Summary Thank you for your interest in applying to this Health Science Specialist vacancy. This position is located in the Cancer Center under Hematology/Oncology Section in Medicine Service for the West Haven VA Medical Center and is at the full performance level of GS-12. The Cancer Center and affiliated investigators conduct multiple cancer-related clinical studies that make novel therapies available to patients with cancer and help advance the field of cancer medicine. Responsibilities The duties of this position include but are not limited to the following : Plan, develop, complete and submit documentation for initial and continuing review to the local research office. Prepare and submit regulatory documents to different agencies within specified timeline. Collect baseline/screening data, enter required data into study-specific electronic data capture (EDC) system and randomization system (if applicable). Develop policies, procedures, and criteria for the administration of the clinical studies program, and to implement data collection and monitoring protocols for complex clinical studies. Analyze processes and documentation to ensure compliance with regulatory, privacy, and information security requirements for each individual clinical trial. Assist local ACOS-R, R&D service AO, and Research Budget Analyst in expensing and allocating research funds granted to a clinical research program. Manage subject compensation, maintain compensation records, and prepare invoices for reimbursement, as required by individual clinical trial budgets. Monitor clinical trial progress and timelines. Establish and manage an electronic project tracking system, to assess and improve study timelines, from initiation to completion. Organize and maintain all required study specific documents, including regulatory and source documentation. Track required training and certifications for study personnel, and assure they are maintained and up to date. Initiate, carry out, and complete National Cancer Institute ( NCI ) sponsored, investigator initiated, and pharmaceutical sponsored clinical trials in accordance with the study protocols. Explain and educate potential research subjects regarding the nature and purpose of clinical research in general and specific clinical trials for which they are eligible. Conduct research visits, as required by study protocols. Prepare and participate in audits and monitor visits, for compliance with the sponsors and cooperative groups. Collect, prepare according to study protocol, and ship samples (e.g. urine, blood, bone marrow, tumor) to study sponsor, as required by specific clinical trials, using methods approved by local and/or national information security officers. Assess for serious and non-serious adverse events and communicate them in the required timeframe with the study sponsor and IRB using established documentation. Assist in hiring, writing Position Descriptions, performance-based interviewing and selection of candidates in conjunction with the Principal Investigators. Promotion Potential: This position is at the full performance level of this occupation. Work Schedule: Full Time 8:00am - 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. Telework eligibility will be discussed during the interview process. Virtual: This is not a virtual position. Position Description/PD#: Health Science Specialist/PD038080 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, 11/06/2024. 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-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. This occupation has an Individual Occupational Requirement (IOR) for all grades : The IOR is the basic requirement and must be met in addition to the Grade Determining requirements. The IOR for this occupation is Education: Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained. You must qualify based on your experience and/or education as described below: Grade Determination: GS 12 Health Science Specialist : Education or Specialized Experience or a combination of both as explained below. Specialized Experience: Experience that equipped the applicant 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 next lower grade level GS-11 in the normal line of progression for the occupation in the organization. Examples of Specialized Experience include but are not limited to : managing a clinical research program and providing a high level of assistance to the Principal Investigators of the clinical trials; assessing feasibility of research studies, study initiation, subject recruitment and enrollment, data collection and review, sample collection, preparation, and shipping, regulatory tasks, financial oversight, screening for clinical trials and program building at the VISN and national level. 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, Combination: Combination of Graduate Education and Professional Experience: Combinations of successfully completed graduate level education and specialized experience may be used to meet total experience requirements. Only graduate level education in excess of a Master's or equivalent graduate degree may be combined with experience. You will be rated on the following Competencies for this position: Administration and Management Clinical Data Collection/Documentation Information Technology Research and Development Project Management Research Preferred Experience: Experience in cancer clinical trials, especially NCTN ( NCI's National Clinical Trials Network ) clinical trials. 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, but does require walking, standing, and carrying light to moderately heavy packages or boxes (e.g. study documentation in binders, samples for shipping). Some travel will be required. Work Environment: The work is performed in a research and clinical setting. There are special considerations and training related to handling and processing blood or bodily fluids, which may be required in certain clinical trial protocols. Personal protective equipment (lab gown/coat, gloves) may be required based on the task. 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. do not submit a diploma as it does not provide the important details of your education such as courses taken and GPA . 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.