Summary This position serves as Health Science Specialist - Research Study Coordinator within the Research and Development (R&D) Service, VA Medical Center, Syracuse, NY. The VA Research Program strives to promote Veteran-centered care to improve patient experiences and outcomes across VA healthcare and community settings, and to advance value-driven care by providing Veterans the highest quality care at the lowest financial burden. Responsibilities THIS IS NOT A VIRTUAL POSITION, YOU MUST LIVE WITHIN OR BE WILLING TO RELOCATE WITHIN A COMMUTABLE DISTANCE OF THE DUTY LOCATION The Research Study Coordinator manages clinical tests, collects data, and recruits and manages subjects for clinical trials while providing high-level technical support of projects in a comprehensive research setting. Duties and responsibilities include but are not limited to: Manages Clinical Tests and Collects Data Collects and analyzes data, educates, and interacts with study participants and leadership. Provides detailed and summary information and recommendations for further actions based on the data analysis. Manages implementation, control and reporting on clinical tests. Implements data collection and monitors protocols for difficult clinical research studies. Administers or monitors administration of tests and measurements required by project design. Records data from samples and specimens to ensure that all tracking data is organized and is monitored during the progress of the study. Identifies test results and trends requiring further analysis. Maintains all study and regulatory records. Prepares project and statistical reports for review process. Recruits and Manages Candidates for Clinical Trials Oversees, screens, and evaluates recruitment of candidates for clinical research studies via telephone and/or in person. Uses objective rating techniques to identify potential candidates for participation in study where project design is complex. Performs informed consent process throughout the study and continuously educates participants on study processes and procedures. Performs day-to-day activities related to conducting and overseeing participant interviews and follow-up. Coordinates study participant randomization to treatment, works closely with the Research Pharmacy on study drug provision. Research Project Support Assists supervisor with managing the routine, day-to-day activities, and administration of the project. Plans, develops, completes, and submits on time all required documentation/ paperwork/forms for initial and continuing human subject's review. Analyzes processes and documentation to ensure compliance with all technical, regulatory requirements, and information safety regulations. Conducts quality assurance evaluations for project data and clinical research instruments, as applicable. Establishes and monitors remediation plans to correct deficiencies. Drafts detailed and summary reports for presentation at meetings and conferences and for publication in peer reviewed journals. Compiles and produces educational and training materials; determines contents needed for training binders and tools. Work Schedule: Monday - Friday, 8:00am - 4:30pm. 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 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 Basic Education Requirement: 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 (external link) at the time the degree was obtained. A transcript is required at the time of application. To qualify at the GS-11 level you must also meet one of the following minimum qualification requirements in addition to the basic education requirement above. Specialized Experience: You must possess at least one (1) full year of specialized experience that equipped you with the knowledge, skills, and abilities to successfully perform the duties of a Health Science Specialist - Research Study Coordinator and provided you with knowledge of the full scope of activities required in conducting single and/or multi-site clinical research including study/project management, human subjects' protection, and regulatory and policy compliance. To be creditable, specialized experience must have been equivalent to at least the next lower grade level (GS-9) in the normal line of progression for the occupation in the organization. Specialized experience includes: Performing a variety of tasks related to the conducting of the clinical/healthcare related research such as participant recruitment and enrollment, protocol execution, data reporting and management, and regulatory compliance Screening and evaluating the recruitment of candidates for clinical research studies Analyzing processes and documentation to ensure compliance with all technical, regulatory requirements, and information safety regulations Utilizing software used for project management, data collection, and regulatory compliance to extract, organize, track, and analyze data, produce letters and memorandums, and prepare a variety of documents and presentations Conducting telephone and in-person interviews of human study subjects using various methods of data collection -OR- Education (Transcripts Required): You may substitute the specialized experience with education if you possess successful completion of three (3) years of progressively higher level graduate education leading to a Ph.D. degree or Ph.D. or equivalent doctoral degree with a major in a field appropriate to the work of this position that provided the knowledge, skills, and abilities necessary to do the work is qualifying at the GS-11 grade level. Such education must demonstrate the knowledge, skills, and abilities necessary to do the work of this. NOTE: Copies of transcripts must be submitted with your application materials. Education cannot be credited without documentation. -OR- Combination (Transcripts Required): A combination of successfully completed graduate education and specialized experience may be used to meet total qualification requirements. The education portion must include graduate courses that demonstrate the knowledge, skills, and abilities necessary to do to the work of this position. NOTE: Copies of transcripts must be submitted with your application materials. Education cannot be credited without documentation. Physical Requirements: The work is primarily sedentary with occasional walking, standing, and handling and carrying items such as paper and books. There may be occasion needs to assist study participants with mobility to study location(s). Some travel will be required. The work is performed in a research setting requiring no special considerations beyond accepted standards of safety. The work area is adequately lighted, heated, and ventilated. There may be occasional exposure to moderate risks or during program/project and country visits. 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.
