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. To qualify for this position, you must meet the following requirements: SPECIALIZED EXPERIENCE: One (1) full year of specialized experience equivalent to at least the next lower grade level (GS-9) in the Federal Service, that is directly related to the work of the position and has equipped you with the particular knowledge, skills and abilities to successfully perform the duties as a Health Science Specialist - Research Study Coordinator. Qualifying 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; and Conducting telephone and in-person interviews of human study subjects using various methods of data collection. OR EDUCATION: I successfully completed a Master's or equivalent graduate degree, in a related field of the position to be filled. Education at the graduate level must have been obtained in an accredited college or university and must demonstrate the knowledge, skills, and abilities necessary to do the work of this position. NOTE: Transcripts must be submitted with your application materials. Education cannot be credited without documentation. OR COMBINATION OF EXPERIENCE AND EDUCATION: Equivalent combination of successfully completed graduate level education (beyond 2 years of progressively higher level graduate education leading to a master's degree or master's or equivalent graduate degree) and specialized experience as described above, to meet the total experience requirements. The education portion must include graduate courses that demonstrate the knowledge, skills, and abilities necessary to do to the work of this position. This education must have been obtained in an accredited college or university. NOTE: Transcripts must be submitted with your application materials. Education cannot be credited without documentation. Experience must be clearly indicated in your resume. You will be rated on the following Competencies as part of the assessment questionnaire for this position: Communications Critical Thinking Manages and Organizes Information 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. Physical Requirements: The work is primarily sedentary with occasional walking, standing, handling and carrying items such as papers and books. There may be occasional need to assist study participants with mobility to study location(s). Some travel will 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/. ["***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, 7:00am - 3:30pm Recruitment & Relocation Incentives: Not authorized Critical Skills Incentive (CSI): Not approved 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."]
The Veterans Health Administration (VHA) is the largest integrated health care system in the United States, providing care at 1,321 health care facilities, including 172 VA Medical Centers and 1,138 outpatient sites of care of varying complexity (VHA outpatient clinics) to over 9 million Veterans enrolled in the VA health care program. VHA Medical Centers provide a wide range of services including traditional hospital-based services such as surgery, critical care, mental health, orthopedics, pharmacy, radiology and physical therapy. In addition, most of our medical centers offer additional medical and surgical specialty services including audiology & speech pathology, dermatology, dental, geriatrics, neurology, oncology, podiatry, prosthetics, urology, and vision care. Some medical centers also offer advanced services such as organ transplants and plastic surgery.