(CRITICAL CARE, SPECIALTY CLINICS, OPERATING ROOM & RELATED AREAS)
The Research RN reports to the Director for Surgery/Specialty Care Service Line Research Activities, who is the rating official and approving official with associated responsibilities to the Investigators and Surgery/Specialty Care Service Line Director.
The Research RN applies and directs clinical research projects within the Surgery/Specialty Care Service Line. The purpose of this position is to work independently under the direction of the Investigators to conduct clinical research activities including, but not limited to, subject recruitment, enrollment, assessment, and support during their study participation; a variety of complex activities in the collection, documentation, and reporting of clinical research data; and overall project management responsibilities in accordance with Federal regulations, IRB requirements, and Good Clinical Practice guidelines. The Research RN will have both clinical (includes all elements of the research investigation process and procedure) and administrative function(includes oversight of research studies and data preparation/presentation).
Minimum two years nursing experience, preferably in the area of clinical research practice.
Knowledge of established research standards.
Prior clinical research experience preferred.
Analytical skills and the ability to evaluate the quality of data collected and progress toward overall program objectives.
Computer proficiency, including familiarity with Electronic Health Record (Computerized Patient Record System.
Evaluates new study protocols and provide recommendations to the Principal Investigator for study selection regarding:
Patient population against enrollment requirements
Fit with current research portfolio
Availability of research staff
Required equipment and external resources
Adequacy of preliminary budget
Screens patient medical records for potential participation in specific studies.
Requires patient contract to conduct the informed consent process with potential research subjects in accordance with all regulatory, ethical, and Institutional Review Board requirements.
Ensures that the well-being and compliance of research subjects is safeguarded and that subjects’ rights are protected.
Organizes & conducts the day-to-day research activities for assigned studies.
Educates other departments and staff about new studies, providing guidance in understanding and implementing study protocols.
Performs study-related procedures as delegated by the Principal Investigator.
Manages source documentation and accurate case report forms for each study subject, record pertinent observations and data obtained during the study.
Serves as primary liaison with principal investigator, staff, internal/external resources and sponsor regarding patient care issues and progress of the study.
Monitor subjects' progress, including documentation and reporting of adverse events.
Orders and interprets labs and other diagnostic tests per study protocol, and communicate results to the Investigator(s).
Ensures staff and subject compliance with protocol guidelines and requirements of regulatory agencies. Identify and resolve non-compliance or inconsistent practices.
Contributes to resulting research publications.
Compiles clinical data and enters into a database.
Reviews & assess data collected.
May perform other clinical duties (not related to research projects) as assigned by Research RN, Research Director or Surgery/Specialty Care Service Line Leadership.
Manages the study start-up process, including development of Informed Consent Forms, submission of initial IRB application, and preparation of study start-up materials.
Collaborates with the Institutional Review Board to ensure that regulatory requirements are identified, communicated, and observed.
Manages ongoing sponsor and IRB regulatory affairs.
Oversees the regulatory process, including maintenance of regulatory binders and essential documents. Schedules subjects in VistA; enter notes, orders, and flags in CPRS.
Prepares and submits reports to IRB, Sponsor & Director of Research.
Identifies opportunities for process improvement and implement process changes.
Maintains & secures appropriate files.
Ensures compliance with Federal regulations to ensure clinical research is complaint and performed within accordance of regulations.
Assists the Investigator(s) in the development of materials and protocols.
Appropriately trains individuals involved in the study related to (but not limited to) protocol requirements, schedule of visits, execution of research plans, etc. Assures all key personnel or persons engaged in the research project have met training requirements in accordance with Federal regulations. Maintains documentation of training.
May include budget preparation for Investigators.
Attend meetings as required or requested.
Performs other administrative duties (may not be related to research projects) as assigned by Research RN, Research Director or Surgery/Specialty Care Service Line Leadership.