Tufts CTSI seeks a Clinical Nurse Leader that will be part of a team to develop, implement, manage, and administer pediatric and adult clinical research trial protocols in the CTRC. The Clinical Nurse Leader will interface with inpatient and outpatient facilities, Departments, and personnel to assure a collaborative environment and high quality outcomes.
The Clinical Nurse Leader will assist the planning and delivery of participant evaluations in the CTRC, use nursing process and adhere to standards of nursing practice and will translate the philosophy, objectives, policies and procedures of the hospital and nursing services into effective action.
Ensures a culture of patient safety in the CTRC; teaches and oversees implementation of best practices that promote a focus on safety in a clinical research environment.
Monitors and ensures excellence in the clinical practice of nursing, research study coordination, and the
delivery of patient care; assures standards of care are consistently achieved in the CTRC.
Develops and monitors systems that promote and support nursing and clinical coordinator practice.
Interacts with staff nurses and clinical coordinators for the purpose of assessing the care and services provided, as well as the capabilities to provide care and services in changing circumstances.
Demonstrates clinical research expertise, integrating nursing theory and practice. Employs evidence- based practice in decision-making and patient care.
Uses the nursing process for the delivery and management of participant evaluations across the continuum of care appropriate to the developmental age of the patient population.
Provides consultation to participants, family members, and nursing staff as issues arise regarding the participant's experience.
Uses the quality assurance and performance improvement process to assess the response to nursing care from participants, families, and others.
Uses clinical skills to provide ongoing assessment and evaluation of nursing care.
Coordinates and directs participant evaluations to ensure participants' needs are met and hospital policy is followed.
Maintains open communication with managers whose departments provide support services to the clinical area in order to ensure the appropriate level of service at all times.
Evaluates and communicates to supervisor regarding changing needs of the unit, including staffing requirements.
Collaborates with other members of the unit management team in developing practice guidelines, competencies, and unit specific procedures.
Conducts participant evaluations, data collection, and specimen collection.
Supports CTRC clinical staff in the execution of delegated study activities
Ensures that research participants receive proper instruction that fosters compliance with the study protocol.
Management of the Environment:
Reviews proposed research protocols (phase I through phase IV) with Principal Investigators (PIs) and the CTRC Scientific Director and Associate Director, to assess feasibility; recommends modifications intended to facilitate successful conduct of studies.
Prepares, maintains and reviews study documentation. Prepares and maintains standard operating procedures and Manual of Operations for the unit.
Assists in preparing study budgets, assigns team members to studies.
Provides guidance to satellite sites and other Tufts Medical Center study coordinators to ensure patient safety, compliance with policies, and study objectives.
Ensures that study data and staff activities are recorded in an accurate and timely fashion.
Provides CTSI Finance Office with accurate and up-to-date information on a monthly basis to facilitate the billing process.
Communicates with Clinical Engineering pursuant to the intake and maintenance of equipment, including documentation of service and calibration records
Monitors and documents specimen storage conditions and manages unit response to temperature excursions and equipment malfunctions
Maintains documentation related to specimen intake and short/long term stored specimen inventory
Management of short and long term study records
Communicates and consistently supports the philosophy and goals of the unit, department and hospital.
Supports the orientation and preceptor programs.
Assists in the development and implementation plan of performance improvement activities.
Assists in developing mechanisms for data collection related to quality indicators.
Promotes staff participation in unit and hospital committees/task forces.
Delegates appropriately to others in accordance with job description and competency level.
Supports the ongoing development of staff through coaching, mentoring, and role modeling.
Collaborates with other members of leadership team in providing appropriate educational opportunities for licensed and unlicensed personnel.
Participates in and provides leadership to departmental and hospital committees as requested.
Assists in the development of practice initiatives through unit-based group activities.
Enhances own professional growth and development through participation in educational programs, keeping current with literature, inservice meetings, and workshops.
Bachelor's degree in Nursing required. Master's degree in a health- related field, or other field with significant health-related course work desired.
Current Massachusetts Registered Nurse license and BLS Certification is required.
4-5 years of progressively responsible work experience in patient care or clinical research, preferably in an academic medical center environment.
Experience conducting pediatric clinical studies highly preferred.
Experience with inpatient and outpatient clinical research.
Knowledge of Clinical Research methodology, Good Clinical Practice (GCP), regulatory requirements, and budgeting processes for clinical research studies.
Excellent interpersonal skills for effective engagement with clinicians, research participants, administrators, auxiliary personnel, regulators, and sponsors.
Strong quantitative and analytical skills to collect and interpret data and prepare reports; meticulous attention to detail.
Ability to work independently, design and manage projects with excellent follow through.
Excellent organizational and program management skills to effectively conduct a large portfolio of diverse clinical studies.
Expertise in the nursing process; professional judgment and decision- making; planning and providing nursing care in a research setting; and knowledge of the biomedical research process.
Possesses and applies the skills and knowledge necessary to provide care to patients throughout their participation in clinical trials, with consideration of aging processes, human development stages, and cultural patterns in each step of the research study process, consistent with unit guidelines and hospital policies, procedures, and protocols.
Demonstrated clinical competence in nursing practice.
Knowledge of best practices for handling blood borne pathogens, infection control, personal protection procedures.
Tufts Clinical and Translational Science Institute (CTSI) (https://www.tuftsctsi.org/
), one of more than 50 organizations supported by NIH Clinical and Translational Science Awards (CTSAs), was established in 2008 to transform the scientific research process through education, collaboration, and infrastructure services. Tufts CTSI accelerates translation of laboratory research into clinical use, medical practice, and health policy. An important part of Tufts CTSI is its Clinical and Translational Research Center (CTRC), which conducts a wide range of clinical studies, including Phase I studies, in research with participants across the lifespan in outpatient and inpatient settings. The CTRC offers an array of skills and resources to facilitate clinical research that aims to prevent, treat, or cure disease.