USAJOBS · 2 months ago
Health System Specialist-Research Committee Manager
USAJOBS is seeking a Health System Specialist-Research Committee Manager for the Veterans Health Administration at the Salem VA Medical Center. This role involves providing high-level analytical and procedural support for research projects, ensuring compliance with regulatory standards, and managing multiple regulatory committees.
ConsultingGovernmentHuman ResourcesInformation TechnologyInternetStaffing Agency
Responsibilities
Serve as the Program Manager and Specialist for multiple regulatory committees
Provide oversight of the entire review process of research protocols involving animal and/or human subjects
Ensure that all respective committee actions and procedures are within the scope of all applicable local, Office of Research and Development (ORD), Office of Research Oversight (ORO), Office of Laboratory Animal Welfare (OLAW), Office of Safety and Health Administration (OSHA), USDA, and Food and Drug Administration (FDA)
Provide information to the respective regulatory research committees regarding ever-changing and evolving regulations
Apply analytical and evaluative methods and techniques to research issues or studies and oversee and manage these programs and their activities
Develop and maintain a pre-review program that coincides with IRB, IACUC, and R&D Committee review of all research involving human, animal subjects, basic laboratory science and the human research protection program
Develop and maintain required annual and semi-annual reviews of assigned programs
Provide review of ORD studies
Educate the investigative community of local and external policies and procedures about research involving animal and human subjects
Develop reporting procedures
Maintain the federal-wide assurance with the Office of Human Research Protection
Maintain the IBC registration with the National Institutes of Health Office of Science Policy
Maintain accreditation process for AAALAC
Analyze and evaluate each research project to ensure compliance with Federal and State regulations
Develop programs, policies, and procedures with the Research Office
Monitor quality assurance program implementation
Conduct quality improvement activities, special projects, or studies
Prepare all external reviews for FDA, USDA, ORO, AALAC, etc
Perform in-depth research and/or analyze problems, administrative issues, or program requirements about animal, human subjects or safety research
Provide advice/consultation to IRB, IACUC, and R&DC chairs, members and staff on ethical principles, laws and regulations
Design and studies training programs
Serve as electronic records system administrator
Qualification
Required
You must be a U.S. Citizen to apply for this job
Selective Service Registration is required for males born after 12/31/1959
Subject to background/security investigation
Selected applicants will be required to complete an online onboarding process. Acceptable form(s) of identification will be required to complete pre-employment requirements
Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP)
To qualify for this position at the GS-11 grade level, you must have at least one (1) year of specialized experience directly related to this position
Specialized experience includes progressively responsible analytical or administrative, or clinical management or supervisory experience in the health care field
Work must have involved a close working relationship with facility managers and analysis and/or coordination of administrative, clinical, or other service activities
Provide 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
The experience required at this level is performed under general supervision, very difficult and responsible work along special technical or administrative lines in office, business, or fiscal administration requiring specialized training and considerable administrative experience which demonstrated capacity for sound independent work
Specialized experience also includes functioning as the Program Manager and Specialist for multiple regulatory committees, provide oversight of the entire review process of research protocols involving animal and/or human subjects, ensure that all respective committee actions and procedures are within the scope of all applicable local, Office of Research and Development (ORD), Office of Research Oversight (ORO), Office of Laboratory Animal Welfare (OLAW), Office of Safety and Health Administration (OSHA), USDA, and Food and Drug Administration (FDA), develop and maintain required annual and semi-annual reviews of assigned programs, educate the investigative community of local and external policies and procedures about research involving animal and human subjects, develop programs, policies, and procedures with the Research Office, monitor quality assurance program implementation
You may substitute specialized experience with education if you have a Ph.D. or equivalent doctoral degree or three (3) full years of progressively higher-level graduate education leading to a Ph.D
This education must demonstrate the knowledge, skills, and abilities necessary to do the work
Examples: hospital administration, public health administration, or related fields such as business or public administration with course work in health care administration
A copy of your transcript(s) is required
Equivalent combinations of education and specialized experience (as described above) may also be used to meet the requirements
A copy of your transcript(s) is required
You will be rated on the following Competencies as part of the assessment questionnaire for this position: Administration and Management, Critical Thinking, Project Management, Research
IMPORTANT: A full year of work is considered to be 35-40 hours of work per week
All experience listed on your resume must include the month and year start/end dates
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; religious; spiritual; community; student; social)
You will receive credit for all qualifying experience, including volunteer experience
Physical Requirements: The work is primarily sedentary, although some slight physical effort may be required
The work is typically performed in an adequately lighted and climate-controlled office
May require occasional travel
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
Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education
Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating
Benefits
A career with the U.S. government provides employees with a comprehensive benefits package.
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent.
Company
USAJOBS
USAJOBS enables federal job seekers to access job opportunities across hundreds of federal agencies and organizations.
Funding
Current Stage
Late StageRecent News
Company data provided by crunchbase