This position is eligible for the Education Debt Reduction Program (EDRP), a student loan payment reimbursement program. You must meet specific individual eligibility requirements in accordance with VHA policy and submit your EDRP application within four months of appointment. Approval, award amount (up to $200,000) and eligibility period (one to five years) are determined by the VHA Education Loan Repayment Services program office after complete review of the EDRP application. Learn more The Clinical Research Nurse Coordinator assumes continuing responsibility for the coordination, management, implementation, and evaluation of VA funded clinical trials within the VHA Research and Development Cooperative Studies Program (CSP) at VA Palo Alto Health Care System - Palo Alto Division. Under the direction of the Site Investigator and the VA Palo Alto CSP Director of the Network of Dedicated Enrollment Sites (NODES), the incumbent will be responsible for the day to day management of study operations, to include subject recruitment, screening, enrollment and follow up; and communication with the study teams and data coordinating center for the study. Incumbent nurse researcher will work under the direct supervision of the Cooperative Studies Program and Network of Dedicated Enrollment Sites (NODES) Director and Manager Work Schedule: Monday thru Friday 8:00am to 4:30pm; to meet the needs of the patient and program needs Telework: Possible Ad Hoc Temporary: Not-to-Exceed 4-years (possibly can be extended) Financial Disclosure Report: Not required The major duties and responsibilities include, but are not limited to: Responsible to the VA Cooperative Studies Program's NODES Director and Manager and indirectly to the Associate Chief of Psychiatry. Works directly with site investigator(s), study coordinator and other facility staff. Responsible for assisting in the initiation of new studies, including submission of required regulatory documents to IRB and R & D committees and subcommittees, initiation visits by study sponsor, preparation of informed consent, data collection and evaluation and recruitment of potential study participants. Oversees the day-to-day activities of the project and acts as the resource person for all questions about the study activities locally. Maintains a high level of knowledge and understanding of the study protocol, including all requirements for patient visits, obtaining informed consent, patient visit schedules, test procedures, laboratory information and device accountability requirements. Assisting in the selection, contacting and scheduling potential research subjects for diagnostic and research evaluation visits. Assisting in the assessment of inclusion and exclusion criteria for each potential patient. Coordinate and conduct patient care visits and assure all procedures are conducted in compliance with the study protocol. Responsible for maintaining close contact and ongoing supportive relationship with study patients during treatment and follow-up phases, tracking adherence to study protocol. Administer structured assessments, performs study related assessments. Perform venipunctures for collection of blood samples required by study protocol, including processing of samples and proper shipment per regulatory guidelines. Administers investigational drug product. Provides education and instruction on study drug administration, and possible adverse effects. Collects and maintains accurate source documentation for each study participant. Accurately documents in CPRS, completes data entry and responds to sponsor queries; initiates physician orders and creates source documents. Maintains regulatory documents and sponsor files. Assures confidentiality and security of human participants and data collected in accordance with HIPAA regulations. Adheres to Federal Privacy regulations. Acts to protect the rights, safety and well-being of human participants involved in clinical trials. Complies with ethical standards for research conduct. Requires knowledge of good clinical practices as well as the ability to work independently. Fosters collaborative research relationships using excellent communication and interpersonal skills with investigators and participants. Interact with Site Investigators as needed to ensure patients receive appropriate medical and psychiatric evaluation and care when needed, and alerts Site Investigators of adverse events when appropriate. Participates in monthly Cooperative Studies Program meetings and interacts with the Cooperative Studies Clinical Research Pharmacy Center in Albuquerque NM to facilitate study monitoring and research data integrity.
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.