The Research RN reports to the Chief of the department, Dr McFalls, who is the rating official and approving official, and to
the department Nurse Manager for the practice of nursing. This position is time-limited for 3 years and will provide benefits.
· Evaluate 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
· Screen patient medical records for potential participation in specific clinical trials.
· Conduct the informed consent process with potential research subjects in accordance with all regulatory, ethical, and Institutional Review Board requirements.
· Ensure that the well-being of research subjects is safeguarded and that subjects rights are protected.
· Organize the day-to-day conduct of research activities for assigned studies.
· Educate other departments and staff about new studies, providing guidance in understanding and implementing study protocols.
· Perform study-related procedures as delegated by the Principal Investigator.
· Manage source documentation and accurate case report forms for each study subject, record pertinent observations and data obtained during the study.
· Serve 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.
· Dispense investigational product; monitor and report subjects response.
· Ensure proper collection, processing, and shipment of specimens (e.g. centrifuge, preparation of slides, cryostorage, dry ice packaging, etc.).
· Order and interpret labs and other diagnostic tests per study protocol, and communicate results to Principal Investigator.
· Ensure staff and subject compliance with protocol guidelines and requirements of regulatory agencies. Identify and resolve non-compliance or inconsistent practices.
· Manage the study start-up process, including development of Informed Consent Forms, submission of initial IRB application, and preparation of study start-up materials.
· Collaborate with the Institutional Review Board to ensure that regulatory requirements are identified, communicated, and observed.
· Manage ongoing sponsor and IRB regulatory affairs.
· Oversee the regulatory process, including maintenance of regulatory binders and essential documents. Schedules subjects in VistA; enter notes, orders, and flags in CPRS.
· Oversee monitoring activities by study sponsors.
· Ensure the receipt and proper storage of investigational product and study supplies.
· Prepare and submit necessary reports.
· Identify opportunities for process improvement and implement process changes.