Clinical Trial Research Nurse I
Vallejo, CaliforniaAt Kaiser Permanente our nurses are leaders, clinicians, researchers, innovators, and scientists who are contributing toward being an industry-leading voice for advancing evidence-based care. Whether supporting the patient directly in our hospitals or clinics, providing care at home, serving our patients through innovative virtual technology, or managing care delivery teams, Kaiser Permanente nurses utilize scientific evidence and our integrated care model to optimize the total health of our members and the communities we serve. We invite nurses who are passionate about nursing excellence, high-quality compassionate care delivery, professionalism, integrity, teamwork and patient and family centeredness to join our teams so that we can continue to sustain and build upon our culture of excellence.
- Job Type: Full-time
- Job Level: Individual Contributor
- Travel: No
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We’re looking for Nurse Leaders who possess the following traits.
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- Compassionate
- Flexible
- Leadership
- Socially Conscientious
- Trustworthy
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Medical, Vision & Dental
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Retirement Plans
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Educational Opportunities & Tuition Reimbursement
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Supportive Teams & Resources
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Career Growth & Development
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At Kaiser Permanente, we cultivate an environment of compassion, integrity, trust, and open communication that helps our teams do their best work. We believe that lifelong learning will expand our knowledge so we can better serve our patients. Our practice is rooted in research and evidence-based care. Our nurses reflect the rich diversity of our members and communities and provide culturally responsive and competent care that promotes understanding of our members needs and preferences. At Kaiser Permanente, nurses are highly skilled professionals who exemplify leadership, critical thinking, and collaborative problem solving and deliver the right care, at the right time, in the right setting.
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Clinical Trial Research Nurse I
Primary Location Vallejo, California
Worker Location Flexible
Facility Vallejo Medical Offices
Job Number 1271310 Date posted 04/16/2024
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Description:
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.
Job Summary:
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.
Essential Responsibilities:
- Compliance
- Support and comply with the Principles of Responsibility (Kaiser Permanente Code of Conduct). With guidance from PI, assist with ensuring compliance with KPNC IRB approved protocols.
- Adhere to Guideline for Good Clinical Practice (GCP), federal, state and local regulations, and KP policies and procedures. With direction, assist with any internal/external compliance monitoring and/or audits and inspections to protect research participants, assure operational effectiveness of the program, and to reduce risks to the organization.
- Study Implementation
- With guidance from PI, utilize nursing skills to coordinate research-related activities (e.g., scheduling study visits, assisting with nursing assessment of participants, adverse events, and data collection including laboratory and diagnostic studies).
- Perform nursing procedures required in the protocol, and report all protocol violations/deviations and averse events to the PI in a timely manner to ensure the health, safety and welfare of the participants.
- With supervision, utilize and document the nursing procedures to plan, deliver, and evaluate research care for non-complex medical conditions and, with appropriate assistance, for complex medical conditions.
- With supervision and direction by PI and/or designee, plan recruitment procedures for potential participants.
- Assist in the determination of eligibility of candidates for study participation.
- Assist in the identification and procurement of equipment and supplies needed to fulfill protocol requirements.
- With supervision, assist in the enrollment of subjects into the trial (screening, randomization, data collection) and any study-related procedures as required by protocol.
- With direction from PI, continuously assess participants to ensure continued eligibility for participation in the study.
- Participate in the ongoing informed consent process with the PI to ensure that research participants and their families have their questions answered and understand the patient/participant Bill of Rights, consent form, and participants responsibilities in the study.
- With direction, communicate with participants throughout the study regarding pertinent updated study information.
- Accurately and completely record information in source documents in a timely manner.
- With supervision, assist in the accurate and appropriate study test article management.
- Coordinate and perform packaging and shipping of protocol specimens to the Sponsor lab in accordance with IATA/DOT regulations and Sponsor shipping guidelines, if applicable.
- Within the nursing scope of practice, assist the PI with the care and evaluation of research participants.
- With direction, abstract data from source documentation onto case report forms (paper or electronic) in a timely manner.
- Assist with study completion, resolution of data queries, data lock, study closeout, and archiving of study files.
- Support the regulatory team in the maintenance and storage of critical documents required to be maintained and provided to the Sponsor during the conduct of the trial.
- Support the effective financial management of the clinical trial.
- Leadership and Communication
- With guidance from the PI, communicate with and educate the research participant about study activities and requirements, as needed.
- Collaboratively participate in study team meetings.
- With supervision, maintain ongoing communication with internal and external parties, Sponsor, PI, clinical trials administrative management, study participants, and KPNC Offices of Clinical Trial Compliance and Operations.
- If applicable and with supervision, coordinate IRB communications (e.g., new protocols, amendments, continuing review applications, protocol violations, and adverse events) in accordance with institutional and departmental policies and procedures.
- Education and Training
- With direction, participate in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development as a novice research nurse participating in the conduct of clinical trials.
- Work with an assigned mentor on a regular basis for training and resource questions. Attend KP site-initiated meetings for protocol training including Sponsor-initiated meetings, as requested.
- Participate as a member of the Clinical Trial Operations Team (CTOT) and attend meetings, as requested.
- Quality Improvement
- With direction, perform routine quality control activities and assist with quality improvement initiatives.
- Systems and Infrastructure
- Adhere to departmental policies and procedures to ensure confidentiality, privacy and security of clinical research interactions and participant information, and responsible use of operational research databases in compliance with KP policies. Adhere to departmental policies and procedures to support high-quality implementation and conduct of clinical trials, and assure maintenance of research activities and documentation in compliance with the protocols and KP policies and procedures.
- Assist others with the maintenance of systems and resources for the effective communication and submission of required documentation to the IRB.
- Participate with PI and KFRI to identify and prioritize the development of clinical trials systems and infrastructure to maintain research quality and compliance at clinical trial sites.
- Staff Supervision
- No supervisory responsibilities. May oversee specific tasks of non-licensed clinical trial research staff and provide feedback to supervisor.
- General
- Perform job functions according to the factors listed below under Job Criteria.
- Other duties as assigned by appropriate management.
- Kaiser Permanente conducts compensation reviews of positions on a routine basis. At any time, Kaiser Permanente reserves the right to reevaluate and change job descriptions, or to change such positions from salaried to hourly pay status. Such changes are generally implemented only after notice is given to affected employees to our members, and to purchasers, contracted providers and vendors.
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 (Bachelors 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
- Clinical Research Professional Certificate within 12 months of hire from Society of Clinical Research Associates OR Clinical Research Associate Certificate within 12 months of hire from The Association of Clinical Research Professionals
- Registered Nurse License (California)
- Basic Life Support
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.
Primary Location: California,Vallejo,Vallejo Medical Offices
Scheduled Weekly Hours: 40
Shift: Day
Workdays: Tue, Wed, Thu, Fri
Working Hours Start: 07:00 AM
Working Hours End: 05:30 PM
Job Schedule: Full-time
Job Type: Standard
Worker Location: Flexible
Employee Status: Regular
Employee Group/Union Affiliation: NUE-NCAL-09|NUE|Non Union Employee
Job Level: Individual Contributor
Department: Oakland Reg - 2000 Broadway - Rsrch-Invstgtr Staffg Mdl Dept - 0201
Pay Range: $151900 - $196570 / year
The ranges posted above reflect the location in the job posting. The salary range may vary if you reside in a different location or state than the location posted.
Travel: No
Flexible: Work location is on-site at a KP location, with the flexibility to work from home.
Worker location must align with Kaiser Permanente's Authorized States policy.
At Kaiser Permanente, equity, inclusion and diversity are inextricably linked to our mission, and we aim to make it a part of everything we do. We know that having a diverse and inclusive workforce makes Kaiser Permanente a better place to receive health care, a more supportive partner in our communities we serve, and a more fulfilling place to work. Working at Kaiser Permanente means that you agree to and abide by our commitment to equity and our expectation that we all work together to create an inclusive work environment focused on a sense of belonging and wellbeing.
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. Submit Interest
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. Submit Interest
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