The Department of Neurology at Vanderbilt University is seeking a Family or Adult Board-Certified Nurse Practitioner (NP) or Physician Assistant (PA) t o conduct and administer clinical examinations and assessments, including performing lumbar punctures (LPs) and other duties related to the clinical research activities in our Neurocognitive Disease Division. The successful candidate must be licensed in Tennessee as an Advanced Practice Nurse/Advanced Practice Registered Nurse (APN/APRN) or PA, possess a minimum of 2 years' experience as an NP or PA, preferably as an Adult-Gerontology Primary Care Nurse Practitioner (AG-PCNP-BC) or PA. Prior experience and certification to perform LPs, while not necessary, would be a plus; training for certification will be provided upon employment. This part-time position (0.5 FTE/20 hours per week, ideally 9AM-1PM Monday - Friday) is eligible for partial Vanderbilt benefits, including health and prescription coverage as well as VUMC's 403(b) retirement plan.

Under the leadership of the Divisional Director, Dr. Daniel Claassen, and in collaboration with an interdisciplinary research team composed of neurologists, neuropsychologists, speech language pathologists, staff, and trainees, you will assist with oversight, management, and implementation of several concurrent National Institutes of Health and industry-funded clinical research studies, including all data collection procedures and the implementation and monitoring of project goals.

Current research efforts include observational and randomized controlled interventional studies for patients with Huntington's Disease, Parkinson's Disease, Alzheimer's Disease, Multiple System Atrophy, Progressive supranuclear palsy, and Frontotemporal Dementia. You will be trained and certified to perform neurological and physical examinations, conduct structured and semi-structured clinical interviews and clinical motor, cognitive, and behavioral assessments per study protocol. Several of these studies require collection of cerebrospinal fluid; the successful candidate will be trained to perform lumbar punctures using an extraction/syringe technique with an atraumatic needle. You will triage participant incidental findings and liaise with their healthcare providers regarding findings and any necessary follow-up. To the extent possible and in accordance with study protocol, you may also be asked to provide feedback to research participants and their families regarding results from clinical assessments, tests, and/or imaging findings. You will also be responsible for developing and maintaining excellent relationships with the interdisciplinary study teams, study participants and their families to enhance retention and compliance with study protocols. Under the guidance of the Center Director, you will assure that the integrity and quality of clinical research procedures are maintained and conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, and institutional policies and procedures.

The NP or PA candidate should have a strong foundation in evidenced based practice/education and provide an environment of safe quality care. The successful candidate will demonstrate an advanced level of medical and nursing knowledge, clinical/technical competence, sound clinical judgment, professional communication skills, timely and compliant documentation, and is responsible for professional development and competency validation.

Key Functions and Expected Performances:

1. Regulatory & Compliance
1. 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.
1. Possesses an awareness of and ensures study activities occur in compliance with Vanderbilt's and the Federal regulations governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH guidelines, and HIPAA regulations.

1. Study Lifecycle Management
1. Possesses sound knowledge and understanding of the management and implementation of clinical trial operations.
2. Possesses awareness of the operations of the Vanderbilt Institutional Review Board and its requirements for the protection of human subjects
1. Attends IRB 101 in-service and completes IRB testing requirements within the first three months of employment and prior to beginning interactions with human subjects.
2. 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.
3. Maintains accurate and timely documentation and communication (ALCOA) with the research team and study sponsor.
1. 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.
2. Maintains accurate records to document recruitment efforts, telephone follow-up interviews and research data
1. Documentation is timely, meets care compliance standards and captures patient acuity.
3. Assists with study completion, data lock, study closeout and archiving of study files
4. Ensures completeness and continuity of all study data performs ongoing checks of clinical data that has been entered on the case report forms (paper or electronic) to ensure that it is being entered in a timely and accurate manner
5. Reviews all study data queries correcting any inaccurate data and flagging questionable data for resolution.
4. Plans and implements the recruitment, screening, counseling, and consenting of prospective study participants in accordance study protocols and Vanderbilt's Institutional Review Board.
1. Participates in the determination of eligibility and recruits candidates for study participation.
1. Assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical trials.
2. 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.
2. Troubleshoots trial recruitment strategies to ensure trials are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation.
3. Manages enrollment of the trial from screening to randomization to study completion.
5. Ensures compliance with study protocols and overall research and clinical objectives:
1. Demonstrates understanding and capability to perform the procedures required of each study protocol
1. Obtains training and certification when needed to safely and accurately perform or assess required procedures.
2. Effectively manages and performs study-related procedures and documentation according to protocol:
1. 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
2. Performs and documents in the medical record and study electronic data capture system, study participants' complete medical and medication histories, physical and neurological examination, clinical assessments and questionnaires per study protocol.
3. 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.
4. 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
3. Provides education and training to appropriate personnel and participants in research specific methodology and procedures.
6. Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures.
7. Performs packaging and ships study medication and specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with IATA and sponsor shipping guidelines
2. Effective Communication
1. Maintains ongoing, open and positive communications with investigators and study team, study participants and their family/caregivers/ advocates, co-workers, department and institutional personnel, and study sponsors and monitors.
1. Collaboratively participates in study team meetings
2. Encourages open communication with participants by providing them with contact information and being available to answer, address or refer their calls
2. Coordinates care and collaborates with the Divisional Director, interdisciplinary research team, and study physicians as needed to ensure continuity of care throughout study timelines.
3. Serves as an advocate for human subjects by establishing and maintaining open and positive communication with investigators, research and institutional staff, sponsors, study participants and their family members/caregivers/advocates, representatives of professional organizations, and the public responsible for, or concerned about, protections for human participants of research.
3. Professional Acumen
1. Ability to multi-task, managing multiple assignments while maintaining documentation and study visits and procedures in a timely manner.
1. Considers scheduling subject appointments to utilize their and personnel time efficiently
2. Digests complex clinical information to determine if documentation is accurate, complete, and to ensure procedures contain appropriate safeguards.
3. 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.
4. 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.
5. Proactively involved in quality improvement through ongoing assessment and through the identification of issues, and planning and evaluation of quality improvements.
6. Develops and achieves personal and professional goals
7. Demonstrates initiative and assumes responsibility for continuous self-directed learning:
1. Actively identifies, seeks, and participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development.
2. Conducts literature searches and assesses new information as appropriate regarding new studies and at the time of continuing review 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
3. Seeks opportunities for active engagement in research and the analysis of evidenced based practice.
4. Participates in and maintains professional certifications, licensure and credentialing as required of nurses employed at Vanderbilt (i.e., CPR certification)
1. Engages in a minimum of 10 hours of educational activities annually or pursuing an advanced academic education or certification.
2. Maintains CEUs, and membership in a professional organization.
5. Further knowledge base by completing series Basic of Conducting Clinical Research 102 or equivalent within the first year
6. Reviews the Research Support Services website to obtain information regarding available and required in-services, required certifications and to obtain important updates
7. Attends the Clinical Research Staff Council monthly meetings
8. Attends in-services advertised by the Institutional Review Board, Research Support Services, professional societies, etc.