Research Nurse Specialist 2, Pediatric Endocrinology 10K sign on bonus
Nashville, TN, USA
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Job Description - Research Nurse Specialist 2, Pediatric Endocrinology 10K sign on bonus (2209857)
Research Nurse Specialist 2, Pediatric Endocrinology 10K sign on bonus -2209857
:TN-Nashville-DOT - VCH Doctor's Office Tower
:Pediatric Endocrinology 104580
The Pediatric Endocrinology Research Program is seeking a Research Nurse Specialist II with at least one year of nursing experience to join the Pediatric Endocrinology clinical research team. We are currently experiencing rapid growth in our research program as our Principal Investigators are quickly becoming renowned as key thought leaders in specialty areas of pediatric endocrinology. Our current clinical research discovery is focused on rare and ultra-rare endocrine diseases in children and their families, such as obesity due to Prader-Willi syndrome, hypothalamic obesity, X-linked hypophosphatemic rickets, hypophosphatasia, and osteogenesis imperfecta. This position is ideal for a nurse seeking to develop clinical research skills. Experienced research nurses are also encouraged to apply. Mentoring will be provided by the Principal Investigators and the Research Projects Manager. This highly collaborative research program promotes meaningful contributions in the development of new evidence for life-changing care for our patients and their families, as well as others across the country who seek out our research care. The Research Nurse Specialist in Pediatric Endocrinology can expect to play a key role as we build a dynamic team with expertise in pediatric endocrinology clinical research and work together to make a great impact upon those living with these rare and ultra-rare diseases.
Under the guidance and supervision of the Principal Investigator, the 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 trail 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.
Key Function #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.
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.
Key Function #2: 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.
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.
Key Function #3: 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
Participants 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 if 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 require 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 ration of the research participant.
Key Function #4: Actively identifies and participates in training, education, and development activities to improve one’s 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 a part of the work
Assumes responsibility for continuous learning, engaging in a minimum of 10 hours of educational activities annually or pursuing and advanced academic education or certifications
Participates in and maintains professional certifications, licensure and credentialing as required of nurses employed at VUMC (i.e., CPR certification)
Further knowledge base by completing the series “Basic of Conducting Clinical Research 102” or equivalent within the first year
**Minimum Qualifications Required**
Graduate of an approved discipline specific program (or equivalent experience) and 1 year experience
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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.
About Vanderbilt Health
Discover Vanderbilt Health: Located in Nashville, TN, and operating at a global crossroads of teaching, discovery and patient care, Vanderbilt Health is a community of individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded, and your abilities challenged. It is a place where diversity – of culture, thinking, learning and leading – is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday.
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