The Program Specialist serves as the Research Compliance Officer (RCO) with primary responsibility for compliance activities for research overseen by the Research and Development (R&D) Program at the James H. Quillen VA Medical Center (JHQVAMC). JHQVAMC is a tertiary, integrated healthcare system comprised of one major hospital campus at Mountain Home, TN and many CBOCs.

Duties

Duties include but are not limited to: The incumbent evaluates compliance with Federal and VA requirements for the conduct of research, which may include requirements in one or more of the following areas: the protection of human research subjects, laboratory animal welfare, and research safety and security. The incumbent may also be assigned responsibilities related to facility programs for research information security, research privacy, conflict of interest in research, training of research personnel. research program accreditation, research misconduct, and/or other research compliance activities consistent with VHA requirements. The incumbent adds value to the organization through improvement of research processes. Compliance monitoring provides internal oversight on quality and compliance issues relating to the performance of clinical research trials involving human subjects as well as conduct of animal and science-safety trials. The incumbent is responsible for providing JHQV AMC leadership with reasonable assurances that HRPPs comply with VA and Federal Regulations. Research Compliance also includes oversight of animal research, basic research, and safety programs. The incumbent provides leadership, expertise, and strategic direction for the facility's research compliance program, and is responsible for developing, implementing, and maintaining compliance oversight activities in assigned areas of responsibility. The incumbent develops strategy, policy and/or standards covering the facility's research compliance program activities and records. Analyzes and evaluates the effectiveness of programs or operations in meeting established compliance goals and objectives. Analyzes program performance data to identify trends and impact. The incumbent analyzes, prepares and distributes research compliance program status reports. The incumbent performs ongoing research monitoring and auditing in assigned areas of responsibility. These activities must be consistent with VHA research monitoring and auditing requirements, and require the ability to conduct in-depth review and analysis of research, clinical, and training records relevant to the assigned areas of responsibility. Monitoring and auditing reports are timely. accurate, and complete; reports are provided to facility leadership and others in accordance with VHA requirements. The incumbent conducts routine and "for cause" reviews as well as performance improvement activities to promote compliance, reduce violations of regulations and standards, identify unsatisfactory trends and conditions, and identify and communicate factors that may contribute to non-compliance. The incumbent evaluates audits and inspections, and forwards action items to the responsible individual and/or organization (e.g., FDA, ORO, OHRP, VA). Performs audits of research records related to human subject and animal subject protections. Maintains audit records as required for compliance and derives routine analyses of trends from those records. Maintains research compliance records in conditions suitable for ORO, FDA, ORD, USDA or AAALAC inspections. The incumbent evaluates and updates standard operating procedures (SOPs) to maintain compliance with applicable Federal regulations and accreditation requirements. Provides advice regarding the research compliance content of their SOPs. 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 to Friday 8:00am to 4:00pm Telework: ADHOC, as determined by policy Virtual: This is not a virtual position. Position Description/PD#: Program Specialist/PD60556-0 Relocation/Recruitment Incentives: Not Authorized Critical Skills Incentive (CSI): Not Approved Permanent Change of Station (PCS): 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, 09/09/2024. 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-11 position you must have served 52 weeks at the GS-09. 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 and/or education as described below: Specialized Experience: You must have one year of specialized experience equivalent to at least the next lower grade GS-09 in the normal line of progression for the occupation in the organization. Examples of specialized experience would typically include, but are not limited to: Knowledge and experience commensurate with grade level in performing verifiable research auditing that utilizes accepted national and VA methods for auditing of research projects Knowledge of nationally recognized auditing and monitoring systems, as well as of applicable laws, regulations, and policies. Must require knowledge and skills in applying analytical and evaluative techniques to the identification, consideration, and resolution of issues or problems of a procedural or factual nature. Knowledge of Human Subjects Protection principles, regulations, standards, and procedures, as well as an understanding of the business dynamics which affect medical research. Knowledge of the range of administrative laws, policies, regulations, and precedents applicable to the administration of the JHQVAMC research program. Knowledge of a wide range of concepts, principles, and practices of a professional or administrative occupation, such as would be gained through extended study or experience, and skill in applying this knowledge to difficult and complex work assignments. Demonstrates commitment to the team decision- making process. Complies with all safety/fire prevention rules/regulations, using protective equipment when required and provided. Knowledge in MS PowerPoint or other comparable graphics software to develop presentation materials. Must have knowledge and experience with of the Veterans Health Information & Technology Architecture (VistA) and other online tools to access information in the Medical Center Computer System. OR, Education: Applicants may substitute education for the required experience. To qualify based on education for this grade level you must have 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. related to the work of this position (TRANSCRIPTS REQUIRED). OR, Combination: Applicants may also combine education and experience to qualify at this level. You must have an combination of specialized experience and education beyond the second year of graduate level education but less than the time required for the degree pursued. To calculate, first take the number of months of specialized experience and divide that by 12, then take the number of semester hours beyond the second year and divide that by the number of semester hours required for your degree. Add these two percentages together and this must equal or exceed 100%. You will be rated on the following Competencies for this position: AuditingCommunicationComplianceIntegrity/HonestyManages and Organizes InformationQuality AssuranceResearchStandards 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: Work is mainly sedentary. Traveling off station to other sites of care or various meetings is necessary and working overtime and odd hours, to include weekends may be necessary. There may be some walking, standing, bending, carrying of light items, such as instructional material, manuals, papers, and books. Infrequent official travel such as annual research conferences or possible VISN level conferences in Nashville, TN. 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

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

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: https://sites.ed.gov/international/recognition-of-foreign-qualifications/.

Contacts

• Address James H Quillen VA Medical Center Corner of Lamont Street and Veterans Way Mountain Home, TN 37684 US
• Name: Paulette Stewart
• Email: [email protected]