This Position is located in the Research and Education Service at the Salisbury VA Medical Center, Salisbury, NC. Work is considerably difficult and consists of a great degree of accountability, autonomy and responsibility. Incumbent is expected to a considerable extent, exercise independent practical nursing judgment. They possess and apply a comprehensive working knowledge of the principles, arts and science of practical nursing and research administration. Major Duties *Perform initial patient assessment to assure potential participants meet inclusion/exclusion criteria of the research study to which being recruited, consulting with the Study Coordinator for complex clinical trials. Independently handle most aspects of enrollment process, including recruiting, screening, scheduling, obtaining informed consent for rudimentary studies, baseline patient assessments and follow-up assessment(s) according to research protocol. Interview human research participants to collect health information via telephone and/or in person, conducting follow-up procedures as necessary. *Assist in the preparation of Institutional Review Board and Research & Development Committee submissions, assuring that VA, HHS and FDA regulations related to the protection of human subjects are followed. *Must assure that the potential participants fully understands the risk/benefit ratio and is competent to give informed consent. *Retrieves patient information from other clinical/management settings and other computer systems. Must maintain confidentiality of patient medical records. *Documents changes and consults with M.D. Principal Investigator and/or Study Coordinator to assure continued study participation is in the subject's best interest. *Completes source documentation for study participants and maintains regulatory documentation to meet national standards as well as additional local requirements. *This record keeping is extremely critical and requires vigilance to meet Office of Research Oversight, FDA and accrediting body requirements to participate in research. *Assists in the preparation of study documentation for auditors, including VA and FDA auditors. Documentation is thorough and meets study requirements at all times. *Assists the Study Coordinator in the day-to-day activities of one or more complex research studies, including all actions related to enrolling and consenting participants and the proper collection and of data. *Conducts the proper collection and shipment of blood and body fluid specimens, per individual protocols, while maintaining proper blood-body fluid precautions. Assists the Study Coordinator in identifying potential human research subjects based on eligibility criteria from Computerized Patient Record System (CPRS) or other 2 database sources, performing medical record abstractions and maintaining tracking databases to chart study progress per study protocols and regulatory requirements. *Responsible for quality assurance activities related to research protocols and for correcting any deviations from QA standards. *Adheres to Joint Commission, regulatory and accrediting body standards, champions safe work practices, models high quality customer services and participant advocacy and assures compliance of all research interventions. *Knowledge and skill to immediately recognize potential urgent or emergent subject situations and then immediately notify MD and/or Study Coordinator for appropriate team intervention. *Demonstrates broader knowledge and skill to readily recognize the more subtle signs and symptoms of potential or actual drug reactions with studies using medical interventions, promptly informing the principal investigator of observed changes in subject's condition and initiates appropriate, prescribed interventions. *Actively seeks out educational opportunities to enhance nursing knowledge and skills and provides leadership in assisting other staff in improving and advancing his/her nursing practice and research skills. *Conducts the Informed Consent process for less complex studies with research subjects and/or Legally Authorized Representatives (LAR), assuring that subjects and/or LAR fully understand study objectives, risks/benefits, study procedures and their role and responsibilities. Enlists the Study Coordinator's assistance as necessary. *Initiates instruction to subjects regarding study drug or device, diagnostic testing study procedures, potential adverse effects of study drug. *Acts as resource person for subjects and family to answer questions regarding research study procedures, consulting with the Study Coordinator as needed. All other duties assigned by Service Line Leadership. Work Schedule: Monday - Friday, 08:00am to 04:30pm Financial Disclosure Report: Not required
Internal Number: 598993000
About Veterans Affairs, Veterans Health Administration
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.