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:
This position is with the VISPR Program, formerly called the Halasa/Chappell Lab, jointly led by Drs Natasha Halasa and Jim Chappell, 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.
This position is responsible for coordinating the approval processes and conduct of research protocols, such that the integrity and quality of the clinical/translational research is maintained, and the research is conducted in accordance within all policies, with some guidance.
Under the guidance of the Principal Investigator, the Nurse Practitioner is responsible for assisting in the design of the clinical research, 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/sponsor regulations and guidelines and Vanderbilt Policy and Procedure. The NP independently plans and implements recruitment procedures for potential participants, manages enrollment of the trial from screening, and performs physical exams, 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, DSMP and other research-related entities.
KEY RESPONSIBILITIES
Clinical Trials Management - 40%
- Perform physical exams on clinical research participants
- Oversee vaccine trials, including for young children and immunocompromised hosts
- Knowledge and understanding of the management and implementation of clinical trial operations
- Capability to understand, implement, and follow a clinical study protocol and ability to conduct multiple studies, mostly independently (able to identify when training is needed to safely and accurately perform or assess required procedures. Problem solves when needed to acquire or deliver such training).
- Participate in the determination of eligible candidates for study participation. Strive to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation.
- Digest complex clinical information to determine if documentation is accurate, complete, and ensure procedures contain appropriate safeguards. Understand standard of care versus research and continually assess need for additional protections for the protection of research participants and the appropriateness of research data.
- Assess and evaluate potential participants' pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical trials
- Utilize nursing skills to complete all 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 use and document 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, seeking assistance when needed
- Perform procedures for research as they are described in the protocol, deviating from the protocol only when a subject's safety is at risk and reporting all deviations to the Principal Investigator who will determine if a protocol amendment or other safety assessment is required
- Participate in and maintain professional certifications, licensure and credentialing as required of nurses employed at Vanderbilt (e.g., CPR certification)
Project and Regulator Management - 30%
- Knowledge and understanding of policies, procedures, and regulations governing human subjects research. Proficiently prepare and process 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
- Has expert knowledge and understanding of the Vanderbilt policies and regulations governing the protection of human subjects
- Function as a departmental resource regarding clinical trials operations e.g., the operations of the Vanderbilt Institutional Review Board (IRB) and its requirements for the protection of human subjects
- Maintain a clear understanding of the Federal regulations governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH guidelines, and HIPAA regulations
- Independently prepare and maintain critical documents required to be maintained and provided to the sponsor during and after the conduct of a clinical trial. Assist with study completion, data lock, study closeout and archiving of study files.
- Collaboratively participate in and direct study team meetings, as appropriate/as instructed by the PI
- Maintain open and positive communications with investigators, participants, co-workers, other departments and sponsors. Collaborate with other departments to seek solutions to global research concerns.
- Assist in budget and contract negotiation and facilitate interactions between sponsors and institutional departments, as requested by PI
- Serve as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, representatives of professional organizations, participant advocates, and members of the public responsible for, or concerned about, protections for human participants of research
- Participate in the ongoing informed consent process, ensuring that human subjects clearly understand what is expected of and from them in the course of participating in a clinical trial
- Utilize knowledge of disease processes to observe and report adverse events in a timely and accurate manner to the Principal Investigator, DSMB and all regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol, policies and procedures, and regulations
TECHNICAL CAPABILITIES
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:
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 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-Licensed Nurse Practitioner - Tennessee
Work Experience:
Relevant Work Experience
Experience Level:
Less than 1 year
Education:
Master's
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
#J-18808-Ljbffr
