Research Nurse - Days
Company: WellSpan Health
Location: York
Posted on: November 19, 2023
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Job Description:
SummaryFull Time (80 Hours Biweekly)DaysJob Description:Under
general supervision, coordinates clinical research activities and
compliance to study requirements, and patient and staff
considerations relative to specific clinical trials and/or studies.
Monitors the clinical course and collection of research data for
patients in clinical trials. Assists the medical investigators in
achieving the objectives of clinical research studies, and supports
ongoing patient management approaches in the designated
disease/treatment area(s). Considers nursing implications in areas
of staff and patient educational needs, staff resources, and
research objectives. Acts as a resource for clinical and support
staff involved in the care of patients enrolled in appropriate
studies. Coordinates and performs nursing responsibilities in
specialty area(s) for clinical research patients.Duties and
ResponsibilitiesEssential Accountabilities:Participates in the
review of research protocols and assesses the appropriateness,
feasibility and resource requirements for implementation. Develops
plans as needed to address patient care and staffing
requirements.Assists investigators in evaluating the quality of
care and compliance to protocol requirements. Initiates corrective
actionas needed. Ensures that there is documented Institutional
Review Board approval for protocols and consent forms priorto
patient enrollment.Maintains an excellent working knowledge of all
protocols. Develops and conducts formal and informal education
toinform clinical and other staff of implications of protocol
procedures. Distributes protocol and patient information in atimely
manner.Ensures that patient pretreatment, eligibility and informed
consent documentation requirements are met prior to
patientenrollment/registration in a research study. Registers and
accomplishes randomization of patients enrolled in researchstudies.
Documents record of institutional patient registration.Collaborates
with nursing staff in assessing, planning, implementing and
evaluating the nursing care of the patientpopulation specific to
clinical research studies. Monitors dosage modifications and
treatment calculations and assessespatients for toxicity and
response.Evaluates and identifies potentially eligible protocol
patients, and verifies according to protocol requirements.
Providesdirect patient education regarding protocol participation,
and provides additional information as appropriate. Ensures
theintegrity of the informed consent process and assists in
obtaining informed consent from patients. Works with internaland
external registration and scheduling personnel as appropriate to
facilitate study entry.Coordinates, observes and/or records data
for protocol therapy. Actively participates in assessing patients
for toxicity and response using chart review and physical
assessment skills and communication with physicians and
nurses.Adheres to all protocol requirements to ensure validity of
clinical research patient data. Submits complete and accurate forms
and materials to external agencies as required in accordance with
protocol requirements.Coordinates protocol-related patient
activities to ensure protocol compliance and optimal patient
scheduling. Designs and compiles forms and educational materials to
aid physicians and staff in complying with protocol requirements
including tests and follow up visits.Monitors and facilitates
necessary documentation in the conduct of clinical research
studies. Regularly reviews protocolstudy forms for accuracy and
compliance to protocol standards. Performs consistency checks,
edits for errors, andmonitors timeliness of data submission.
Identifies system inadequacies and augments the system as
necessary.Prepares and/or processes adverse event reports on
protocol patients and submits these to the principal investigator
and appropriate agencies. Alerts investigators and appropriate
personnel of communications received regarding adverse events or
drug reaction reports.Oversees the receipt, secure storage and
dispensing of medications provided for protocol patients. Reviews
investigational drug logs and inventories to assure that
appropriate documentation is maintained and federal guidelines are
met.Coordinates all site visit audits. Gathers records and other
necessary materials required for audits. Reviews records with all
site visit teams and responds to audit reports in a timely
manner.Maintains cooperative relations with clinical research
participants. Acts as a liaison between national cooperative
groups, institutional investigators, staff and affiliate
groups.Triages patient calls, attending to or resolving problems
and answering questions.Suggests improved methods for accomplishing
research goals.NonEssential Accountabilities:Attends meetings as
required.Performs other related duties as identified.Common
Expectations:Is knowledgeable of and complies with institutional
research policies, procedures and guidelines. With the oversight of
the Director of Research/Human Subjects Protection Administrator,
has knowledge of and complies with governmental regulations
regarding responsible conduct of research, research ethics and
integrity and protection of the safety and welfare of human
subjects (i.e., DHHS, FDA and IRB research regulations, HIPAA
privacy and research regulations and others as applicable, such as
those governing specimen banks, genetic research, etc.). Instructs
less experienced personnel and advises others to insure that
research is conducted safely and in compliance with the above.
Reports apparent or potential problems to the Director of
Research/Human Subject Protection Administrator and the appropriate
Service Line Leader.Demonstrates knowledge of the principles of
growth and development over the life span of the assigned
patientpopulation. Assesses and interprets patient age specific
data and provides appropriate, age specific treatment.
Providesdirect patient care to assigned patient age
group(s).Provides outstanding service to all customers; fosters
teamwork; and practices fiscal responsibility through
improvementand innovation.QualificationsNotes:Other combinations of
formal education, training and experience may be considered.Minimum
Experience:2 - 3 yearsMinimum Education:Bachelor's DegreeMinimum
Field Of Expertise:Nursing; medical research; clinical
trialsPreferred Education:Master's DegreeRequired
Certification:Registration and current RN license in PA; CPR
certificationPreferred Certification:Appropriate RN specialty
certification; National certification, clinical
research/trialsPhysical Demands:Occasional prolonged
standing/walking
Keywords: WellSpan Health, Harrisburg , Research Nurse - Days, Healthcare , York, Pennsylvania
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