Research Nurse Specialist II - Nashville, TN, United States - Vanderbilt University Medical Center

Description

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:
Allergy, Pulmonary and Critica


Job Summary:

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 Procedures.

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.

Our mission is to promote multidisciplinary science and training among investigators across fields and career stages to drive clinically meaningful advances in our understanding of sepsis and critical illness.

The major focus of this laboratory is to define mechanisms of lung and other organ injury in critical illnesses such as sepsis.

We utilize translational methods including primary human cells, animal models, and the ex vivo human lung.

This is a Part-Time, Weekend position.


Department Summary:
Welcome to the Division of Allergy, Pulmonary and Critical Care Medicine at Vanderbilt University Medical Center.


Our mission is to:

• Deliver worldclass clinical care to patients with allergic diseases, pulmonary

conditions, and critical illness through employing a collaborative, multi-disciplinary approach

• Lead in the development of cuttingedge, patientfocused research that

extends from basic discoveries to clinical implementation

• Provide stateoftheart education and training to inspire and nurture the next

generation of leaders in allergy and immunology, pulmonary and critical care

medicine, and interventional pulmonology

.


KEY RESPONSIBILITIES

• 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 Page 2 of 3 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.

TECHNICAL CAPABILITIES

• Evidence-Based Practice (Novice): Possesses sufficient fundamental proficiency to successfully search for evidence to answer clinical questions. Generally works under the direction of others while accomplishing assignments.
• Care Planning (Novice): Demonstrates ability to anticipate resource needs, identify distinct tasks, set priorities, schedule activities, meet deadlines, and organize work within areas of direct responsibility. Competently handles multiple assignments often simultaneously by prioritizing work into manageable and measurable units. Ability to adapt to changes to patient care and area needs with minimal disruption and loss of productivity. Follows up to assure problems and issues are resolved.
• Nursing Patient Education (Novice): Possesses sufficient fundamental proficiency in providing patient education in practical applications of moderate difficulty.
• Nursing Patient Assessment & Evaluation (Novice): Possesses sufficient fundamental proficiency to successfully demonstrate the ability to assess and evaluate patients in practical applications of moderate difficulty. Conducts primary care patient interviews and physical examinations. Demonstrates sufficient acumen to recognize problems, ask questions and to contact the patient's primary care provider and other members of the healthcare team. Has experience in gathering pertinent clinical data that aid in referral, treatment, or other primary care pathways.
• Regulatory Compliance (Novice): 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 (Novice): 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 :
• 
  Benefits :
• 
  Our Nursing Philosophy :
• 
  Our Nursing Leadership :
• 
  Shared Governance :
• 
  Education& Professional Development :
• 
  Life In Nashville :
• 
  VUMC Nursing :

Core Accountabilities:

Organizational Impact:

Executes job responsibilities with the understanding of how output would affect and impact other areas related to own job area/team with occasional guidance.

Problem Solving/ Complexity of work:
Analyzes moderately complex problems using technical experience and judgment


Breadth of Knowledge:
Has expanded knowledge gained through experience within a professional area


Team Interaction:
Provides informal guidance and support to team members.


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:
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