Health System Specialist - Research Committee Manager

Not Required

Duties

The Research Committee Manager 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: 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 IRB, IACUC, SRS, IBC, CIRB, and/or 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. 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 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). 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 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 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. Work Schedule: Monday - Friday, 8:00am - 4:30pm Telework: Ad -hoc Position Description Title/PD#: Health System Specialist - Research Committee Manager/PD99586S 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.

Requirements

You must be a U.S. citizen to apply for this job Subject to a background/suitability investigation Selective Service Registration is required for males born after 12/31/1959 A complete application package; Resume, Transcripts, etc. is required Selected applicants will be required to complete an online onboarding process. Acceptable form(s) of identification will be required to complete pre-employment requirements (https://www.uscis.gov/i-9-central/form-i-9-acceptable-documents). Effective May 7, 2025, driver's licenses or state-issued identification cards that are not REAL ID compliant cannot be utilized as an acceptable form of identification for employment. Upon completion of your probationary period, your employment will be terminated unless you receive certification, in writing, that your continued employment advances the public interest. As a condition of employment for accepting this position, you will be required to serve a 1-year probationary period during which we will evaluate your fitness and whether your continued employment advances the public interest. In determining if your employment advances the public interest, we may consider: your performance and conduct; the needs and interests of the agency; whether your continued employment would advance organizational goals of the agency or the Government; and whether your continued employment would advance the efficiency of the Federal service Upon completion of your probationary period or trial period, your employment will be terminated unless you receive certification, in writing, that your continued employment advances the public interest.

Qualifications

To qualify for this position, applicants must meet all requirements by the closing date of this announcement. 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 in the areas of human subject protection, biosafety, Institutional Review Boards (IRB), Institutional Animal Care and Use Committees (IACUC), and 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 SUBSTITUTION OF 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. NOTE: Copies of transcripts must be submitted with your application materials. Education cannot be credited without documentation. OR COMBINING EDUCATION AND EXPERIENCE (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). NOTE: Copies of transcripts must be submitted with your application materials. Education cannot be credited without documentation. 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.

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. NOTE: If your school has changed names, or is no longer in existence, you must provide this information in your application.

Other 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. A 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. Participation in the seasonal influenza program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). It is a requirement that all HCP to receive annual seasonal influenza vaccination or obtain an exemption for medical or religious reasons. Wearing a face mask is required when an exemption to the influenza vaccination has been granted. HCP in violation of this directive may face disciplinary action up to and including removal from federal service. HCP are individuals who, during the influenza season, work in VHA locations or who come into contact with VA patients or other HCP as part of their duties. VHA locations include, but are not limited to, VA hospitals and associated clinics, community living centers (CLCs), community-based outpatient clinics (CBOCs), domiciliary units, Vet centers and VA-leased medical facilities. HCP include all VA licensed and unlicensed, clinical and administrative, remote and onsite, paid and without compensation, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, researchers, volunteers and health professions trainees (HPTs) who are expected to perform any or all of their work at these facilities. HPTs may be paid or unpaid and include residents, interns, fellows and students. HCP also includes VHA personnel providing home-based care to Veterans and drivers and other personnel whose duties put them in contact with patients outside VA medical facilities. 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. 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.