Vanderbilt University Medical Center Research Nurse Specialist II (Pediatric Gastroenterology) in Nashville, Tennessee
Proficiently prepares and processes new research proposals, amendments, continuing review applications, adverse events, assist the PI and AO in compiling budgets, and D&H accounts according to institutional and departmental policies and procedures and federal regulations.
· 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
· 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.
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
Keep abreast of trends in field of study and assist in the preparation of materials for publication
· Read professional journals and attend meetings and/or seminars.
· Attend and/or make presentations at weekly research group personnel meetings.
· Edit and/or type manuscripts according to accepted practices.
· 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
· Create information materials related to the research/study for dissemination to study participants, researchers, PIs, community.
Graduate of an approved discipline specific program and 1 year experience
Licensure, Certification, and/or Registration (LCR):
- Registered Nurse Required
Physical Requirements/Strengths needed & Physical Demands:
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: Crawling:Moving about on hands and knees or hands and feet.
Occasional: Reaching below shoulders: Extending arms in any direction below shoulders.
Occasional: Handling: Seizing, holding, grasping, turning or otherwise working with hand or hands.
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.
Occasional: 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.
Occasional: Chemicals and Gasses: Medications, cleaning chemicals, oxygen, other medical gases used in work area.
Occasional: Pathogens: Risk of exposure to bloodborne pathogens and other contagious illnesses.
Occasional: Radiation: May be exposed to occupational radiation, requiring enrollment in VUMC's Radiation Safety Program which includes training, use of personal protective equipment with lead shielding, and personal dose monitoring.
Occasional: Climate: Ability to withstand exposure to atmospheric extremes including heat, cold, humidity, and barometric pressure changes.
Job Research Nursing
Organization: Pediatric Gastroenterology 104585
Title: Research Nurse Specialist II (Pediatric Gastroenterology)
Location: TN-Nashville-DOT - VCH Doctor's Office Tower
Requisition ID: 1710062