AddressThe Clinical TrialNurse 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.
