Program Specialist

Summary This position is in the Cooperative Studies Program Coordinating Center (CSPCC) of the VA Medical Center in Perry Point, VA. The Program Specialist manages all of the administrative aspects of nation-wide, multi-site, human subject clinical research trials. Duties ***THIS IS NOT A VIRTUAL POSITION, YOU MUST LIVE WITHIN OR BE WILLING TO RELOCATE WITHIN A COMMUTABLE DISTANCE OF THE DUTY LOCATION*** Managing all administrative aspects of the trial/study and is the primary interface between the sponsor and investigative institutions (sites); Managing trial timelines and evaluating study activities to ensure the necessary resources and personnel are available to successfully complete the trial within the timeline; Managing the trial budget and making decisions related to the budget; Projecting and reporting anticipated yearly expenditures; Ensuring that CSP and study sites are complying with VA and FDA clinical trials regulations and guidance; Evaluating data from determine if sites are following study guidance and, if required, leads interventions to bring site into compliance; Ensuring study personnel are trained in administrative aspects of the clinical trial, regulatory requirements, and patient safety reporting; Managing and leading study meetings; Overseeing the establishment and maintenance of clinical trial documentation as required by the VA and FDA regulations and guidance; Reporting and requesting the approval of updates to the study literature, protocol, and informed consent forms from the Institutional Review Board (IRB) and the FDA; Preparing study expense reports focusing on study progress and patient safety information; Performing related duties as required. Work Schedule: Monday through Friday, 8:00am - 4:30pm. A compressed schedule is available (to be discussed during interview). Recruitment & Relocation Incentives: Not authorized. Requirements Conditions of employment You must be a U.S. Citizen to apply for this job To be considered for this position, you must complete all required steps in the process. In addition to the application and questionnaire, this position requires an online assessment. The online assessment measures critical general competencies required to perform the job. Selective Service Registration is required for males born after 12/31/1959 Physical Requirements: The work required does not inherently include any physical requirements essential for successful job performance that could not otherwise be performed with accommodation or workplace adjustment. A pre-placement physical examination is not required. Subject to background/security investigation Selected applicants will be required to complete an online onboarding process. Acceptable form(s) of identification will be required to complete pre-employment requirements (https://www.uscis.gov/i-9-central/form-i-9-acceptable-documents). Effective May 7, 2025, driver's licenses or state-issued dentification cards that are not REAL ID compliant cannot be utilized as an acceptable form of identification for employment. Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP) - See "Required Documents" below for details. As a condition of employment for accepting this position, you will be required to serve a 1-year probationary period during which we will evaluate your fitness and whether your continued employment advances the public interest. In determining if your employment advances the public interest, we may consider: your performance and conduct; the needs and interests of the agency; whether your continued employment would advance organizational goals of the agency or the Government; and whether your continued employment would advance the efficiency of the Federal service. Upon completion of your probationary, your employment will be terminated unless you receive certification, in writing, that your continued employment advances the public interest. Qualifications MINIMUM QUALIFICATIONS GS-09: One year of specialized experience that equipped you with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled. To be creditable, specialized experience must have been equivalent to at least the GS-07 grade level. Examples of specialized experience include: using a wide range of concepts, principles, and practices to support clinical trials; developing policies, procedures, and criteria for the administration of health science research; collecting data and monitoring protocols for difficult clinical studies; and interpreting results, evaluating programs, and recommending improvements. This experience must be detailed in your resume to receive credit. ~OR~ A master's degree, equivalent graduate degree, 2 full years of progressively higher level graduate education leading to such a degree, or an LL.B. or J.D. in a related field. One year of full-time graduate education is the number of credit hours that the school attended has determined to represent 1 year of full-time study. If that information cannot be obtained from the school, 18 semester hours should be considered as satisfying the 1 year of full-time study requirement. Part-time graduate education is creditable in accordance with its relationship to a year of full-time study at the school attended. Transcripts required. ~OR~ An equivalent combination of specialized experience and graduate education as described that demonstrates your ability to perform the duties of the position. Experience must be detailed in your resume and transcripts required. MINIMUM QUALIFICATIONS GS-11: One year of specialized experience that equipped you with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled. To be creditable, specialized experience must have been equivalent to at least the GS-09 grade level. Examples of specialized experience include: using a wide range of concepts, principles, and practices to support clinical trials; developing policies, procedures, and criteria for the administration of health science research; collecting data and monitoring protocols for difficult clinical studies; developing new methods, approaches, or procedures in the coordination of research projects or clinical studies; and interpreting results, evaluating programs, and recommending improvements. This experience must be detailed in your resume to receive credit. ~OR~ A Ph.D., equivalent doctoral degree, 3 full years of progressively higher level graduate education leading to such a degree, or an LL.M. in a related field. One year of full-time graduate education is the number of credit hours that the school attended has determined to represent 1 year of full-time study. If that information cannot be obtained from the school, 18 semester hours should be considered as satisfying the 1 year of full-time study requirement. Part-time graduate education is creditable in accordance with its relationship to a year of full-time study at the school attended. Transcripts required. ~OR~ An equivalent combination of specialized experience and graduate education as described that demonstrates your ability to perform the duties of the position. Experience must be detailed in your resume and transcripts 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 IMPORTANT: 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/. Additional information Reasonable Accommodation (RA) Requests: If you believe you have a disability (i.e., physical or mental), covered by the Rehabilitation Act of 1973 as amended that would interfere with completing the USA Hire Competency Based Assessments, you will be granted the opportunity to request a RA in your online application. Requests for RA for the USA Hire Competency Based Assessments and appropriate supporting documentation for RA must be received prior to starting the USA Hire Competency Based Assessments. Decisions on requests for RA are made on a case-by-case basis. If you meet the minimum qualifications of the position, after notification of the adjudication of your request, you will receive an email invitation to complete the USA Hire Competency Based Assessments, based on your adjudication decision. You must complete all assessments within 48 hours of receiving the URL to access the USA Hire Competency Based Assessments if you received the link after the close of the announcement. To determine if you need a RA, please review the Procedures for Requesting a Reasonable Accommodation for Online Assessments. Receiving Service Credit for 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. This job opportunity announcement may be used to fill additional vacancies. Under the Fair Chance to Compete Act, the Department of Veterans Affairs prohibits requesting an applicant's criminal history prior to accepting a tentative job offer. For more information about the Act and the complaint process, visit Human Resources and Administration/Operations, Security, and Preparedness (HRA/OSP) at The Fair Chance Act. The Interagency Career Transition Assistance Plan (ICTAP) and Career Transition Assistance Plan (CTAP) provide eligible displaced Federal competitive service employees with selection priority over other candidates for competitive service vacancies. To be qualified you must submit appropriate documentation and be found well-qualified (have a final rating of 80 or more before any Veterans preference points) for this vacancy. 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/. Note: Per "Executive Order 14251: Exclusions from Federal Labor-Management Relations Programs", this position is no longer eligible for bargaining unit participation. Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution. Benefits A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits. Review our benefits Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.