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Clinical Trial Research Nurse ILocation: Oakland, CA Additional Locations:
Job Number: 791727 Date posted: 05/15/2019
The Clinical Trial Nurse I (CTN-I) is a novice level position which, under the guidance and supervision of the Principal Investigator (PI) and clinical trials administrative management, assists in ensuring that the integrity and quality of the clinical trial(s) are maintained and conducted in accordance with federal, state and local regulations, Institutional Review Board (IRB) approvals, and Kaiser Permanente (KP) policies and procedures. With 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, and welfare of research participants.
- Compliance:Support & comply w/ the Principles of Responsibility (Kaiser Permanente 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 & document 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 information. Accurately & completely record information in source documents in a timely manner. W/ supervision, assist in the accurate & appropriate study test article mgmt. 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.
- This job description is not all encompassing.
- This study aims to identify the optimal method to recognize, risk stratify, and provide follow-up care for individuals at risk of hereditary cancer (breast, ovarian, and colon). We will evaluate three methods for identifying and risk-stratifying individuals at risk of hereditary cancer and providing post-risk stratification longitudinal care: 1) Physician-based collection/interpretation of family history and provision of longitudinal care (usual care); 2) Patient-completion of online validated clinical prediction rules that estimate risk of developing cancer or harboring a cancer-causing mutation, with subsequent care coordination by a genetic counselor/nurse practitioner team; 3) Patient-completion online of a 3-generation family pedigree with post-risk stratification care coordination by a genetic counselor/nurse practitioner team.
- 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.
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.
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.
About Nursing & Physician Assistant Careers
Through professional practice and leadership, nurses at Kaiser Permanente continually advance the art and science of nursing. But we recognize that what we do is more than clinical practice. We believe that every interaction — whether it is with a patient, a colleague, a physician, or anyone else — has the potential to be extraordinary. And we find that approaching our daily routine with this in mind gives each and every action new meaning and allows us to focus on the moment, empowering us to deliver expert care.
No matter where you are in your nursing career, the size and scope of our organization means you have the resources, technology, tools, and support you need to make a lasting impact.
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Physician assistants play a powerful and important role in delivering high-quality, informative care. Working directly with patients, their families, colleagues, and supervising physicians, they are vital in defining the overall care experience.
Being a physician assistant at Kaiser Permanente is centered on promoting a healing environment — one that maintains a caring, comforting practice while honoring the unity of the whole patient: mind, body, and spirit.
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