The Centers for Disease Prevention and Control (CDC) has successfully established a network to identify infectious diseases and alert healthcare personnel to threats. The National Personal Protective Technology Laboratory (NPPTL) recognized the need for an equally strong system to monitor the use and assess the effectiveness of personal protective equipment (PPE.
Research Nurse Specialist III's
responsibilities include supervision of technical staff, compliance with government and corporate regulations, supporting all aspects of the contracting process including proposal preparation, negotiation, dispute resolution, and Contracts Management.
Key Functions and Expected Performances:
- Ensures contract compliance by creating and updating queries within various data warehouse systems, performing pricing reviews, and calculating/paying fees.
- Analyzes data to provide insight and recommendations for contracting decisions and performance.
- Creates contract performance reports for external Government customers.
- Must be able to manage across multiple business units and functions
- Ability to process and understand complex Government regulations.
Knowledge and understanding of policies, procedures, and regulations governing human subject's research incorporates them in the conduct of research and care of participants. 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.
Knowledge and understanding of the Vanderbilt policies and regulations governing the protection of human subjects
Has a working knowledge of 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 regulations
Knowledge and understanding of the management and implementation of clinical trial operations
Understands, implements and follows a clinical study protocol and is able to conduct multiple studies independently, including accurate data collection (able to identify when training is needed to safely and accurately perform or assess required procedures. Problem solves when needed to acquire or deliver such training).
Independently prepares and stores critical documents required to be maintained and provided to the sponsor during and after the conduct of a clinical trial
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. Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation in an accurate and timely manner.
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. Collaborates with other departments to seek solutions to global research concerns.
Ability to multi-task, managing multiple assignments while maintaining documentation and study visits and procedures in a timely manner.
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.
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 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, Sponsors, participants and representatives of professional organizations, participant advocates, and 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 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
Encourages open communication with participants by providing them with contact information and being available to answer their calls
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
Performing procedures for research only as they are described in the protocol, deviating from the protocol only when a subject
Job requires Graduate of an accredited nursing program and 5 years of nursing experience.
Previous experience grant writing, contracts and project management, and working knowledge of informatics strongly preferred
Licensure, Certification, and/or Registration (LCR):
Registered Nurse ASN, BSN MSN
Master's Degree preferred
Located in Nashville, Tenn., and operating at a global crossroads of teaching, discovery and patient care,Vanderbilt University and Medical...