Clinical Trial Research Nurse II

Job Summary:

The Clinical Trial Nurse II (CTN-II) is a proficient 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.

The CTN-II works independently, assumes increased responsibilities, and requires periodic supervision. 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.


• Actively plan, prepare, and participate in any external and internal compliance monitoring and/or audits and inspections to protect research participants, assure operational effectiveness of the program, and reduce risks to the organization.


• Study Implementation
• In collaboration with PI, plan and implement recruitment procedures for potential participants.


• Participate in the determination of eligibility and recruitment of candidates for study participation.


• Identify and procure equipment and supplies needed to fulfill project requirements.


• With supervision, manage enrollment of participants into the trial (screening, randomization, follow-up, data collection), and any study-related procedures as required by protocol.


• With PI, assess participants to ensure continued eligibility for participation in the trial.


• Participate in the ongoing informed consent process with PI to ensure that research participants and their families have their questions answered and understand the patient/participant Bill of Rights, consent form, and prticipants responsibilities in the study.


• Cmmunicate with participants throughout the study regarding pertinent updated study information.


• 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).


• Within the nursing scope of practice, assist the PI with care and evaluation of research participants.


• Utilize knowledge of disease processes to observe and report adverse events and protocol violations/deviations in a timely and accurate manner to the PI and Sponsor to ensure the health, safety and welfare of the participant.


• With minimal supervision and adherence to scope of practice, utilize and document the nursing procedures to plan, deliver, and evaluate goal focused, individualized, safe, age-specific care as it relates to research participants with both non-complex and complex medical conditions.


• Independently communicate to appropriate resources to resolve research questions or issues.


• Assist in the accurate and appropriate study test article management, as appropriate.


• With minimal supervision, accurately record and abstract data from source documentation onto case report forms (paper or electronic) in a timely manner.


• Maintain accurate and timely source documentation.


• Assist with study completion, resolution of data queries, data lock, study closeout, and archiving of study files.


• With direction from PI and/or working with the Regional Regulatory Support staff, process new IRB research proposals, amendments, continuing review applications, protocol violations, and adverse events in accordance with KP and departmental policies and procedures and federal regulations, if applicable.


• 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.


• 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
• Communicate with and educate the research participant and other research support staff as needed.


• Maintain communication with internal and external parties, PI, Sponsor, clinical trials administrative management, KPNC IRB, study participants, and KPNC Offices of Clinical Trial Compliance and Operations on an ongoing basis.


• Education and Training
• Based on demonstrated clinical trial knowledge and skills, provide protocol specific education and training to appropriate personnel.


• Assist the research program in a quality improvement plan through ongoing assessment and evaluation reported to PI and management.


• Actively identify and participate in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development as a proficient research nurse participating in the conduct of clinical trials.


• 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
• Perform quality control activities and assist with quality improvement initiatives. ystems 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.


• 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.


• Maintain systems and resources for the effective communication and submission of required documentation to the IRB.


• Staff Supervision
• Potential supervision of other non-licensed and licensed clinical trials research staff.


• 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.