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.
Starting at $87,208 Per Year (GS 12)