Summary This position is located at the West Haven Cooperative Studies Program Coordinating Center (CSPCC) at the VA Connecticut Healthcare System. The Cooperative Studies Program (CSP) is a national clinical trials program providing collaboration for research design, statistical analysis, data management, regulatory, technical, education, and administrative coordination. This is a developmental GS-09 level position, full performance-level is GS-11. Responsibilities Major Duties: Responsible for managing all administrative aspects of the trial/study and is the primary interface between the sponsor and investigative institutions (sites). This includes managing the trial timeline, evaluating study activities, ensuring necessary resources and personnel are available, training study personnel, managing and leading study meetings, and maintaining clinical trial documentation. Reports trial issues requiring sponsor guidance. This includes deviations at a specific site, non-compliance with federal regulations or the CSP Coordinating Center, issues of patient safety and confidentiality, results of other trials that warrant attention and consideration with respect to study conduct, etc. Monitors regulatory adherence of sites and requests documentation for sponsor site files. Provides advice and recommendations to problem sites to resolve administrative, financial, and regulatory problems. Problems include change in personnel, poor enrollment, non-compliance with protocol, and regulatory requirements, poor trial/patient management, and serious issues related to patient safety. Ensures the clinical trials are conducted in compliance with regulations and guidance established by the VA and the Food and Drug Administration (FDA). Responsibilities include following CSP standard operating procedures and guidance, as well as communicating procedures to study leadership and team. Manages and makes decisions related to the study/clinical trial budget. Reviews yearly fiscal budget support requests from sites ensuring adherence to the protocol. Monitors expenditures of study funds and staffing levels, prepares summaries and reports as required, and projects anticipated future year expenditures. Communicates with internal and external customers regarding problem sites and acts as a liaison regarding various documents and FDA requirements. 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: 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. Telework eligibility will be discussed during the interview process. Virtual: This is not a virtual position. Position Description/PD#: Program Specialist/PD00309A and PD00310A Relocation/Recruitment Incentives: Not Authorized. Critical Skills Incentive (CSI): Not Approved. Permanent Change of Station (PCS): Not Authorized. 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, 09/26/2024. 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-09 position you must have served 52 weeks at the GS-07. 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 For the GS-09 level: To qualify, applicants must have one year of specialized experience equivalent to at least the next lower grade (GS-07) in the normal line of progression for the occupation in the organization." Specialized experience is defined as work that involves (1) interpreting Federal, State laws, rules, and regulations relative to compliance and the conduct of investigative studies, (2) applying analytical and evaluative principles to resolve issues and accomplish program goals for a clinical, medical, and/or research department/organization, (3) creating, maintaining, and disseminating electronic information and documents/files; effectively communicates, orally and in writing, between agencies and across organizational levels to coordinate research needs and deliver requested information. OR, Education. A master's or equivalent graduate degree, or 2 full years of progressively higher level graduate education leading to such a degree, or LL.B. or J.D. related to the work of this position (TRANSCRIPTS REQUIRED). OR, Combination. Equivalent combinations of education and experience are qualifying for all grade levels for which both education and experience are acceptable. Specialized Experience For the GS-11 level: To qualify, applicants 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." Specialized experience is defined as work that involves (1) knowledge applying Federal, State laws, rules, and regulations relative to compliance and the conduct of investigative studies, (2) interpreting and analyzing data using discretion to implement a wide range of research policies and procedures, (3) preparing and conducting study presentations, trainings, and briefings (4) reviewing and preparing trial budget, and (5) assisting in developing action plans to resolve problems or improve efficiency, and implementation of new methods. OR, Education. 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. Equivalent combinations of education and experience are qualifying for all grade levels for which both education and experience are acceptable. Please select the response below which best describes your qualifications for this position at the GS-11 grade level. You will be rated on the following Competencies for this position: Administration and Management Education and Training Contracting/Procurement Financial Management Knowledge Management 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: https://sites.ed.gov/international/recognition-of-foreign-qualifications/. 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. This job opportunity announcement may be used to fill additional vacancies. Pursuant to VHA Directive 1193.01, VHA health care personnel (HCP) are required to be fully vaccinated against COVID-19 subject to such accommodations as required by law (i.e., medical, religious or pregnancy). VHA HCPs do not include remote workers who only infrequently enter VHA locations. If selected, you will be required to be fully vaccinated against COVID-19 and submit documentation of proof of vaccination before your start date. The agency will provide additional information regarding what information or documentation will be needed and how you can request a legally required accommodation from this requirement using the reasonable accommodation process. If you are unable to apply online or need an alternate method to submit documents, please reach out to the Agency Contact listed in this Job Opportunity Announcement. 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.