The Program Specialist - Research Compliance Officer , is located in the Director's Office of the VA Pittsburgh Healthcare System. Responsible for providing a strategic direction and developing, implementing, and documenting a comprehensive program to ensure compliance of research and development activities conducted by VAPHS. Provides executive oversight for the development, evaluation, and implementation of educational programs.

Duties

Program Management and Administration Human Research Protection Program: The RCO is responsible for reviewing the credentialing, privileging, and training of all investigators and staff to ensure that all personnel conduct research within their scope of practice. Reviews all research projects involving human subjects, including a review of informed consent documents, research protocols, safety and quality measures established to protect research personnel as well as veteran and non-veteran subjects. Conducts quality assurance reviews of HRPP to identify potential noncompliance trends and develop plans for remediation. Liaison with outside entities concerning compliance issues in accordance with the "Common Rule" 45 CFR 46 and other regulations and policies of the Department of Veterans Affairs, Department of Health and Human Services (DHHS), National Institutes of Health (NIH), Food and Drug Administration (FDA), State of Pennsylvania, and VAPHS. Animal Studies: Reviews Institutional Animal Care and Use Committee activities, records to ensure compliance with VHA, State, national and other regulatory body requirements. Communicates with the Animal Research Facility Supervisor and Veterinarians in relation to monitoring animal health and adherence to Standard Operating Procedures Conducts quality assurance reviews to identify potential noncompliance trends and develop plans for remediation. Participates in walk-through inspections to assist in identifying potential weaknesses and noncompliance situations Primary advisor regarding policy matters, process issues and procedure requirements for conducting research involving animals. Laboratory Safety and Biosafety: Reviews Institutional Biosafety Committee/Safety Research Subcommittee activities, records (including databases and meeting minutes) to ensure compliance with VHA, State, NIH, national and other regulatory body requirements as needed. Assures safety and compliance by conducting inspections and other monitoring activities Advise and assist management in investigations following accidents and incidents Assist in the preparation of standard operating procedures for the safe use, storage, transport, and disposal of biohazards. Conducts quality assurance reviews to identify potential noncompliance trends and develop plans for remediation. Conflict of Interest/Research Integrity Ensures that any Conflict of Interest that an Investigator may have in connection with a Research Project is fully disclosed, reviewed in accordance with established procedures, and satisfactorily resolved before the Research Project is initiated, regardless of funding. Develops processes, procedures and training modules related to research matters pertaining to Conflict of Interest. Analytics/Audits, Monitoring and Reporting Evaluates compliance with federal, state and VA requirements for the conduct of research, which may include requirements in one of more of the following areas: the protection of human research subjects, laboratory animal welfare, and research safety and security. Reports findings and recommendations of review, audit and/or investigation activities to the Medial Center Director, Associate Chief of Staff (ACOS) for R&D, and R&D Committee. Analyzes and evaluates, on a quantitative or qualitative basis, the effectiveness of programs and operations in meeting established compliance goals and objectives. Prepares program status reports for review at all levels. Collaboration and Education Participates in the development and delivery of education and training for research employees regarding compliance requirements. Directly involved with the development and implementation of effective educational programs that promote responsible conduct and integrity in scientific research. Collaborates with the Information Security Officer and the Privacy Officer in matters related to protection of sensitive and non-sensitive information. . Serves as a panelist for the Office of Research Oversight for the education of New Research Compliance Officers (RCO) Workshop. Serves as a mentor to multiple new RCOs at the Direction of ORO. Mentors and Trains new RCOs stationed at other VHA facilities. Performs other duties as assigned. Work Schedule: Monday - Friday 8am - 4:30pm Compressed/Flexible: not authorized Telework: 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. Virtual: This is not a virtual position. Position Description/PD#: Program Specialist - Research Compliance Officer/PD019330 Relocation or Recruitment Incentives: authorized 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, 11/24/2023. 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: .analyze and evaluate on a quantitative or qualitative basis, the effectiveness of programs and operations in meeting compliance goals, develop procedures and systems for establishing operating, and assessing the effectiveness of compliance control systems, monitor audits, inspections or management of internal control reviews, develop and implement educational programs, identify key policy issues and priorities, review credentialing, privileging and training of investigators and staff and program management for HR Protection Program, Animal Studies, Lab Safety and Biosafety, Conflict of Interest/Research Integrity. You will be rated on the following Competencies for this position: Analytical ThinkingAuditingComplianceResearch 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: Physical Demands Typically, the employee sits comfortably to do the work. However, there may be some walking; standing; bending; carrying of light items, such as papers, books, or records; or driving an automobile. 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

There is no educational substitution at this grade level.

Contacts

• Address Pittsburgh VA Medical Center 1010 Delafield Road Pittsburgh, PA 15215 US
• Name: Christene Ammoscato
• Phone: (570) 824-3521 X24536
• Email: [email protected]