Program Specialist

Employer
USAJobs
Location
Salem, Virginia
Posted
Jun 21, 2022
Closes
Jun 24, 2022
Function
Program Manager
Hours
Full Time
Duties

Duties
Oversees the review process of all research protocols which encompasses all research committees reviewing animal, laboratory, and human research, i.e. the Research and Development (R&D) Committee, Institutional Review Board (IRB), Subcommittee on Research Safety (SRS), Central Institutional Review Board (CIRB), and Commercial IRBs.

Educates research committee Chairpersons, research committee members, research investigators, research coordinators, and other research staff on all Research committee regulatory policies and procedures.

Serves a primary subject matter expert to Research Investigators, Research Coordinators, Research Service Administrative Staff, and Committee Members for Research and Development (R&D) Committee and subcommittees for the following specialized systems within the R&D Service: VA Innovation and Research Review System (VAIRRS/IRBNet), for all research protocol submissions

Ensures that all the respective committee actions and procedures are within the scope of all applicable local, Office of Research & Development (ORD), Office of Research Oversight (ORO), and Food and Drug Administration (FDA) regulations

Drafts memoranda to Investigators and Committee/Subcommittees members relating to required determinations, outlines deficiencies and specifies dates for resubmission.

Ensures compliance issues are remediated through intercession and supportive assistance; negotiates solutions regarding Committee/Board recommendations that are disputed by the research investigators or coordinators.

Validates investigational drug device numbers for clinical investigations.

Administers E-Promise and ERA Commons within the Service

Handles communication with the investigators, private research agencies/foundations, other governmental research organizations (NIH, etc.) commercial research funding sources and industry.

Manages office for Human Research Protections (OHRP) Federal Wide Assurance (FWA) submissions, registration and roster updates wit multiple oversight entities.

Contributes to the development and updates to forms and SOPs related to the Committee/Subcommittees processes and policy.

Performs other related duties as assigned.

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-Friday, 8:00am--4:30pm
Telework: No
Virtual: This is not a virtual position.
Position Description/PD#: Program Specialist/PD02300-0
Financial Disclosure Report: Not required

Requirements

Conditions of Employment


  • You must be a U.S. Citizen to apply for this job
  • Selective Service Registration is required for males born after 12/31/1959
  • You may be required to serve a probationary period
  • Subject to background/security investigation
  • Selected applicants will be required to complete an online onboarding process
  • Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP)
  • Participation in the Coronavirus Disease 2019 (COVID-19) vaccination program is a requirement for all Veterans Health Administration Health Care Personnel (HCP) - See "Additional Information" below for details.


Qualifications

To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 06/23/2022.

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-9 position you must have served 52 weeks at the GS-7.
For a GS-11 position you must have served 52 weeks at the GS-9.

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:
FOR GS-9:
  • Specialized Experience: You must have one year of specialized experience equivalent to at least the next lower grade GS-7 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 of and skill in applying Federal, State and VA laws, rules and regulations relative to compliance and the conduct of investigative studies involving, animal study research, research safety and security, and research information security; including but not limited to FDA, USDA, Department of Health and Human Services, Office of Human Research Protection, Office of Research and Development and the Office of Research Oversight. Knowledge of applying pertinent laws, regulations, policies and precedents which affect the use of program and related support resources in the area studied.. OR,
  • Education: Applicants may substitute education for the required experience. To qualify based on education for this grade level you must have a masters or equivalent degree OR Two (2) full years of graduate education. 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 graduate education.
FOR GS-11:
  • Specialized Experience: You must have one year of specialized experience equivalent to at least the next lower grade GS-9 in the normal line of progression for the occupation in the organization. Examples of specialized experience would typically include, but are not limited to: Thorough knowledge of and skill in applying Federal, State and VA laws, rules and regulations relative to compliance and the conduct of investigative studies involving, human subjects research, animal study research, research safety and security, and research information security; including but not limited to FDA, USDA, Department of Health and Human Services, Office of Human Research Protection, Office of Research and Development and the Office of Research Oversight. Knowledge of and skill in applying pertinent laws, regulations, policies and precedents which affect the use of program and related support resources in the area studied. Thorough knowledge of ethical principles, laws, regulations and policies governing the review and approval of human subjects research, laboratory research and animal research. Uses the knowledge to provide advice and consultation to Institutional Review Board (IRB), Sub-Committee on Research Safety(SRS) and Research & Development (R&D) chairs, members and staff, and to educate the investigative community of local and external policies and procedures with regards to research with human, laboratory, animal and safety/security components. 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,
  • Combination: Applicants may also combine education and experience to qualify at this level. You must have an combination of specialized experience and education above Ph.D. level NOTE: Must have education above the 1st year and a half above the Ph.D. level. TRANSCRIPT(S) MUST BE SUBMITTED IF EDUCATION IS BEING USED TO QUALIFY.
You will be rated on the following Competencies for this position:
  • Analytical Reasoning
  • Customer Service
  • Organizational Awareness
  • Planning and Evaluating


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

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: http://www.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html .

Additional information

Receiving Service Credit or Earning Annual (Vacation) Leave: Federal Employees earn annual leave at a rate (4, 6 or 8 hours per pay period) which is based on the number of years they have served as a Federal employee. Selected applicants may qualify for credit toward annual leave accrual, based on prior work experience or military service experience. This credited service can be used in determining the rate at which they earn annual leave. Such credit must be requested and approved prior to the appointment date and is not guaranteed.

Special Employment Consideration: VA encourages persons with disabilities to apply, including those eligible for hiring under 5 CFR 213.3102(u), Schedule A, Appointment of persons with disabilities [i.e., intellectual disabilities, severe physical disabilities, or psychiatric disabilities], and/or Disabled veterans with a compensable service-connected disability of 30% or more. Contact the Agency Contact for information on how to apply under this appointment authority via the Selective Placement Coordinator.

The Interagency Career Transition Assistance Plan (ICTAP) and Career Transition Assistance Plan (CTAP) provide eligible displaced Federal/VA competitive service employees with selection priority over other candidates for competitive service vacancies. To be qualified you must submit appropriate documentation (a copy of the agency notice, your most recent performance rating, and your most recent SF-50 noting current position, grade level, and duty location) and be found well-qualified for this vacancy. To be well-qualified : applicants must possess experience that exceeds the minimum qualifications of the position including all selective factors, and who are proficient in most of the required competencies of the job. Information about ICTAP and CTAP eligibility is on OPM's Career Transition Resources website at http://www.opm.gov/policy-data-oversight/workforce-restructuring/employee-guide-to-career-transition/ .

This job opportunity announcement may be used to fill additional vacancies.

To ensure compliance with an applicable preliminary nationwide injunction, which may be supplemented, modified, or vacated, depending on the course of ongoing litigation, the Federal Government will take no action to implement or enforce the COVID-19 vaccination requirement pursuant to Executive Order 14043 on Requiring Coronavirus Disease 2019 Vaccination for Federal Employees. Therefore, to the extent a VA job announcement includes language requiring applicants to be fully vaccinated against COVID-19 pursuant to Executive Order 14043, that requirement does not currently apply to this Job Announcement. VA may request information regarding your vaccination status, if selected, for the purposes of implementing other workplace safety protocols, such as masking, physical distancing, testing, travel, and quarantine.

If you are unable to apply online or need to fax a document you do not have in electronic form, view the following link for information regarding an Alternate Application .