Clinical Trials Research Nurse I, Santa Clara, Oncology
Location: Santa Clara
Posted on: November 26, 2022
The Clinical Trial Nurse I (CTN-I) is a novice level position
which, under the guidance & supervision of the Principal
Investigator (PI) & clinical trials admin Mgmt, assists in ensuring
that the integrity & quality of the clinical trial(s) are
maintained & conducted in accordance w/Fed, state & local
regulations, Institutional Review Board (IRB) approvals, & KP
policies & procedures. W/direction from the PI, this position
coordinates research activities as outlined in the Major
Responsibilities below. This position is also responsible for
protecting the health, safety, & welfare of research participants.
- Compliance: Support & comply w/the Principles of Responsibility
(KP Code of Conduct). W/ guidance from PI, assist w/ ensuring
compliance w/KPNC IRB approved protocols.
- Adhere to Guideline for Good Clinical Practice (GCP), federal,
state & local regulations, & KP policies & procedures. W/direction,
assist w/any internal/external compliance monitoring &/or
audits & inspections to protect research participants, assure
operational effectiveness of the program, & to reduce risks to the
- Study Implementation: W/guidance from PI, utilize nursing skills
to coordinate research-related activities (e.g., scheduling study
visits, assisting w/nursing assessment of participants, adverse
events, & data collection including laboratory & diagnostic
- Perform nursing procedures required in the protocol, & report all
protocol violations/deviations & averse events to the PI in a
timely manner to ensure the health, safety & welfare of the
- W/ supervision, utilize & Doc the nursing procedures to plan,
deliver, & evaluate research care for non-complex medical
conditions &, w/appropriate assistance, for complex medical
- W/supervision & direction by PI &/or designee, plan
recruitment procedures for potential participants.
- Assist in the determination of eligibility of candidates for
- Assist in the identification & procurement of equipment &
supplies needed to fulfill protocol requirements.
- W/supervision, assist in the enrollment of subjects into the
trial (screening, randomization, data collection) & any
study-related procedures as required by protocol.
- W/direction from PI, continuously assess participants to ensure
continued eligibility for participation in the study.
- Participate in the ongoing informed consent process w/the PI to
ensure that research participants & their families have their
questions answered & understand the patient/participant Bill of
Rights, consent form, & participant's responsibilities in the
- W/direction, communicate w/participants throughout the study
regarding pertinent updated study info.
- Accurately & completely record info in source Docs in a timely
- W/ supervision, assist in the accurate & appropriate study test
- Coordinate & perform packaging & shipping of protocol specimens
to the Sponsor lab in accordance w/ IATA/DOT regulations & -
Sponsor shipping guidelines, if applicable.
- W/in the nursing scope of practice, assist the PI w/the care &
evaluation of research participants.
- W/direction, abstract data from source documentation onto case
report forms (paper or electronic) in a timely manner.
- Assist w/study completion, resolution of data queries, data lock,
study closeout, & archiving of study files.
- Support the regulatory team in the maintenance & storage of
critical Docs required to be maintained & provided to the Sponsor
during the conduct of the trial.
- Support the effective financial management of the clinical
- This job description is not all encompassing.Basic
- Minimum two (2) years of clinical nursing experience in a
hospital, clinic or similar health care setting within the last
three (3) years required (Bachelor's degree may be substituted for
one (1) year work experience).
- Minimum of a diploma from an accredited nursing school
- High School Diploma or General Education Development (GED)
License, Certification, Registration
- Must be proficient in electronic health systems and databases
used in research environment, or willingness to learn and
demonstrate proficiency within six months of hire.
- Demonstrate effective written, verbal, and interpersonal
- Attention to detail and accuracy.
- Ability to manage multiple tasks with time deadlines.
- Demonstrate prioritization and organizational skills.
- Proficient in medical terminology.
- Demonstrate basic drug calculation skills.
- Demonstrate problem-solving skills.
- Demonstrate nursing competency skills per scope of practice
(i.e., phlebotomy, performing vital signs, nursing assessments,
urine dipstick reading, pregnancy test reading, performing EKG,
etc.) with certification if applicable.
- Other (specific to relevant therapeutic area).
- Knowledge of GCP, federal, state, and local regulations including
HIPAA and KP policies and procedures.
- Must be able to work in a Labor/Management Partnership
- Clinical trials research experience preferred.Job Schedule: Job
Category: Nursing Licensed & Nurse Practitioners
Keywords: Kaiser, Santa Clara , Clinical Trials Research Nurse I, Santa Clara, Oncology, Healthcare , Santa Clara, California
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