Clinical Trial Research Nurse I
3 weeks ago
**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.
- 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.
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 (speci
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