1. Plans and implements recruitment procedures for potential participants

2. Manages enrollment of the trial from screening to randomization to study completion

3. Evaluates clinical data, ensures compliance with protocols and overall clinical objectives

4. Serves as a resource for inquiries on study projects.

5. Manages study-related procedures as required by the protocol and maintains communication with the sponsor, IRB, DSMP and other research related entities.

Tasks include, but are not limited to:

• Participates in the determination of eligible candidates for study participation. Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation.
• Knowledge and understanding of policies, procedures, and regulations governing human subject's research. Proficiently prepares and processes new research proposals, amendments, continuing review applications, adverse events, budgets, and D&H accounts according to institutional and departmental policies and procedures and federal regulations
• Has expert knowledge and understanding of the Vanderbilt policies and regulations governing the protection of human subjects
• Functions as a departmental resource regarding clinical trials operations e.g., the operations of the Vanderbilt Institutional Review Board and its requirements for the protection of human subjects
• Maintains a clear understanding of the Federal regulations governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH guidelines, and HiPAA regulation
• Knowledge and understanding of the management and implementation of clinical trial operations
• Capability to understand, implement, and follow a clinical study protocol and is able to conduct multiple studies independently (able to identify when training is needed to safely and accurately perform orassess required procedures. Problem solves when needed to acquire or deliver such training).
• Independently prepares and maintains critical documents required to be maintained and provided to the sponsor during and after the conduct of a clinical trial. Assists with study completion, data lock, study closeout and archiving of study files.
• Collaboratively directs and participates in study team meetings
• Maintains open and positive communications with investigators, participants, co-workers, other departments and sponsors. Collaborates with other departments to seek solutions to global research concerns.
• Digests complex clinical information to determine if documentation is accurate, complete, and to ensure procedures contain appropriate safeguards. Understands standard of care versus research and continually assesses need for additional protections for the protection of research participants and the appropriateness of research data.
• Proactively involved in quality improvement through ongoing assessment and through the identification of issues and planning and evaluation of quality improvement.
• Assists in budget and contract negotiation and facilitates interactions between sponsors and institutional departments.
• Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, representatives of professional organizations, participant advocates, andmembers of 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
• Utilizes nursing skills to complete all research protocols, including patient recruitment, screening, scheduling and organizing of study visits, enrollment, assessments, interviews, laboratory and diagnosticstudies, 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
• Participates in the ongoing informed consent process, ensuring that human subjects clearly understand what is expected of and from them in the course of participating in a clinical trial
• 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 reporting all deviations to the Principal Investigator who willdetermine of a protocol amendment or other safety assessments are required
• Independently uses and documents the nursing process to plan, deliver and evaluate goal focused, individualized, safe, age-specific care as it relates to uncomplicated and complicated research participants, seeking assistance when needed
• Utilizes knowledge of disease processes to observe for and report adverse events in a timely and accurate manner to the principal investigator, DSMB and all regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol, policies and procedures and regulations
• Conducts literature searches as appropriate for new studies and at the time of continuing review. Literature searches are helpful to keep up-to-date in the research field of study in order to determine if significant historical or new findings exist that may impact the risk/benefit ratio of the research participant
• Actively identifies and participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance own professional development. Pursues avenuesto ensure awareness of the latest information available to nurses conducting clinical research, for example
• Reviews the Research Support Services website to obtain information regarding available and required in-services, required certifications and to obtain important updates. Helps provide updates andideas to RSS group for inclusion on their website. Willing to share tools, forms, and techniques with others
• Attends the Clinical Research Staff Council monthly meetings
• Attends in-services advertised by the Institutional Review Board, Research Support Services, professional societies, etc.
• Demonstrates initiative in self-directed learning, as evidenced by attendance of professional development opportunities. Actively seeks new learning opportunities. Sees learning as part of work
• Assumes responsibility for continuous learning, engaging in a minimum of 20 hours of educational activities annually or pursuing an advanced academic education or certifications
• Participates and presents in local, national and international conferences
• Actively participates in publishing opportunities
• Develops and achieves personal and professional goals
• Participates in and maintains professional certifications, licensure and credentialing as required of nurses employed at Vanderbilt (i.e., CPR certification)
• Serves as a role model, mentor, supervisor and consultant across teams and departments to provide expertise and share knowledge
• Assists with orientation of new research staff by serving as an available resource, presenting at educational sessions, guiding new staff to attend useful educational sessions, e.g., IRB updates
• Develops tools to assist new and junior staff and keeps information current according to changing research requirements
• Creates an environment that encourages and supports self-development and learning through regular, immediate feedback
• Assures the development of staff members through orientation, training programs and work experience. Strives to develop individualized professional development plan to guide staff to success, focusing on areas needing growth
• Exhibits strong leadership skills. Applies key concepts of facilitative leadership. Assigns and reviews work; effectively prioritizes tasks and work assignments. Delegates tasks as appropriate and follows up to assure completion. Plans, organizes, and completes projects in an efficient manner