Health eCareers
Clinical Trial Research Nurse I, Temporary, 40 hours, Daly City, Day
Health eCareers, Daly City, California, United States, 94013
Clinical Trial Research Nurse I, Temporary, 40 hours, Daly City, Day
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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, 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.
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 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 adverse events to the PI in a timely manner to ensure participant health, safety and welfare. 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 determination of eligibility of candidates for study participation. Assist in identification and procurement of equipment and supplies. With supervision, assist in enrollment of subjects into the trial (screening, randomization, data collection) and study-related procedures as required by protocol. With direction from PI, continuously assess participants to ensure continued eligibility. Participate in ongoing informed consent process with the PI. Communicate with participants regarding updated study information. Record information in source documents promptly. With supervision, assist in study test article management. Coordinate and perform packaging and shipping of protocol specimens to Sponsor lab per IATA/DOT regulations if applicable. Within nursing scope, assist the PI with care and evaluation of participants. With direction, abstract data from source documentation onto case report forms. Assist with study completion, resolution of data queries, data lock, study closeout, and archiving of study files. Support regulatory team in maintenance and storage of critical documents. Support 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. Collaboratively participate in study team meetings. Maintain ongoing communication with internal and external parties, Sponsor, PI, clinical trials administrative management, study participants, and KP Offices of Clinical Trial Compliance and Operations. If applicable and with supervision, coordinate IRB communications in accordance with institutional and departmental policies and procedures.
Education and Training: Participate in training and development activities to improve knowledge and performance as a novice research nurse. Work with an assigned mentor. Attend site-initiated and Sponsor-initiated protocol training. Participate as a member of the Clinical Trial Operations Team and attend meetings as requested.
Quality Improvement: Perform routine quality control activities and assist with quality improvement initiatives.
Systems and Infrastructure: Adhere to policies to ensure confidentiality, privacy and security of clinical research data. Support documentation and submission to the IRB and maintain research activities and documentation in compliance with protocols and KPIs. Assist with systems and resources for effective communication and submission of required documentation to the IRB. Participate in developing trials systems and infrastructure to maintain research quality and compliance.
Staff Supervision: No supervisory responsibilities. May oversee specific tasks of non-licensed clinical trial staff and provide feedback to supervisor.
General: Perform job functions and other duties as assigned.
Seniority level
Entry level
Employment type
Temporary, 40 hours/week
Job function
Health Care Provider
Industries
Staffing and Recruiting
#J-18808-Ljbffr
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, 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.
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 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 adverse events to the PI in a timely manner to ensure participant health, safety and welfare. 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 determination of eligibility of candidates for study participation. Assist in identification and procurement of equipment and supplies. With supervision, assist in enrollment of subjects into the trial (screening, randomization, data collection) and study-related procedures as required by protocol. With direction from PI, continuously assess participants to ensure continued eligibility. Participate in ongoing informed consent process with the PI. Communicate with participants regarding updated study information. Record information in source documents promptly. With supervision, assist in study test article management. Coordinate and perform packaging and shipping of protocol specimens to Sponsor lab per IATA/DOT regulations if applicable. Within nursing scope, assist the PI with care and evaluation of participants. With direction, abstract data from source documentation onto case report forms. Assist with study completion, resolution of data queries, data lock, study closeout, and archiving of study files. Support regulatory team in maintenance and storage of critical documents. Support 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. Collaboratively participate in study team meetings. Maintain ongoing communication with internal and external parties, Sponsor, PI, clinical trials administrative management, study participants, and KP Offices of Clinical Trial Compliance and Operations. If applicable and with supervision, coordinate IRB communications in accordance with institutional and departmental policies and procedures.
Education and Training: Participate in training and development activities to improve knowledge and performance as a novice research nurse. Work with an assigned mentor. Attend site-initiated and Sponsor-initiated protocol training. Participate as a member of the Clinical Trial Operations Team and attend meetings as requested.
Quality Improvement: Perform routine quality control activities and assist with quality improvement initiatives.
Systems and Infrastructure: Adhere to policies to ensure confidentiality, privacy and security of clinical research data. Support documentation and submission to the IRB and maintain research activities and documentation in compliance with protocols and KPIs. Assist with systems and resources for effective communication and submission of required documentation to the IRB. Participate in developing trials systems and infrastructure to maintain research quality and compliance.
Staff Supervision: No supervisory responsibilities. May oversee specific tasks of non-licensed clinical trial staff and provide feedback to supervisor.
General: Perform job functions and other duties as assigned.
Seniority level
Entry level
Employment type
Temporary, 40 hours/week
Job function
Health Care Provider
Industries
Staffing and Recruiting
#J-18808-Ljbffr