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Research Nurse Specialist II - Allergy/Pulmonary1911854Your Role:Serve as the Lead Nurse Coordinator for multiple investigator-initiated
and industry-sponsored clinical drug trials. Under the guidance and supervision of the Principal Investigator, the Research Nurse Specialist II (RNS II) is responsible for assuring that the integrity and quality of the clinical research trial is maintained and that the trial is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines and Vanderbilt Policy and Procedure. The RNS II plans and implements recruitment procedures for potential participants, manages enrollment of the trial from screening to randomization to study completion, ensures compliance with protocols and overall research and clinical objectives, manages study-related procedures as required by the protocol, maintains accurate and timely documentation and maintains communication with the sponsor.
Assist in budgetnegotiation, contract development, and study start-up
Actively participate inpre-site selection visits, site initiation visits, investigator meetings(occuring infrequently off campus) for study start-up
Use eSMART and buildbilling grids
Schedule researchpatients for visits, order appropriate tests and schedule these (ensure properlinking to research studies)
Carry out visits withthe investigator, documenting study notes, consent, and billing notes
Maintain organized andlegible charts
Maintain regulatorybinders
Notify IRB of studyupdates, SAEs and other important information
Enter data into EDCsystems and other sponsor-supported systems.
Answer queries in atimely manner
Provider oversight andownership of the project
Perform billingreconciliation.
Serve as a supportresearch nurse for the other coordinators in the office with patient-relatedvisits and procedures.
Excellent venipunctureskills / prefer IV insertion/maintenance ability as well
Laboratory processingand shipping (IATA Training)
Perform ECGs
Perform simplespirometry (will teach)
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
Maintains accurate records to document recruitment efforts, telephone follow-up interviews and research data
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
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
Actively identifies and participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development. Pursues avenues to 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
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 10 hours of educational activities annually or pursuing an advanced academic education or certifications
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)
Further knowledge base by completing series Basic of Conducting Clinical Research 102 or equivalent within the first year.
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your expertise will be valued, your knowledge expanded and your abilities
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are part of something that is bigger than themselves, take exceptional pride in
their work and never settle for what was good enough yesterday. Vanderbilt’s mission
is to advance health and wellness through preeminent programs in patient care,
education, and research.VUMC Recent AccomplishmentsBecause we
are committed to providing the best in patient care, education and research, we
are proud of our recent accomplishments:·
USNews & World Report: #1
Adult Hospital in Tennessee and metropolitan Nashville, named to the Best
Hospitals Honor Roll of the top 20 adult hospitals, 10 nationally ranked adult
specialty programs, with 3 specialties rated in the top 10 nationally, Monroe
Carell Jr. Children’s Hospital at Vanderbilt named as one of the Best
Children’s Hospital in the nation, with 10 out of 10 pediatric specialties
nationally ranked.·
Healthcare’sMost Wired: Among
the nation’s 100 “most-wired” hospitals and health systems for its efforts in
innovative medical technology.·
Becker’sHospital Review:
named as one of the “100 Great Hospitals in America”, in the roster of 100
Hospitals and Health Systems with Great Oncology Programs and to its list of
the 100 Hospitals with Great Heart Programs.·
TheLeapfrog Group: One
of only 10 children’s hospitals in the to be named at Leapfrog Top Hospital.·
AmericanAssociation for the Advancement of Science: The School of Medicine has 112
elected fellows·
MagnetRecognition Program: Received
our third consecutive Magnet designations.·
NationalAcademy of Medicine: 22
members, elected by their peers in recognition of outstanding achievement·
HumanRights Campaign Healthcare Equality Index: 6 th year in a rowthat Vanderbilt University Medical Center was a Leader in LGBTQ HealthcareEquality.CAGraduate of an approved discipline specific program (or equivalent experience) and 1 year experienceLicensure, Certification, and/or Registration (LCR):
Registered Nurse Required
Movement
Occasional: Sitting: Remaining in seated position
Occasional: Standing: Remaining on one's feet without moving.
Occasional: Walking: Moving about on foot.
Occasional: Lifting under 35 lbs: Raising and lowering objects under 35 lbs from one level to another
Occasional: Push/Pull: Exerting force to move objects away from or toward.
Occasional: Bending/Stooping: Trunk bending downward and forward by bending spine at waist requiring full use of lower extremities and back muscles
Occasional: Reaching below shoulders: Extending arms in any direction below shoulders.
Occasional: Handling: Seizing, holding, grasping, turning or otherwise working with hand or hands.
Sensory
Occasional: Vision: Clarity of near vision at 20 inches or less and far vision at 20 feet or more with depth perception, peripheral vision, color vision.
Frequent: Noise: May include exposure to occupational noise levels which equal or exceed an 8-hr time-weighted average of 85 decibels, requiring enrollment in VUMC's Hearing Conservation Program which includes training, use of hearing protection, and periodic audiometry.
Continuous: Communication: Expressing or exchanging written/verbal/electronic information.
Job Research NursingOrganization: Allergy/Pulmonary 104383Title: Research Nurse Specialist IILocation: TN-Nashville-Medical Center North (MCN)Requisition ID: 1911854Vanderbilt University Medical Center is committed to principles of equal opportunity and affirmative action.
