This position is aligned within the Research and Development department located at the Veterans Healthcare System in San Francisco, CA. The primary function of this position is to oversee, review, process and track applications to completion for all human subjects studies performed at the SFV AMC. The position coordinates multiple complex projects and responds to multiple competing demands for resources.

Duties

** THIS IS NOT A VIRTUAL/REMOTE POSITION. Telework may be authorized for a highly qualified candidates but is not a guarantee. Determination will be made during the selection process. Advertised salary is based on San Francisco locality pay. Salary range is dependent upon physical location of selectee. ** This position involves a multi-grade career ladder. The major duties listed below represent the full performance level of GS-12. At the GS-11 grade level, you will perform assignments of a more limited scope and with less independence. You will progressively acquire the background necessary to perform at the full performance level of GS-12. Promotion is at the discretion of the supervisor and is contingent upon satisfactory performance, availability of higher-level work, and availability of funds. Duties will include but may not be limited to the following: Oversees, reviews, and processes applications to completion for all human subject research (HSR) studies. Analyzes submissions (initial applications, modifications, correspondence, renewals, other relevant documents) for conformance with regulations, statue statutes, policies and procedures regarding HSR, data privacy (HIPAA), and conflict of interest. Maintains records according to applicable regulatory requirements. Provides advice on and answers questions about administrative and technical matters where the guidance/regulations are unclear or non-existent regarding the applications (no scientific review required) from Principal Investigators (PIs) and clinical research staff. Attends IRB and Research Committee meetings, ensuring that changes or additional information required before committee review or final approval are communicate to study teams. Recommends changes in staffing and procedures where necessary to conform to federal and state laws, regulations, and guidance of applicable federal agencies. Reviews, analyzes, and corresponds with study teams in corrective actions regarding HRPP protocol violations and other reportable events through IRB reporting systems. Utilizes Microsoft Office Suite (Word, Excel, Power Point, Access, etc.) to create documents, spreadsheets, databases and for electronic mail correspondence. Performs other duties as necessary. Work Schedule: Monday-Friday, 8:00am - 4:30pm Recruitment & Relocation Incentives: Not authorized Critical Skills Incentive (CSI): Not Approved Telework: May be eligible for highly qualified candidate; 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.

Requirements

Qualifications

SELECTIVE PLACEMENT FACTOR (SCREEN-OUT) - A Selective Placement Factor (SPF) has been identified for this position. Selective Placement Factors (SPF) are a prerequisite to appointment and represent minimum requirements for the position. Applicants who do not meet the SPF are ineligible for further consideration. The SPF for this position is: Experience in a hospital/healthcare setting performing the initial intake of IRB applications; executing application reviews for correction/errors; ensuring compliance of all required forms and documents; and making modifications in relation to policies and procedures for IRB submission related to human research. In addition to the SPF, applicant(s) must possess qualifications described below for the grade level(s). GS-11 SPECIALIZED EXPERIENCE: Requires one full year of specialized experience that equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled. 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: attending clinical research committee meetings and ensuring that changes or additional information required before committee review or final approval are communicated to study teams; using Microsoft Office Suite (Word, Excel, Power Point, Access, Electronic mail, etc.) to create documents, spreadsheets, databases and for electronic mail correspondence, and must have documented experience of patient contact performing data collection such as chart reviews, abstractions, consenting patients, and scientific data collection involving human subjects (medical and/or psychological). NOTE: Applicants wishing to receive credit for such experience must clearly indicate the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment. -OR- GS-11 EDUCATION: Successfully completed 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. Such education must demonstrate the knowledge, skills, and abilities necessary to do the work. (TRANSCRIPT REQUIRED) -OR- GS-11 COMBINATION: Equivalent combinations of successfully completed Graduate education in excess of 2 years and specialized experience may be used to meet total qualification requirements. (TRANSCRIPT REQUIRED): GS-12 SPECIALIZED EXPERIENCE: Requires one full year of specialized experience that equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled. To be creditable, specialized experience must have been equivalent to at least the next lower grade level (GS-11) in the normal line of progression for the occupation in the organization. In addition to the specialized experience for the lower grade above, additional specialized experience for this grade includes: reviewing, analyzing, and corresponding with study teams in corrective actions regarding HRPP protocol violations and other reportable events through IRB reporting systems; reviewing complex policy, patient safety, and regulatory procedural guidance, surrounding initial institutional review board (IRB) applications, modifications, adverse events, and renewals for conformance with federal, state and local policies and procedures; identifying, suggesting and rewriting corrective actions for protocol violations, serious adverse events and privacy/security violations; and makes recommendations offering HRPP privacy and protocol improvement suggestions. NOTE: Applicants wishing to receive credit for such experience must clearly indicate the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment You will be rated on the following Competencies as part of the assessment questionnaire for this position: CommunicationsComplianceCritical ThinkingProject Management 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). 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. Physical Requirements: Phys: The work is sedentary. Typically, the employee may sit comfortably to perform all portions of the work. However, there is periodic walking, standing, bending, carrying of light items such as medical records, instructional material, books and manuals. No special physical demands are required to perform the work. 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

IMPORTANT: A transcript must be submitted with your application if you are basing all or part of your qualifications on education.

There is no educational substitution at the GS-12 grade level.

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: Recognition of Foreign Qualifications | International Affairs Office (ed.gov).

Contacts

• Address San Francisco VA Medical Center 4150 Clement Street San Francisco, CA 94121 US
• Name: VHA National Recruitment Center
• Phone: (844)456-5208
• Email: [email protected]