Clinical Research Nurse
Company: WCG
Location: Hackensack
Posted on: June 22, 2022
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Job Description:
General InformationLocation: Hackensack, NJOrganization: WCGJob
Type: Full time - Temporary (6 months)Summary Of
PositionDescription and RequirementsThe Charge Clinical Research
Nurse is responsible for providing guidance, training, and
coordination of the assigned oncology research divisions clinical
research nursing team. This individual plays a pivotal role in
coordinating and overseeing clinical operations of all assigned
Clinical Research Nurse and Clinical Trials and participates in
assessing, planning, implementing and evaluating Compliant Patient
Care in clinical research studies. The Charge Clinical Research
Nurse works under the general supervision of the Principal
Investigator(s) and Oncology Clinical Research
Administration.Vaccination RequirementTo be considered for
U.S.-based positions unless currently employed by WCG, where
permitted by applicable law (including any applicable reasonable
accommodation, medical or religious exemption), candidates must
have received or be willing to receive the COVID-19 and flu vaccine
by start date.Essential Requirements--- Graduate of a NLN/AACN
accredited program in nursing.--- BSN (Bachelor of Science in
Nursing)--- 3-5 years of progressive oncology nursing.--- 3-5 years
oncology clinical research nursing experience.--- Adheres to the
American Nurses Association standards.--- Strong attention to
detail and customer service focus is required.--- Excellent
communication, organizational, presentation, documentation, and
interpersonal skills are required.--- Ability to work
independently, or in a team, and handle multiple deadline-driven
tasks in a dynamic environment is essential.--- Proficiency in
Google Suite and Microsoft Office Suite (Word, Excel, and
PowerPoint), email (Outlook), and voicemail is required.Essential
Duties/Responsibilities--- Works together with and oversees all
assigned Clinical Research Nurse to:o Assure that all protocol
revisions, informed consents, continuing reviews, serious adverse
events are submitted to the appropriate IRB of record in a timely
manner.o Recruit and evaluate potential study patients, and works
with clinical research coordinator(s) to schedule required
appointments and interviews.o Identify the needs of the patient
population served and modify and deliver care that is specific to
those needs (i.e., age, culture, hearing and/or visually impaired,
etc.). This process includes communicating with the patient,
parent, and/or primary caregiver(s) at their level
(developmental/age, educational, literacy, etc.).o Review medical
records for potential study patients and ensures that medical
records include documentation of all laboratory test results and
procedures and progress of study patients, following guidelines set
forth by the protocol sponsors.o Instruct potential study patients,
designated caregiver, physicians, nurse clinicians and other
ancillary staff members involved in the care of the patient on
aspects of patient's care, available trials, treatments and side
effects.o Assist investigator with consent process assuring study
patients understand clinical trials and obtain written informed
consent.o Educate study patients concerning informed consent
procedures, HIPAA authorization.o Document study patient's medical
history including but not limited to past medical/surgical
treatments, significant medical conditions, and medication history
per protocol guidelines.o Perform nursing assessments and monitors
study patient's progress during clinical trials; Tracks study
patient's response by documenting on toxicity flow sheet,
medication flow sheet and nurses' progress notes.o Maintain
accurate, complete, up-to-date records on each patient
participating in a clinical trial protocol in all applicable
systems (i.e. electronic medical record, clinical trial management
system, departmental and protocol specific databases).o Evaluate
and develop study patient education materials and gives study
patient and/or designated caregiver instructions on drug
administration and other medical information; creates study
specific calendars for study patients.o Plan for study patient's
appropriate care under the direction of a physician or advanced
practice nurse.o Notify principal investigator of any adverse
events and serious adverse events, including evidence of drug
toxicity or unexpected side effects.o Report all serious adverse
events to sponsor and IRB of record according to established
timelines.o Perform and/or oversee a variety of clinical duties
that may include but not limited to: EKGs, processing/shipping of
blood serum, urine and communicate results to PI and/or APN.o
Together with the principal investigator, review and process all
Safety Reports (INDs, SUGARs) as per institutional policies and
procedures.--- Interacts with regulatory specialists and principal
investigators and sub-investigators on all regulatory issues and
changes within the protocol.--- In collaboration with the principal
investigator, clinical research coordinator, and clinical team,
participates in the review of studies for feasibility and evaluates
potential competition with other protocols prior to submitting
study.--- Reviews study with principal investigator and/or clinical
research coordinator to a budget outlining standard of care and
research costs. Finalizes budget draft with budget coordinator.---
Act as principal investigator's representative as appropriate. This
may include communicating with sponsors and their representatives,
the IRB and other medical personnel.--- Prepares and assists for
sponsor monitor site visits and ensures all supporting
documentation records are adequate and available for the visit;
Meets with monitor at least once during each monitor site visit and
resolves all issues found during visit.--- Assists the principal
investigator in preparing for publication. Works with analysts and
assists with queries related to data to evaluate the significance
of collected data.--- Provides education to all departments and
clinical areas where study is performed.--- Attends research
meetings and conferences as required.--- Coordinates and manages
the daily operations of the division in the abscess of
administration.--- Promotes safe patient care through assessing for
patient, family or team member issues.--- Plays an active role in
resolution of patient or team member problem; conflict
resolution--- Assures daily schedules within the division to
supports safe patient care and assists in maintaining appropriate
staffing within the division in compliance with acuity, etc.---
Interprets supports and communicates HMH & JTCC policies, standards
and procedures--- Efficiently identifies divisional problems and
develops solutions to review with Oncolgoy Research
Administration.--- Acts as a liaison for research nurses for
concerns between departments and facilities and collaborates with
the JTCC Management Team on inter and intra departmental issues
that may occur when dealing with other members of the
organization.--- Provides employee supervision to further enhance
quality care and gives feedback to staff--- Identifies patient care
issues and collaborates with the JTCC Management Team to initiate
change.--- Assumes special projects as assigned--- Lifts a minimum
of 5 lbs., pushes and pulls a minimum of 5 lbs. and stands a
minimum of 6 hours a day.--- Adheres to the standards identified in
the Medical Center's Organizational
Competencies.Experience/Skills--- Demonstrated ability to create
and follow research project-related supporting documents.--- Proven
ability to schedule and coordinate research activities as well as
work with a team to develop action items and other means to keep
projects moving along according to timeline.--- Demonstrated
ability to report on the status of project deliverables and draft
and submit project updates to the study sponsor.--- Strong clinical
and analytical skills. Proven ability to evaluate and assess
subject's suitability for inclusion into studies, obtain informed
consent, determine patient eligibility and coordinate patient
enrollment.--- Excellent time management and organizational skills.
Strong interpersonal skills with the proven ability to communicate
effectively.Preferred Education, Experience, Skills, Licenses or
Certifications--- BSN Preferred--- Mandatory education on human
subject research and GCP (CITI Training and Certification).---
Knowledge of clinical trials and the regulations (local, state, and
federal).--- Current valid NJ State Professional Registered Nurse
license.--- Certified Clinical Research Professional (CCRP) and/or
Certified Clinical Research Associate (CCRA) and/or Certified
Clinical Research Coordinator (CCRC).Physical DemandsThe physical
demands described here are representative of those that must be met
by an employee to successfully perform the essential functions of
this job. Reasonable accommodations may be made to individuals with
disabilities to perform the essential functions. While performing
the duties of this job, the employee is required to perform
sedentary work, which includes sitting for long periods and
occasionally required to lift 25lbs. Further guidance on physical
activities, requirements, visual acuity, and working conditions is
available in HR.WCG is proud to be an equal opportunity employer -
Qualified applicants will receive consideration for employment
without regard to race, color, national origin or ancestry,
religion or creed, sex, sexual orientation, gender identity, age,
marital status, disability, genetic information, citizenship,
veteran status, reprisal or any other legally recognized basis or
status protected by federal, state or local law.
Keywords: WCG, Hackensack , Clinical Research Nurse, Healthcare , Hackensack, New Jersey
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