Health Science Specialist - Research Study Coordinator

Summary This position serves as Health Science Specialist - Research Study Coordinator within the Research and Development (R&D) Service. 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. Qualifications All applicants must meet the following 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 at the time the degree was obtained. Transcripts (unofficial or official) must be submitted with your application materials. Education cannot be credited without documentation. To qualify for the GS-11 level you must meet one of the following: Specialized Experience: You must possess at least one full year of specialized experience that equipped you with the knowledge, skills, and abilities to successfully perform the duties of a 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, 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. 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. Substitution of Education for Experience: You must possess three years of progressively higher-level graduate education leading to a Ph.D. degree or equivalent doctoral degree with a major in a field appropriate to the work of this position. This education must have been obtained in an accredited college or university. One year of full-time graduate education is considered to be the number of credit hours that the school determined to represent one year of full-time study. If that number cannot be obtained from the school, 18 semester hours will be considered an academic year of graduate study. Part-time graduate education is creditable in accordance with its relationship to a year of full-time study at the school attended. Transcripts must be submitted with application materials. Education cannot be credited without documentation. Combination of Education and Experience: You must possess an equivalent combination of successfully completed graduate level education and specialized experience to meet total experience requirements. The education portion must include graduate courses that demonstrate the knowledge, skills, and abilities necessary to do the work of this position. Experience must be fully documented on your resume and must include job title, duties, month and year start/end dates, and hours worked per week. A full year of work is considered to be 35-40 hours of work per week. Transcripts must be submitted with application materials. Education cannot be credited without documentation. For more information on these qualification standards, please visit the United States Office of Personnel Management's website at Duties This is not a virtual position - you must live within or be willing to relocate within a commutable distance of the duty location. This is a term appointment (not-to-exceed 1 year and 1 day - may be extended up to 4 years). Term appointments are non-status - nonpermanent appointments of limited duration (more than 1 year but not more than 4). Term employees are eligible to earn leave and generally have the same benefits as permanent employees including health and life insurance - within-grade increases and Federal Employees Retirement System and Thrift Savings Plan coverage. Term appointments may be extended without further competition (up to the 4-year maximum). The appointment to a term position does not confer eligibility for promotion or reassignment to other positions or the ability to be non-competitively converted to permanent employment. 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 if 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; Critical Skills Incentive (CSI): Not approved. #J-18808-Ljbffr 340B Health