Vanderbilt University Medical Center Research Nurse Specialist 2, Pediatric Pulmonary in Nashville, Tennessee
Research Nurse Specialist 2, Pediatric Pulmonary - 2112046
Job : Research Nursing
Primary Location : TN-Nashville-DOT - VCH Doctor's Office Tower
Organization : Pediatric Pulmonary 104621
Shift: : First Shift
The Division of Allergy, Immunology and Pulmonary Medicine at Vanderbilt supports a robust and growing research program focused on children with primary ciliary dyskinesia (PCD). PCD is a rare disease that affects the motor cilia in the body and results in recurrent pneumonia and recurrent sinus infections. Dr. O'Connor is the medical director for the PCD Foundation North American registry. In this role, he oversees the addition of new participating clinical centers to the registry and helps direct the process for overall data collection.
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.
DEPARTMENT OF PLASTIC SURGERY SUMMARY:
The Department of Plastic Surgery, within the Section of Surgical Sciences, is a vibrant and growing department. Our clinical team has a robust clinical practice and provides a variety of Plastic Surgery related care and partner with many other services within VUMC. We are also proud of our highly respected and competitive residency and fellowship programs, as well as our advanced research initiatives. Research is a vital part of Plastic Surgery at VUMC, and it is powered by research fellows, attending physicians, surgical faculty, staff, and other collaborators and colleagues from various disciplines.
- Full Time/ Exempt Position
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Collect prospective natural history (clinical) data on participants with PCD
Ensure clinical trial readiness. More specifically, the registry consents participants for the option to be contacted about future research trials and thus the registry will also be a recruitment tool for future clinical trials.
As part of being the IRB of record, Vanderbilt is responsible for keeping track of participant enrollment, submitting yearly continuing reviews to the IRB, and assisting other participating sites in submitting site specific amendments. The RNS II would work directly with Dr. O’Connor to complete the IRB regulatory tasks for the registry.
Work directly with Dr. O’Connor (PI) to get new sites added from a regulatory perspective as the PCD Foundation is continuing to add new participating sites to the registry network.
Tasks include, but are not limited to:
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.
Graduate of an approved discipline specific program (or equivalent experience) and 1 year experience
Registered Nurse Required
Physical Requirements/Strengths needed & Physical Demands:
- Light Work category requiring exertion up to 20 lbs. of force occasionally and uses negligible amounts of force to move objects.
Occasional: Lifting over 35 lbs: Raising and lowering objects from one level to another, includes upward pulling over 35 lbs, with help of coworkers or assistive device
Occasional: Carrying under 35 lbs: Transporting an object holding in hands, arms or shoulders, with help of coworkers or assistive device.
Occasional: Balancing: Maintaining body equilibrium to prevent falling when walking, standing, crouching or maneuvering self, patient and equipment simultaneously while working in large and small spaces
Occasional: Climbing: Ascending or descending stairs/ramps using feet and legs and/or hands and arms.
Occasional: Kneeling:Bending legs at knees to come to rest on knee or knees.
Occasional: Crouching/Squatting: Bending body downward and forward by bending legs and spine.Reaching above shoulders: Extending arms in any direction above shoulders.
Occasional: Reaching above shoulders: Extending arms in any direction above shoulders.
Occasional: Sitting: Remaining in seated position
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.
Frequent: Fingering: Picking, pinching, gripping, working primarily with fingers requiring fine manipulation.
Frequent: Bimanual Dexterity: Requiring the use of both hands.
Frequent: Standing: Remaining on one's feet without moving.
Frequent: Walking: Moving about on foot.
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.
Frequent: Communication: Expressing or exchanging written/verbal/electronic information.
Continuous: Auditory: Perceiving the variances of sounds, tones and pitches and able to focus on single source of auditory information
Continuous: Smell: Ability to detect and identify odors.
Continuous: Feeling: Ability to perceive size, shape, temperature, texture by touch with fingertips.
Continuous: 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: Chemicals and Gasses: Medications, cleaning chemicals, oxygen, other medical gases used in work area.
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.
Frequent: Pathogens: Risk of exposure to bloodborne pathogens and other contagious illnesses.
Req ID: 2112046
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