade level: Experience: One year of specialized experience (equivalent to the GS-9 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: 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. Experience must be detailed in your resume to receive credit. OR, Education: Applicants may substitute education for the required specialized experience. To qualify based on education for this grade level you must have a Ph.D. or equivalent doctoral degree, or 3 full years of progressively higher level graduate education leading to such a degree, or LL.M., if related. (Transcripts Required) Combination: Applicants may also combine education and experience to qualify at this level. You must have an equivalent combination of successfully completed graduate education and specialized experience, as described above, which meets the total qualification requirement for the GS-11 grade level. (TRANSCRIPT REQUIRED) (When crediting education that requires specific course work, prorate the number of hours of related courses required as a proportion of the total education to be used.). 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.

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.

Contacts

• Address VA New Jersey Health Care System 385 Tremont Avenue East Orange, NJ 07018 US
• Name: Karl McPherson
• Phone: 518-466-6400
• Email: [email protected]