This position serves as the Research Compliance Officer and the Research Integrity Officer for the Research & Development Program under the Medical Center Director. The incumbent is responsible for the oversight of research compliance and training activities for the Research Program. The incumbent provides guidance and counsel on incorporating compliance-related activities into the day-to-day operations of the Research & Development Service.

Duties

Work Schedule: Monday - Friday; 8:00 a.m. - 4:30 p.m.; Tour of duty subject to change to meet the needs of the Agency Telework: Ad hoc telework may be authorized. Virtual: This is not a virtual position. Position Description/PD#: Program Specialist/02880-O Relocation/Recruitment Incentives: Not Authorized Permanent Change of Station (PCS): Not Authorized Financial Disclosure Report: Not required Major Duties: The primary function of incumbent is to work closely with the Director's Office, subordinates, and investigators to ensure compliance with laws and regulations promulgated to ensure the protection of human subjects in research. He or she will serve as the primary resource person concerning compliance issues in accordance with the "Common Rule" (45 CFR 46 & 38 CFR 16). Specific focus will include the Department of Health and Human Services (DHHS), National Institutes of Health (NIH), Food and Drug Administration (FDA), and VA policies. The incumbent will be required to communicate with researchers both verbally and in writing to advise them on policy matters, process issues, and procedural requirements for conducting research involving humans, animals, and biosafety. He or she will develop and revise, as necessary, written procedure documents implementing the regulations. The incumbent will review all research projects involving human subjects, including thorough review of all informed consent documents; animal subjects; and biosafety. In addition, the incumbent will develop compliance training programs, ensuring they meet regulatory requirements, is modified to include current information and is completed by appropriate staff members. The incumbent will develop plans and programs for achieving and maintaining total research compliance within a research environment. Development of Programs, Policies, and Procedures The incumbent will develop and supervise programs to ensure that compliance goals are developed and implemented to identify, prevent and correct unsatisfactory conditions and elements which influence the regulatory correctness and responsiveness of protocols. The incumbent will develop and supervise data capture and reporting procedures to track progress of quality program management initiatives. The incumbent will identify indicators, progress measures, objectives and emphasis areas for the attention of committee chairs and members. He or she will develop and review training materials, presentations and information packages for the Research & Development's compliance and assurance program. Based on samples or guidance from senior staff, develops materials to convey program information to target audience. Development of Criteria The incumbent will develop and supervise reporting procedures, sampling techniques, and measurements at various points in the business cycle to identify problem areas or inherent weaknesses in work processes, procedures, information system and content. He or she will develop indicators to provide objective evidence of effectiveness of quality procedures and controls. The incumbent will identify operational activities that meet, exceed or fail to meet established criteria. He or she will use standard qualitative and quantitative measurement techniques to report on status of research compliance. Program Implementation The incumbent will investigate and analyze adverse quality trends or conditions and initiates corrective action. Consults with technical experts to examine and analyze usual or problem situations indicated by changes in program quality indicators. Performs in-depth research, analyzes operating contingencies and special situations. The incumbent will monitor qualitative and quantitative measurements to identify compliance program trends. He or she will identify areas requiring further analysis. Recommends approach to senior staff. Audits, Inspections, and Management Controls 10 percent The incumbent will perform and oversee audits of local, investigators as part of the institutional quality assurance procedures specified by the Research and Development Committee and Subcommittees. Evaluates results of audits/inspections and forwards action to the responsible organization. Training and Education The incumbent will design training programs and organizational strategies for identifying opportunities to improve compliance. Perform annual training for investigators involved in human studies, animal studies, and biosafety. Database Management and Analysis The incumbent will supervise the administrative update of the research database systems; this includes the Management Institutional Review Board (MIRB) database, and the Promise system database.

Requirements

Qualifications

To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 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-12 position you must have served 52 weeks at the GS-11. 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. You may qualify based on your experience as described below: One year of specialized experience that equipped you with particular knowledge, skills, and abilities (KSAs) to successfully perform the duties of the position, and that is typically in or related to the position to be filled. [To be creditable, the specialized experience must have been at the GS-11 grade level or higher, or an equivalent level of responsibility. Examples of creditable specialized experience includes: Knowledge of pertinent laws, regulations, and policies related to biosafety and to the use of human and animal subjects in research. Knowledge and skill in adapting analytical techniques and evaluation criteria to the measurement and improvement of program effectiveness and/or organizational productivity. Knowledge and regulations within this field requires understanding and interpreting a wide range of professional literature and regulation. Ability to communicate orally and in writing with researchers to advise them on policy matters, process issues, and procedural requirements that facilitate compliance when conducting research. You will be rated on the following Competencies for this position Auditing, Communication, Customer Service, Decision Support, and Manages and Organizes Information 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. 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/. Physical Requirements: The work is primarily sedentary, although some slight physical effort may be required.

Education

There is no educational substitution at this 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: http://www.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html.

Contacts

• Address Fresno VA Medical Center 2615 East Clinton Avenue Fresno, CA 93703 US
• Name: Gerald Collier
• Phone: 317-354-5465
• Email: [email protected]