Yale University
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Salary Range : $65,500.00 - $123,550.00
Overview
The Clinical Research Nurse II (CRN II) is responsible for providing research services to patients participating in clinical trials within the Yale Cancer Center Clinical Trials Office, while ensuring safe, compliant, efficient, and effective conduct of clinical trials. Key responsibilities include planning, tracking, and ensuring that the clinical activities for study participants are conducted in accordance with approved protocols. Responsibilities
Planning, tracking, and ensuring that the clinical activities for study participants are conducted in accordance with approved protocols. Managing and performing the clinical and operational aspects of moderately to highly complex protocols. Direct patient contact and managing patient care. Coordinating patient care and ensuring regulatory and protocol requirements and guidelines are met. Identifying instances of noncompliance and deviations from protocol and reporting noncompliance and deviations to the appropriate parties. Developing and participating in the delivery of training for new protocols. Performing direct patient care (clinical and non-clinical assessments) including, but not limited to electrocardiograms and administration of research instruments per study protocol requirements. Maintaining the integrity of the clinical research study by striving to advocate for patients and families. Providing patient education and medical information to study participants and families to ensure understanding of proper medication dosage, administration, and side effects, when appropriate. Serving as front line medical person in interpreting protocol to medical and nursing staff, particularly concerning dose medications and safety issues related to the administration of the study drug or treatment. Participating in monitoring visits, and external audits (e.g., sponsor, FDA) to ensure smooth and positive process and outcome. Tracking and reporting adverse events, serious adverse events, protocol waivers, deviations, and violations. Required Skills and Abilities
Excellent clinical, analytical, and organizational skills with demonstrated research nursing ability. Proven ability to interpret complex protocols and evaluate and assess subject’s suitability for inclusion into studies, obtain informed consent, determine patient eligibility, and coordinate patient enrollment. Proven ability to multi-task, maintain confidentiality and remain focused in a fast-paced environment. Excellent time management and organizational skills. Knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations. Preferred Education, Experience and Skills
Proven experience in oncology a research setting and experience working with Federal Regulations and IRBs is preferred. Minimum two (2) years of demonstrated clinical research nursing experience strongly preferred. Knowledge of Clinical Trials Management Systems (CTMS). Required Education and Experience
Graduate of an accredited nursing program and minimum three (3) years of related nursing experience in a hospital, clinic, or similar health care setting required or 3 years of clinical research nurse experience, or equivalent combined experience, or the equivalent combination of education or experience.
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The Clinical Research Nurse II (CRN II) is responsible for providing research services to patients participating in clinical trials within the Yale Cancer Center Clinical Trials Office, while ensuring safe, compliant, efficient, and effective conduct of clinical trials. Key responsibilities include planning, tracking, and ensuring that the clinical activities for study participants are conducted in accordance with approved protocols. Responsibilities
Planning, tracking, and ensuring that the clinical activities for study participants are conducted in accordance with approved protocols. Managing and performing the clinical and operational aspects of moderately to highly complex protocols. Direct patient contact and managing patient care. Coordinating patient care and ensuring regulatory and protocol requirements and guidelines are met. Identifying instances of noncompliance and deviations from protocol and reporting noncompliance and deviations to the appropriate parties. Developing and participating in the delivery of training for new protocols. Performing direct patient care (clinical and non-clinical assessments) including, but not limited to electrocardiograms and administration of research instruments per study protocol requirements. Maintaining the integrity of the clinical research study by striving to advocate for patients and families. Providing patient education and medical information to study participants and families to ensure understanding of proper medication dosage, administration, and side effects, when appropriate. Serving as front line medical person in interpreting protocol to medical and nursing staff, particularly concerning dose medications and safety issues related to the administration of the study drug or treatment. Participating in monitoring visits, and external audits (e.g., sponsor, FDA) to ensure smooth and positive process and outcome. Tracking and reporting adverse events, serious adverse events, protocol waivers, deviations, and violations. Required Skills and Abilities
Excellent clinical, analytical, and organizational skills with demonstrated research nursing ability. Proven ability to interpret complex protocols and evaluate and assess subject’s suitability for inclusion into studies, obtain informed consent, determine patient eligibility, and coordinate patient enrollment. Proven ability to multi-task, maintain confidentiality and remain focused in a fast-paced environment. Excellent time management and organizational skills. Knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations. Preferred Education, Experience and Skills
Proven experience in oncology a research setting and experience working with Federal Regulations and IRBs is preferred. Minimum two (2) years of demonstrated clinical research nursing experience strongly preferred. Knowledge of Clinical Trials Management Systems (CTMS). Required Education and Experience
Graduate of an accredited nursing program and minimum three (3) years of related nursing experience in a hospital, clinic, or similar health care setting required or 3 years of clinical research nurse experience, or equivalent combined experience, or the equivalent combination of education or experience.
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