This position is located in the Research and Development Service at VA Southeast Louisiana Health Care System - New Orleans VA Medical Center in New Orleans, LA. The Health System Specialist serves as a Research Study Coordinator and is fully responsible for ensuring database development, coordination, and technical management in a comprehensive research setting and providing day-to-day data management and site support for the VA Research Program. Basic Requirement: The following are basic requirements for appointment as a Health System Specialist in the Veterans Health Administration (VHA), which all applicants must met. Basic 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. (UNOFFICIAL TRANSCRIPT REQUIRED: If you do not submit your transcript, your application may not be reviewed.) Minimum Requirement: In addition to meeting the basic requirements one of the following minimum requirement criteria must be met to be qualified for this position. Specialized Experience (GS-09): You must have one (1) year of specialized experience that equipped you with the particular knowledge, skills, and abilities (KSA's) to perform successfully the duties of the position, and that is typically in or related to the position to be filled. To be creditable, specialized experience must have been equivalent to at least the next lower grade level (i.e., GS-07) in the normal line of progression for the occupation in the organization. Qualifying examples of specialized experience would typically include but are not limited to: overseeing recruitment and enrollment of participants and providing information on study objectives and constraints for health science research projects; obtaining verbal and/or written informed consent, HIPAA Authorization, and background demographic information from patients for health science research projects; and assisting supervisor with managing the routine, day-to-day activities, and administration of health science research projects. (CLEAR DETAILS OF EXPERIENCE REQUIRED: Your resume must show complete information for each job entry, such as beginning and ending dates of employment, duties performed, and/or total hours worked per week.) OR, Education (GS-09): Applicants may substitute education for the required experience. To qualify based on education for this grade level you must have 2 years of progressively higher level graduate education leading to a master's degree or master's or equivalent graduate degree. This education must have provided the knowledge, skills, and abilities necessary to do the work. NOTE: One year of full-time graduate education is considered to be the number of credit hours that the school attended has determined to represent 1 year of full-time study. If that information cannot be obtained from the school, 18 semester hours should be considered as satisfying the 1 year of full-time study requirement. Part-time graduate education is creditable in accordance with its relationship to a year of full-time study at the school attended. (UNOFFICIAL TRANSCRIPT REQUIRED: If you do not submit your transcript, your application may not be reviewed.) OR, Combination (GS-09): Applicants may also combine education and experience to qualify at this level. You must have a combination of specialized experience and education as described above. Only graduate level education in excess of the amount required for the next lower grade level (i.e., 18 semester hours) may be combined with experience. (UNOFFICIAL TRANSCRIPT REQUIRED: If you do not submit your transcript, your application may not be reviewed.) You will be rated on the following Competencies as part of the assessment questionnaire for this position: Biology Configuration Management Technical Competence 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, 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. 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 is a term appointment not to exceed 1 year 1 day. Term appointments are non-status, nonpermanent appointments of limited duration of more than 1 year, but not more than 4 years and are subject to a 1 year trial period. Should the need warrant, term appointments may be extended without further competition up to a maximum of the 4 year limitation. The appointment to a term position does not confer eligibility for promotion, reassignment, or transfer to other positions or the ability to be non-competitively converted to permanent employment. This position involves a multi-grade career ladder. The major duties listed below represent the full performance level of GS-11. At the GS-09 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. Major duties and responsibilities include but not limited to: Manages Clinical Tests and Collects Data Managing implementation, control and reporting on clinical tests and data collection for difficult clinical research studies Recording data from samples and specimens to ensure that all tracking data is organized and is monitored during the progress of the study Coordinating the accomplishment of the scientific review and evaluation of research programs Participating in initial classification and coding of qualitative/quantitative data and entering coding data into qualitative/quantitative software Assisting with data analysis from a variety of sources, including databases and spreadsheets, and conceive and write reports Respond to inquiries from a sponsor, clinical research coordinating center and/orsite Pl on matters related to data, data compliance, and subject complaints related to data collection Creating and maintaining complex research databases, working with existing VA administrative databases, and managing spreadsheet files for data tracking, budget tracking, and other project management tracking tasks Recording and maintaining results and records of all tests or assessments as per protocol and in a manner complying with research regulations Developing and maintaining/updating study database in accordance to sponsor and/or Pl's specifications. Assist Pl with data analyses and interpretation Recruits and Manages Candidates for Clinical Trials Overseeing, screening, and evaluating recruitment of candidates for clinical research studies via telephone and/or in person Using objective rating techniques to identify potential candidates for participation in study where project design is complex Overseeing recruitment and enrollment of participants, providing information on study objectives and constraints Performing informed consent process throughout the study and continuously educate participants on study processes and procedures Obtaining verbal and/or written informed consent, Health Insurance Portability and Accountability Act (HIPAA) authorization, and background demographic information from patients Performing day-to-day activities related to conducting and overseeing participant interviews and follow-up Coordinating study participant randomization to treatment, works closely with the Research Pharmacy on study drug provision Identifying study adverse events and side effects, symptoms which might require intervention or referrals Research Project Support Assisting supervisor with managing the routine, day-to-day activities, and administration of the project Analyzing processes and documentation to ensure compliance with all technical, regulatory requirements, and information safety regulations Conducting quality assurance evaluations for project data and clinical research instruments Providing technical guidance to research staff regarding regulations, policies, and procedures applicable Responding to general inquiries from program participants, staff, and other stakeholders Managing participant compensation, maintain compensation records, and prepare invoices or electronic funds transfer for reimbursement of participants Assisting in the development of clinical research standard operating procedures/policies and implementation of administrative procedures Organizing and maintaining all study documents for management, data, record keeping and/or compliance purpose Administering screening, advisory and approval processes for the organization's health science research program Performing a variety of duties to maintain specialized data and implement study design. Work Schedule: Monday to Friday; 08:00 a.m. to 04:30 p.m. Recruitment & Relocation Incentives: Not authorized Critical Skills Incentive (CSI): Not Approved"]

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