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Research Nurse Specialist I
Vanderbilt Health
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Research Nurse Specialist I

Vanderbilt Health

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Details
Posted:
February 9, 2021
Location:
Nashville, Tennessee
Salary:
Open
Discipline:
Academic / Research
Description
Research Nurse Specialist I
Cardiovascular Medicine

JOB SUMMARY:
Under the guidance and supervision of the Principal Investigator, the Research Nurse Specialist I 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 Research Nurse Specialist I 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 Summary:

The Division of Cardiovascular Medicine is comprised of more than 140 faculty members dedicated to understanding, preventing, and treating cardiovascular disease.

Our physicians perform approximately 130,000 clinic visits annually. We offer the most advanced technologies to treat coronary artery disease, arrhythmias, and structural heart disease in new, state-of-the-art cardiac catheterization and electrophysiology laboratories. In 2018, our heart transplant program was the second busiest in the world, with 100 adult heart transplants performed that year. Our multi-disciplinary programs in prevention, lipid management, inherited heart disease, adult congenital heart disease, vascular medicine, and cardio-oncology are unique in the region and among the busiest nationally.

A fundamental component of our mission is research aimed at understanding the causes of cardiovascular disease and the translation of this knowledge to improve patient care.

View how Vanderbilt Health employees celebrate the difference they make every day:

Discover Vanderbilt University Medical Center:

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.


Our Nursing Philosophy:

We believe highly skilled and specialized nursing care is essential to Vanderbilt University Medical Center's mission of quality in patient care, education and research. We believe nursing is an applied art and science focused on helping people, families and communities reach excellent health and well-being.


Achieve the Remarkable:

Learn more about VUMC Nursing:

* Nursing Careers : http://www.vumcnursingcareers.com/index.html

* Benefits : http://www.vumcnursingcareers.com/benefits.html

* Our Nursing Philosophy : http://www.vumcnursingcareers.com/philosophy.html

* Our Nursing Leadership : http://www.vumcnursingcareers.com/leadership.html

* Shared Governance : http://www.vumcnursingcareers.com/shared-governance.html

* Education & Professional Development : http://www.vumcnursingcareers.com/professional-development.html

* Life In Nashville : http://www.vumcnursingcareers.com/nashville.html

* VUMC Nursing : http://www.mc.vanderbilt.edu/root/vumc.php?site=vanderbilt-nursing


KEY RESPONSIBILITIES:
  • Conveys a basic knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporates 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
  • With assistance, 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
  • Possesses a basic awareness of the operations of the Vanderbilt Institutional Review Board and its requirements for the protection of human subjects (Seeks to attend IRB 101 in-service and completes IRB testing requirements prior to beginning interactions with human subjects)
  • Communicates a basic knowledge and understanding of the management and implementation of clinical trial operations:
  • Exhibits the capability to understand and follow a clinical study protocol
  • Understands and is capable of performing the procedures required of each study protocol (obtains training needed to safely and accurately perform or assess required procedures)
  • With assistance, 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
  • Identifies and procures equipment and supplies needed to fulfill project requirements
  • With direction, records data from source documentation onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness and source documentation
  • Performs packaging and ships study medication and specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with IATA and sponsorshipping guidelines
  • With supervision, 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
  • With direction assists with study completion, data lock, study closeout and archiving of study files ensures completeness and continuity of all study data performs ongoing checks of clinical data that has been entered on the case report forms (paper or electronic) to ensure that it is being entered in a timely and accurate manner reviews all study data queries correcting any inaccurate data and flagging questionable data for resolution
  • Collaboratively participates in study team meetings
  • 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
  • With guidance assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical trials
  • Continuously assesses participants to ensure continued eligibility for participation in research
  • 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
  • Encourages open communication with participants by providing them with contact information and being available to answer, address or refer their calls
  • With supervision 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
  • Considers scheduling subject appointments to utilize their and personnel time efficiently
  • 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
  • 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 5 hours of educational activities annually or pursuing an advanced academic education or certifications
  • Participates in and maintains professional certifications, licensure and credentialing as required of nurses employed at Vanderbilt (i.e., CPR certification)
  • Further knowledge base by attending the Basic Research 101 within first three months of employment date

Internal Number: 2012572
About Vanderbilt Health
Vanderbilt University Medical Center is home to Vanderbilt University Hospital, The Monroe Carell Jr. Children’s Hospital at Vanderbilt, the Vanderbilt Psychiatric Hospital and the Vanderbilt Stallworth Rehabilitation Hospital. These hospitals experienced more than 61,000 inpatient admissions during fiscal year 2015. Vanderbilt’s adult and pediatric clinics treated nearly 2 million patients during this same period. Vanderbilt University Hospital and the Monroe Carell Jr. Children’s Hospital at Vanderbilt are recognized again this year by U.S. News & World Report’s Best Hospitals as among the nation’s best with 18 nationally ranked specialties. Vanderbilt University Medical Center is world renowned because of the innovation, work ethic and collegiality of its employees. From our health care advances to our compassionate care, Vanderbilt owes its accomplishments and reputation to staff and faculty who bring skill and drive and innovation to the medical center day after day. World-leading academic departments and comprehensive centers of excellence pursue scientific discoveries and transformational educational and clinical advances across the entire spectrum of health and disease.As t...he largest employer in middle Tennessee, we welcome those who are interested in ongoing development in a caring, culturally sensitive and professional atmosphere. Most of us spend so much of our lives at work, we want to be part of maintaining a workplace in which people support one another and encourage reaching for excellence. Many high-achieving employees stay at Vanderbilt because of the professional growth they experience and because of their appreciation of Vanderbilt’s benefits, public events and discussions, athletic opportunities, beautiful setting and, above all, sense of community and purpose.Vanderbilt and its employees share a set of mutual expectations that have been created with productivity, legality, fairness and safety always in mind. We believe that our investment in training and compensating employees multiplies in value when we enable individuals to deliver their best performance for the benefit of us all.
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