This position serves as Health Science Specialist - Research Study Coordinator within the Research and Development (R&D) Service located at the Veterans Healthcare System in West Palm Beach, FL. 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.
Basic Education Requirement: Bachelor's or graduate/higher level degree with a 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. NOTE: Transcripts required with your application materials. Education cannot be credited without documentation. To qualify at the GS-9 level, applicant(s) must meet one of the following minimum qualification requirements in addition to the basic education requirement above. Specialized Experience: Requires one full year of specialized 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-7) in the normal line of progression for the occupation in the organization. Specialized experience is applying knowledge of the activities required in conducting clinical research, human subjects' protection, and regulatory and policy compliance, and includes: Coordinating and monitoring progress of the day-to-day clinical research projects and programs; Recruiting, enrolling and interviewing study participants and obtaining informed consent; and Utilizing software used for data collection, and regulatory compliance to extract, organize, track, and analyze data, produce letters, memorandums, and prepare a variety of documents and reports. -OR- Education: Successfully completed 2 years of progressively higher level graduate education leading to a master's degree or master's or equivalent graduate degree with a major in the medical field, health sciences or allied sciences. Such education must demonstrate the knowledge, skills, and abilities necessary to do the work of this position. NOTE: Transcripts required with your application materials. Education cannot be credited without documentation. -OR- Combination: Equivalent 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 one year (i.e., excess of 18 semester hours) is creditable to combine with specialized experience. The education portion must include graduate courses that demonstrate the knowledge, skills, and abilities necessary to do to the work of this position. Physical Requirements and Work Environment: The work is primarily sedentary with occasional walking, standing, and handling and carrying items such as paper and books. There may be occasional 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. You will be rated on the following Competencies as part of the assessment questionnaire for this position: Clinical Data Collection/Documentation Database Administration Project Management Research IMPORTANT: A full year of work is considered to be 35-40 hours of work per week. All experience listed on your resume must include the month and year start/end dates. 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. 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; religious; 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. 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/.
***THIS IS NOT A VIRTUAL POSITION, YOU MUST LIVE WITHIN OR BE WILLING TO RELOCATE WITHIN A COMMUTABLE DISTANCE OF THE DUTY LOCATION*** This position involves a multi-grade career ladder. The major duties listed below represent the full performance level of GS-11. At the GS-9 grade level, you will perform assignments of a more limited scope and with less independence. You will progressively acquire the background necessary to perform at the full performance level of GS-11. Promotion is at the discretion of the supervisor and is contingent upon satisfactory performance, availability of higher level work, and availability of funds. 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: Full-Time, Monday-Friday, 8:00am - 4:30pm Telework: This position may be authorized for telework. Telework eligibility will be discussed during the interview process. Recruitment & Relocation Incentives: Not authorized Critical Skills Incentive (CSI): Not Approved