Clinical Research Nurse 2
2 weeks ago
Provide research services to patients in clinical trials at Yale Cancer Center Clinical Trials Office, ensuring safe, compliant, efficient, and effective conduct of clinical trials.
Key responsibilities include planning, tracking, and ensuring clinical activities for study participants are conducted in accordance with approved protocols. These activities include patient screening, eligibility determination, registration, and other protocol and subject milestones.
- Coordinates, implements, and evaluates all aspects of clinical trial conduct, including study initiation, execution/maintenance, completion, and administration for moderately to highly complex protocols.
- Assists study feasibility reviews.
- Adheres to study protocol, maintains accurate documentation, recruits study participants, and ensures regulatory and protocol requirements and guidelines are met.
- Identifies instances of noncompliance and deviations from protocol and reports noncompliance and deviations to the appropriate parties.
- Builds, reviews, and approves accurate and complete order sets to ensure compliance with individual research protocols.
- Assists in ensuring Principal Investigator oversight by providing updates on protocol issues, obtaining signatures and clinical significance on lab reports, ECGs, adverse events, and other documents as required.
- Performs direct patient care, including clinical and non-clinical assessments, such as electrocardiograms and administration of research instruments per study protocol requirements.
- Maintains the integrity of the clinical research study by advocating for patients and families.
- Provides patient education and medical information to study participants and families to ensure understanding of proper medication dosage, administration, and side effects.
- Serves as a 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.
- Participates in monitoring visits and external audits to ensure smooth and positive process and outcome.
- Tracks and reports adverse events, serious adverse events, protocol waivers, deviations, and violations.
Requires a graduate degree in nursing and at least three years of related nursing experience, or equivalent combined experience, or the equivalent combination of education or experience.
Requires excellent clinical, analytical, and organizational skills, with demonstrated research nursing ability, and strong computer skills, including Microsoft Office programs.
Requires proven ability to interpret complex protocols, evaluate and assess subject suitability for inclusion into studies, obtain informed consent, determine patient eligibility, and coordinate patient enrollment.
Requires proven ability to multi-task, maintain confidentiality, and remain focused in a fast-paced environment, with excellent time management and organizational skills.
Requires knowledge of FDA regulations, GCP guidelines, and other applicable federal regulations.
Preferred experience in oncology research settings and working with Federal Regulations and IRBs, with minimum two years of clinical research nursing experience and knowledge of Clinical Trials Management Systems.
Requires licensure as a Registered Nurse in the State of Connecticut or Connecticut license eligibility.
Preferred ACRP/SOCRA certification and ONS certification.
Occasional weekend and evening hours required.
No drug screen or health screening required.
Background check required for all candidates for employment.
University policy is committed to affirmative action under law in employment of women, minority group members, individuals with disabilities, and protected veterans.
Yale University is a tobacco-free campus.
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New Haven, United States Yale University Full timeEssential Duties 1. Coordinates, implements, and evaluates all aspects of clinical trial conduct including study initiation, execution/maintenance, completion, and administration for moderately to highly complex protocols. 2. Assists study feasibility reviews. 3. Adheres to study protocol, maintains accurate documentation, recruits study participants, and...
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