Job Summary

Under the guidance and supervision of the Principal Investigator, the Research Nurse Specialist III (RNS III) 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 III independently plans and implements recruitment procedures for potential participants, manages enrollment of the trial from screening to randomization to study completion, evaluates clinical data, ensures compliance with protocols and overall clinical objectives, serves as a resource for inquiries on study projects, manages study-related
procedures as required by the protocol and maintains communication with the sponsor, IRB, DSMB and other research related entities. Candidates should be certified neonatal intensive care unit (NICU) nurses with significant experience in coordinating clinical trials in that environment.

Key Functions and Expected Performances

• Applies knowledge and understanding of policies, procedures and regulations governing human subjects research and incorporates them in the conduct of research and care of the participants
• Demonstrates knowledge and understanding of the management and implementation of clinical trial operations
• 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 public responsible for or concerned about protections for human participants of research.
• Proficiently prepares and processes new research proposals, amendments, continuing review applications, adverse events budgets and D&H accounts according to institutional and departmental policies and procedures and federal regulations
• Supervise and Coordinate research related activities of current clinical protocols
• Administer data collection for state mandated reporting as well as quality assurance and benchmarkng for NICU Standards of Practice
• Completion and maintenance of federally mandated paperwork, including IRB applications, informed consent, serious adverse events and annual reviews
• Review of new research protocols with consideration to subject recruitment availability, resoure utilization and financial impact
• Communication, education, and resource development for nurses, physicians and ancillary personnel utilizing web-based technologies
• Networking and education with physicians, nurses and ancillary personnel to assure protocol compliance and study protocol integrity.

Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery and patient care, VUMC 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 your 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. Vanderbilt's mission is to advance health and wellness through preeminent programs in patient care, education, and research.

VUMC Recent Accomplishments

Because we are committed to providing the best in patient care, education and research, we are proud of our recent accomplishments:

* US News & 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's Most Wired: Among the nation's 100 "most-wired" hospitals and health systems for its efforts in innovative medical technology.

* Becker's Hospital 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.

* The Leapfrog Group: One of only 10 children's hospitals in the to be named at Leapfrog Top Hospital.

* American Association for the Advancement of Science: The School of Medicine has 112 elected fellows

* Magnet Recognition Program: Received our third consecutive Magnet designations.

* National Academy of Medicine: 22 members, elected by their peers in recognition of outstanding achievement

* Human Rights Campaign Healthcare Equality Index: 6^th year in a row that Vanderbilt University Medical Center was a Leader in LGBTQ Healthcare Equality

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.

Movement

• 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.

Sensory

• 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.

Environmental Conditions

• 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.