Lake Nona facility is recruiting a Research Compliance Officer for the Research & Development Program. Evaluates the functioning of the Human Research Protection Program and the safeguards in place to protect human research subjects in VA Research Department. Research Compliance also includes oversight of animal research, basic research and safety programs. Provides internal oversite conducting audits of each research project involving human subjects.

Duties

The RCO must possess an in-depth mastery and knowledge of interrelated federal and state laws and regulations. VA and VHA requirements governing 1 or more of the following, and must have basic working knowledge of all 3 areas: Protection of Human Subjects in Research. Laws, regulations, standards, policies related to human research protection and applicable VA, VHA Directives, Handbooks, and policies. Federal Policy "Common Rule" for the Protection of Human Research Subjects. Duties include but are not limited to: Thorough knowledge of Human Subjects Protection principles, regulations, standards, and procedures, as well as an understanding of the business dynamics which affect medical research. Addressing VA's wide range of research activities (e.g., pharmaceutical, mental health, health services, social sciences, physical health, tumor and tissue research, behavioral and other non-biomedical methods, animal research, and laboratory research). Protection of human research subjects, laboratory animal welfare, and research safety and security. Conducting human subjects' research to audit each research project involving human subjects. Performs audits of research records related to human subject and animal subject protections. Maintains research compliance records in conditions suitable for ORO, FDA, ORD, USDA or AAALAC inspections. Responsible for providing Facility leadership with reasonable assurances that HRPP Programs comply with VA and Federal Regulations. Knowledge of the laws, regulations, standards, and policies related to research safety and security, including (but not limited to) Biosafety in Microbiological and Biomedical Laboratories (Center for Disease Control and Prevention/National Institutes of Health). Guidelines for Research Involving Recombinant DNA Molecules (National Institutes of Health). Department of Transportation regulations for shipping and transferring materials (42 CFR 72). Advises Services and investigators regarding the research compliance content of their SOPs. Administer, direct, or inspect activities to assure full compliance in each of the five compliance programs human studies, animal studies, laboratory safety and radiation safety, conflict of interest, information security and privacy. Communications and writing skills are critical to interface effectively with senior staff, researchers, the affiliated university (if applicable), and a variety of administrative staff on and off campus. Analyzes, prepares and distributes research compliance program status reports. Follows cases of research noncompliance through resolution actions and closure. Completes other duties as assigned. Work Schedule: 8:00 AM - 4:30 PM Monday - Friday Telework: Eligible Virtual: This is not a virtual position. Position Description/PD#: Program Specialist (Research Compliance Officer)/PD064620 Relocation/Recruitment Incentives: Authorized Critical Skills Incentive (CSI): Not authorized Permanent Change of Station (PCS): Not authorized PCS Appraised Value Offer (AVO): Not authorized Financial Disclosure Report: Not required

Requirements

Qualifications

To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 10/26/2023. 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-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: Specialized Experience: You must have one year of specialized experience equivalent to at least the next lower grade GS-11 in the normal line of progression for the occupation in the organization. Examples of specialized experience would typically include, but are not limited to: Uses a wide-range of teaching methods or tools, depending on the students' learning requirements. Thorough knowledge of Human Subjects Protection principles, regulations, standards, and procedures, as well as an understanding of the business dynamics which affect medical research. Addressing VA's wide range of research activities (e.g., pharmaceutical, mental health, health services, social sciences, physical health, tumor and tissue research, behavioral and other non-biomedical methods, animal research, and laboratory research). Protection of human research subjects, laboratory animal welfare, and research safety and security. Conducting human subjects' research to audit each research project involving human subjects. Performs audits of research records related to human subject and animal subject protections. Maintains research compliance records in conditions suitable for ORO, FDA, ORD, USDA or AAALAC inspections. Responsible for providing Facility leadership with reasonable assurances that HRPP Programs comply with VA and Federal Regulations. Advises Services and investigators regarding the research compliance content of their SOPs. You will be rated on the following Competencies for this position: Administration and ManagementEducation and TrainingLeadershipResearchTeamwork 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 primarily sedentary, although some slight physical effort may be required. 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

There is no educational substitution at this grade level.

Contacts

• Address Orlando VA Medical Center 13800 Veterans Way Orlando, FL 32827 US
• Name: Sally Jordan
• Phone: 813-919-9130
• Email: [email protected]