· Knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporation of them in the conduct of research and care of participants
· Possesses a basic awareness of the Federal regulations governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH guidelines, and HIPAA regulations
· Proficiently prepares and processes new IRB research proposals, amendments, continuing review applications and adverse events according to institutional and departmental policies and procedures and federal regulations
· Possesses a basic awareness of the Vanderbilt policies and regulations governing the protection of human subjects
· Knowledge and understanding of the management and implementation of clinical trial operations
· Understanding and capability to perform the procedures required of each study protocol (obtains training needed to safely and accurately perform or assess required procedures)
· Prepares and stores critical documents required to be maintained and provided to the sponsor prior to, during and after the conduct of a clinical trial
· Performs packaging and ships study medication and specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with IATA and sponsor shipping guidelines
· Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures
· Participates in the determination of eligibility and recruits candidates for study participation. Troubleshoots trial recruitment strategies to ensure trials are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation.
· Provides education and training to appropriate personnel and participants in research specific methodology and procedures
· Maintains open and positive communications with investigators, participants, co-workers, other departments and sponsors.
· Digests complex clinical information to determine if documentation is accurate, complete, and to ensure procedures contain appropriate safeguards. Ability to multi-task, managing multiple assignments while maintaining documentation and study visits and procedures in a timely manner.
· Understands standard of care versus research and continually assesses need for additional protections for the protection of research participants and the accuracy and appropriateness of research data.
· Utilizes nursing skills and processes to identify participant and study problems and utilizes problem solving skills to identify solutions, following through to implement solutions, and assuring goals are met.
· Proactively involved in quality improvement through ongoing assessment and through the identification of issues, and planning and evaluation of quality improvements.
· Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and the public responsible for, or concerned about, protections for human participants of research
· Assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical trials
· Participates in the ongoing informed consent process, ensuring that human subjects, their families, and other health care providers clearly understand what is expected of and from them in the course of participating in a clinical trial
· Utilizes nursing skills to complete research protocols including patient recruitment, screening, scheduling and organizing of study visits, enrollment, assessments, interviews, laboratory and diagnostic studies, medication dispensing and other protocol specific investigational procedures
· Independently uses and documents the nursing process to plan, deliver and evaluate goal focused, individualized, safe, age-specific care as it relates to uncomplicated research participants and with assistance for complicated research participants
· Performs procedures for research as they are described in the protocol, deviating from the protocol only when a subject's safety is at risk and reports all deviations from the protocol to the Principal Investigator and/or senior personnel who will determine of a protocol amendment or other safety assessments are required
· Utilizes knowledge of disease processes to observe for and report adverse events in a timely and accurate manner to the principal investigator and all regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol, policies and procedures and regulations