Clinical Trial Research Nurse I, So. San Francisco, Oncology

Company: Kaiser
Location: Hayward
Posted on: March 17, 2023

Job Description:

#LI-DP1The 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. -Essential Functions:--- 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.Basic Qualifications:Experience- 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).Education- Minimum of a diploma from an accredited nursing school required.- High School Diploma or General Education Development (GED) required.License, Certification, Registration- N/A -Additional Requirements:- 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. -Preferred Qualifications:- Clinical trials research experience preferred.Job Schedule: Job Category: Nursing Licensed & Nurse Practitioners

Keywords: Kaiser, Hayward , Clinical Trial Research Nurse I, So. San Francisco, Oncology, Healthcare , Hayward, California