Clinical Trials Research Nurse I, San Leandro
Employment Type: Full-Time
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 organization.
* 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 studies).
* 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 participants.
* W/ supervision, utilize & Doc the nursing procedures to plan, deliver, & evaluate research care for non-complex medical conditions &, w/appropriate assistance, for complex medical conditions.
* W/supervision & direction by PI &/or designee, plan recruitment procedures for potential participants.
* Assist in the determination of eligibility of candidates for study participation.
* 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 study.
* W/direction, communicate w/participants throughout the study regarding pertinent updated study info.
* Accurately & completely record info in source Docs in a timely manner.
* W/ supervision, assist in the accurate & appropriate study test article management.
* 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 trial.
* This job description is not all encompassing.
* 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 required.
* High School Diploma or General Education Development (GED) required.
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 communication skills.
* 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 environment.
* Clinical trials research experience preferred.
Additional Preferred Qualifications:
* Responsible for assisting in the informed consent process, screening potential patients for adult oncology clinical trials; assessing treatment patients for toxicities; dose modifications, and serious adverse events; patient/family/medical/nursing staff education; assist physicians' in tumor assessments of subjects as per protocol; assist in accurate data collection, and ordering all protocol requirements and obtaining results; preparation, collection, and shipment of all required protocol specimens. Travel to other sites as needed for research activity/patient coverage.
Primary Location: California,San Leandro,San Leandro Medical Center Scheduled Weekly Hours: 40 Shift: Day Workdays: Mon, Tue, Wed, Thu, Fri Working Hours Start: 8:30 AM Working Hours End: 5:00 PM Job Schedule: Full-time Job Type: Standard Employee Status: Regular Employee Group/Union Affiliation: NUE-NCAL-09|NUE|Non Union Employee Job Level: Individual Contributor Job Category: Nursing Licensed Department: Div of Research Travel: Yes, 5 % of the Time Kaiser Permanente is an equal opportunity employer committed to a diverse and inclusive workforce. Applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), age, sexual orientation, national origin, marital status, parental status, ancestry, disability, gender identity, veteran status, genetic information, other distinguishing characteristics of diversity and inclusion, or any other protected status.
External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with federal and state laws, as well as applicable local ordinances, including but not limited to the San Francisco and Los Angeles Fair Chance Ordinances.
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