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 diverse 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. Vanderbilt Health recognizes that diversity is essential for excellence and innovation. We are committed to an inclusive environment where everyone has the chance to thrive and 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.

Organization:

Pediatric Infectious Disease

Job Summary:

JOB SUMMARY

This position is with the Halasa Lab, led by Dr. Natasha Halasa, within the Division of Pediatric Infectious Diseases at Vanderbilt University Medical Center. Our laboratory research concentrates on the etiology, epidemiology, prevention, and pathobiology of infectious diseases.

Under the guidance and supervision of PI, the Research Nurse Specialist 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 GCP, federal and sponsor regulations and guidelines and Vanderbilt Policy and Procedure. The RNS-III independently plans and implements recruitment procedures for potential participants, manage enrollment of the trial from screening to randomization to the study completion, evaluates clinical data, ensures compliance with protocols and overall clinical objectives, serves as a resource for inquires on the study projects, manages study-replated procedure as required by the protocol and maintains communication with the sponsor IRB, DSMB, and other research related entities.

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KEY RESPONSIBILITIES

Human Subjects Research Regulations and Policies

• 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 Utilizes knowledge of disease processes to observe for and report adverse events to the principal investigator and all regulatory authorities as required by protocol, policies and procedures and 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)

• 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

• Digests complex clinical information to determine if documentation is accurate, complete, and to ensure procedures contain appropriate safeguards.

Clinical Staff Supervision & Training

• Trains individuals and oversee their work

• Supervisors research coordinators

• Oversees the team training on clinical protocols, including eligibility and exclusion criteria

• Oversees that pertinent patient data is entered into REDCap database completely and accurately and in a timely manner.

• Ensures deadlines are met for study

• Provides education and training to appropriate personnel and participants in research specific methodology and procedures

• Ability to multi-task, managing multiple assignments while maintaining documentation and study visits and procedures in a timely manner.

Clinical Study Startup and Management

• Read and become knowledgeable of all study protocols, particularly in order to determine specific criteria for eligibility or exclusion Assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical trials

• Utilizes nursing skills to complete all research protocol, including patient recruitment, screening, and organizing study visits, enrollment, assessments, interview, laboratory and diagnostic studies, medication dispensing, and other protocol specific investigation 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

• Sets up timeline of tests and required 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.

• Participates in the recruitment of eligible candidates for study participation. Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation.

• Abstracts and records all patient data essential to the study onto required case report forms.

• Collects and monitors all study patients records to document treatments and outcomes as required by the protocol

• Communicates with non-research hospital staff regarding tests and procedures, as needed

• Prepares kits for procedures and labels tubes with specific times and dates for collection.

• Communicates with laboratory staff regarding study visits, sample collection, and transport

• Performs packaging and ships study medication and specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with IATA and sponsor shipping guidelines

• Conducts follow-up of study patients.

• Calls or sends questionnaires to patient to check outcomes, survival rate, and quality of life.

Clinical Study Quality Assurance

• Reports all adverse reactions according to VUMC and protocol guidelines

• Ensures complete source documentation in record

• Assists with monitoring compliance with protocol and regulations

• Leads in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures

• Meets with and assists in response to sponsors and monitors to ensure compliance with protocol and applicable regulations.

• Independently 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 Examine data and records to ensure compliance with protocol.

• 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.

• 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

• Proactively involved in quality improvement through ongoing assessment and through the identification of issues, and planning and evaluation of quality improvements.

• Attends Clinical Research Staff Council and participates in CRS activities

• Assumes responsibility for continuous learning

• Works on research protocols and SOPs

• Maintains open and positive communications with investigators, participants, co-workers, other departments and sponsors.

TECHNICAL CAPABILITIES

• Evidence-Based Practice (Intermediate): Demonstrates ability to integrate evidence from multiple sources and determine if a practice change should occur. Shares knowledge with peers and other clinical team members independently.

• Care Planning (Intermediate): Demonstrates ability to anticipate and plan for complex resource needs, identify discrete tasks, set priorities, schedule activities, meet deadlines, and organize work. Collaborates with members of the health care team to identify desired outcomes. Anticipates problems and obstacles before they arise. Able to adapt changes to patient care and area needs with minimal loss of disruption and loss of productivity. Develops creative ideas and takes innovative action to achieve planned goals and objectives. Possesses sufficient knowledge, training, and experience to role model and coach less experienced peers.

• Nursing Patient Assessment & Evaluation (Intermediate): Demonstrates mastery of patient assessments and evaluations in practical applications of a difficult nature. Conducts primary care patient interviews and physical examinations. Conducts inquiry with a thorough series of questions when patients state an ailment or complaint in order to accurately identify and elaborate on the problem. Possesses sufficient knowledge, training, and experience to role model and coach less experienced peers.

• Nursing Patient Education (Intermediate): Demonstrates mastery of patient education in practical applications of a difficult nature. Possesses sufficient knowledge, training, and experience to be capable of providing patient health education services without requiring instruction from others. Able to train and educate by setting the example, giving technical instruction, providing leadership, and generally raising the level of performance of others while on the job.

• Regulatory Compliance (Intermediate): Demonstrates knowledge of the appropriate rules and regulations and apply them in difficult, stressful and complex situations. Able to interpret and explain rules and regulations that are ambiguous or unclear. Directs others in interpreting rules and regulations on the job and trains others in them.

• Scientific Knowledge (Intermediate): Knowledge of different scientific studies including but not limited Biomedical, Applied, and Physical.

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.

As a Vanderbilt University Medical Center employee, you make a difference to our patients and their families by bringing compassion and care to those in need of hope and healing. Please see our current employee benefits offered:

• Affordable High Quality Health Plan Options

• Dental and /or vision plan

• 403 (b) retirement plan

• Paid Time off (flex PTO)

• Tuition Reimbursement and adoption assistance (maximums applied)

• Short-Long term disability

• Subsidized backup childcare

• And many more... Ask us about our current inpatient nursing supplemental Pay Program!

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

Core Accountabilities:

Organizational Impact: Independently delivers on objectives with understanding of how they impact the results of own area/team and other related teams. Problem Solving/ Complexity of work: Utilizes multiple sources of data to analyze and resolve complex problems; may take a new perspective on existing solution. Breadth of Knowledge: Has advanced knowledge within a professional area and basic knowledge across related areas. Team Interaction: Acts as a "go-to" resource for colleagues with less experience; may lead small project teams.

Core Capabilities :

Supporting Colleagues: - Develops Self and Others: Invests time, energy, and enthusiasm in developing self/others to help improve performance e and gain knowledge in new areas. - Builds and Maintains Relationships: Maintains regular contact with key colleagues and stakeholders using formal and informal opportunities to expand and strengthen relationships. - Communicates Effectively: Recognizes group interactions and modifies one's own communication style to suit different situations and audiences. Delivering Excellent Services: - Serves Others with Compassion: Seeks to understand current and future needs of relevant stakeholders and customizes services to better address them. - Solves Complex Problems: Approaches problems from different angles; Identifies new possibilities to interpret opportunities and develop concrete solutions. - Offers Meaningful Advice and Support: Provides ongoing support and coaching in a constructive manner to increase employees' effectiveness. Ensuring High Quality: - Performs Excellent Work: Engages regularly in formal and informal dialogue about quality; directly addresses quality issues promptly. - Ensures Continuous Improvement: Applies various learning experiences by looking beyond symptoms to uncover underlying causes of problems and identifies ways to resolve them. - Fulfills Safety and Regulatory Requirements: Understands all aspects of providing a safe environment and performs routine safety checks to prevent safety hazards from occurring. Managing Resources Effectively: - Demonstrates Accountability: Demonstrates a sense of ownership, focusing on and driving critical issues to closure. - Stewards Organizational Resources: Applies understanding of the departmental work to effectively manage resources for a department/area. - Makes Data Driven Decisions: Demonstrates strong understanding of the information or data to identify and elevate opportunities. Fostering Innovation: - Generates New Ideas: Proactively identifies new ideas/opportunities from multiple sources or methods to improve processes beyond conventional approaches. - Applies Technology: Demonstrates an enthusiasm for learning new technologies, tools, and procedures to address short-term challenges. - Adapts to Change: Views difficult situations and/or problems as opportunities for improvement; actively embraces change instead of emphasizing negative elements.

Position Qualifications:

Responsibilities:

Certifications:

LIC-Registered Nurse - Licensure-Others

Work Experience:

Relevant Work Experience

Experience Level:

Less than 1 year

Education:

Graduate of an approved discipline specific program

Vanderbilt Health recognizes that diversity is essential for excellence and innovation. We are committed to an inclusive environment where everyone has the chance to thrive and to the principles of equal opportunity and affirmative action. EOE/AA/Women/Minority/Vets/Disabled