This position is located in the Comprehensive Research Oversight Workgroup (CROW) within the Veterans Health Administration (VHA) Office of Research Oversight (ORO) and reports to the CROW Workgroup Director. To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 03/20/2023. 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-13 position you must have served 52 weeks at the GS-12. 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. Quality Ranking Factors are skills, knowledge, abilities, or other worker characteristics which could be expected to result in superior performance on the job. Quality ranking factors will not be used for screening but may be used as ranking criteria. Applicants with higher proficiency levels may rank above those with lower proficiency levels on a quality ranking factor. A Quality Ranking Factor has been requested by the Program Office to help determine which of the basically qualified applicants are likely to be better qualified for a position. The quality ranking factors for this position are: An Advanced Degree (e.g., MS or PhD) in a biological, biomedical, health science, or similar field At least one year of experience equivalent to at least the next lower grade (GS-12) conducting biomedical or clinical research as a principal investigator in a healthcare setting, academic institution, or Federal agency (NOT including conducting research to fulfill degree requirements) One year of specialized experience equivalent to at least the next lower grade (GS-12) in one or more of the following areas: comprehensively directing all aspects of a human research protection program; leading site reviews to comprehensively evaluate research programs for compliance with regulations and policies pertaining to human research protections; and/or leading the auditing of research studies for compliance with regulations and policies pertaining to human research protections. You may qualify based on your experience and/or education as described below: Basic Education Requirement: Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in an academic field related to the health sciences or allied sciences appropriate to the work of the position. The number of semester hours required to constitute a major field of study is the amount specified by the college or university attended, or 24 semester hours if this number cannot be obtained. (Transcripts required) Specialized Experience: You must have one year of specialized experience equivalent to at least the next lower grade GS-12 in the normal line of progression for the occupation in the organization. Specialized experience is directing a human research protection program; conducting site reviews to evaluate research programs for compliance with regulations and policies pertaining to human research protections; auditing research studies for compliance with regulations and policies pertaining to human research protections; conducting research involving human subjects; directing the research operations of a research and development program; and/or serving as a voting member of an Institutional Review Board. You will be rated on the following Competencies for this position: Analytical Reasoning Compliance and Auditing Methodologies Communication Data Analysis Risk Management Technical Competence 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: 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. Physical Requirements: The work is sedentary. Typically, the employee may sit comfortably to perform portions of the work. However, there is periodic walking, standing, bending, carrying of light items such as research records, instructional material, books, manuals, and laptop computer. No special physical demands are required to perform the work; however, travel forms a significant component of the program. 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/. ["The primary purpose of the position is to provide oversight of VHA facilities with research programs to ensure compliance with VA and other Federal regulatory and policy requirements pertaining to the conduct of human subjects research and human subject protections and general research administration. The position specializes in compliance oversight pertaining to the conduct of human subjects research and human subject protections and general research administration. The CROW Workgroup is responsible for: (i) performing periodic prospective reviews of VA medical facility research programs to ensure compliance with applicable laws, regulations, and policies pertaining to the conduct of human subjects research and human subject protections and general research administration; (ii) performing for cause reviews into serious concerns raised about VA medical facilities' research oversight programs or specific research studies when it is determined that such concerns are best investigated independently of the VA medical facility; (iii) reviewing VA research-related incidents required to be reported to ORO, including reports of unanticipated problems and serious or continuing noncompliance with the laws, regulations, and policies applicable to human subject protections and general research administration; (iv) providing oversight of VA medical facility remediation efforts to resolve noncompliance identified by ORO and/or required to be reported to ORO; (v) providing technical assistance and information to VA medical facility research programs and other audiences, as appropriate, to enhance and promote research compliance; (vi) supporting ORO- and VHA-wide efforts to identify frequent noncompliance issues and trends in noncompliance; (vii) collaborating with other Federal, VA and VHA offices regarding the interpretation of policies and procedures related to human subject protections and general research administration; and (viii) collaborating with other Federal, VA and VHA offices regarding the development of Federal governmentwide policies, procedures, and guidance related to human subject protections and general research administration. Major Duties Include: Participates in or leads the evaluations of Human Research Protection Programs, Research & Development Committees, general research administration activities, and Research Compliance Officer auditing practices to assess for programmatic compliance and vulnerabilities.. Provides primary subject matter expertise in the areas of human research protections and general research administration activities pertaining to the review, conduct, and oversight of VA research. Interacts with personnel at VA facilities to clarify research compliance issues, provide advice and technical assistance, and arrange on-site reviews of research programs. Analyzes review and evaluation data, providing recommendations for program strategies, modifications, or improvements. Applies research and auditing inspection techniques to extract information that can be used to evaluate research programs. Keeps up-to-date on emerging issues in research compliance. Evaluates policies and proposed, new, or modified legislation to determine its impact on human research protections, Research and Development Committees, general research administration, and Research Compliance Officer auditing practices. Represents the agency on major working groups and committees dealing with issues related to research compliance. Makes programmatic and policy interpretations, collects and analyzes data, and presents results through presentations and/or publications. Develops integrated systematic strategies to meet short, medium, and long-term goals for very complex and controversial health research compliance programs. Produces oral and written reports on highly complex technical matters of a scientific or regulatory nature and effectively communicate the information to audiences with varying backgrounds. Maintains and securely stores records. 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 Compressed/Flexible: Available Virtual: This is a virtual position. Position Description/PD#: Health Science Specialist/PD97877A Relocation/Recruitment Incentives: Not authorized Permanent Change of Station (PCS): Not authorized Financial Disclosure Report: Required"]
About Veterans Affairs, Veterans Health Administration
Providing Health Care for Veterans: The Veterans Health Administration is America’s largest integrated health care system, providing care at 1,255 health care facilities, including 170 medical centers and 1,074 outpatient sites of care of varying complexity (VHA outpatient clinics), serving 9 million enrolled Veterans each year.