This position is a Temporary position not to exceed 5 years. The position is in Research Service and is funded with a 5 year grant with the option to continue funding if the research is approved for an extension. If you are a current, permanent employee of the Department of Veterans affairs, you will be converted to a temporary position and your will be able to keep your benefits. The VA Cooperative Studies Program (CSP) is a division of the Department of Veterans Affairs Clinical Research and Development Service in Washington, DC. CSP is responsible for planning and conducting large multicenter clinical trials and epidemiology studies. TVHS is one of the statistical and data management coordinating centers within CSP whose mission is to support multicenter clinical trials nationally and internationally. It also collaborates with the VA CSP Clinical Research Pharmacy Coordinating Center (CSPCRPCC), other federal agencies (e.g., branches of the National Institute of Health and Department of Defense), and nonfederal research community, including the pharmaceutical and medical device industries. The majority of the CSP studies adhere to FDA and industry standards for Good Clinical Practices (GCP). The Quality Assurance Nurse Specialist (QANS) role will provide Quality Control and Quality Assurance to help ensure our studies comply with all applicable Federal Regulations. The QANS will participate in all phases of CSPs clinical trial processes: planning, initiation, execution, and closeout. The position may involve some travel to study sites, annual meetings, or other trainings (approximately 10% FTE). Duties may include, but are not limited to: Participate in protocol, informed consent, and operations manual development Participate in data collection form design Participate in the development of the study monitoring and safety plans Collaborate with the VA CSPCRPCC to ensure the quality of site submitted safety reports Provide clinical expertise and support for studies coordinated by the Palo Alto Coordinating Center Provide clinical expertise and support for study endpoint adjudication processes, as needed Remote review of patient medical records for eligibility, serious adverse events, and other data collection activities, as necessary Participate in study site performance monitoring activities and other central monitoring activities Conduct site auditing visits, as needed Provide training to CSP and study personnel on the clinical aspects of studies and sponsor and regulatory requirements, as needed Audit, through random sampling, source document verification processes, as needed Audit the study safety reporting processes Audit Central Study Files and regulatory documents for completeness, accuracy, and regulatory compliance Participate in the program-wide development and review of guidelines, policies, procedures, standards of practice (SOPs, Job Aids, etc), and evaluation of operational outcomes. Maintain the professional competency, knowledge, and skill necessary to remain abreast of developments in good clinical practice and in the conduct of clinical trials. Conduct or collaborate on research projects, publications or presentations related to GCP, as needed. Preferred Experience: Current BLS provider card 1 year RN experience 2 years' experience in clinical research, including experience with FDA regulated studies Good Clinical Practice (GCP) training and knowledge of clinical trial regulations (Pay scale NY67) Work Schedule: Monday -Friday, Day hours (based on the needs of the service) Financial Disclosure Report: Not required
Providing Health Care for Veterans: The Veterans Health Administration is America’s largest integrated health care system, providing care at 1,255 health care facilities, including 170 medical centers and 1,074 outpatient sites of care of varying complexity (VHA outpatient clinics), serving 9 million enrolled Veterans each year.
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