Job Description
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 ensures regulatory and protocol requirements and guidelines are met per ICH/GCP, federal regulation, and institutional and sponsor requirements. 4. Identifies instances of noncompliance and deviations from protocol and reports noncompliance and deviations to the appropriate parties. 5. Builds, reviews, and approves accurate and complete order sets to ensure compliance with individual research protocols. Reviews Beacon order set with CRC in anticipation of upcoming participant's clinic visit. Pends orders for routing to Investigator for approval and signature. 6. 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. 7. Develops and participates in the delivery of training for new protocols, including the creation of training materials, protocol-specific tool kit, nursing in-service presentations and others as required by specific protocols. Determines the appropriate training delivery mechanism, timing, and frequency. 8. Performs direct patient care (clinical and non-clinical assessments) including, but not limited to electrocardiograms and administration of research instruments per study protocol requirements. 9. Maintains the integrity of the clinical research study by striving to advocate for patients and families. Serves as clinical resource for triaging and addressing research related inquiries generated from YCC websites and professional presentations. 10. Provides patient education and medical information to study participants and families to ensure understanding of proper medication dosage, administration, and side effects, when appropriate. 11. Serves 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. 12. Participates in monitoring visits, and external audits (e.g., sponsor, FDA) to ensure smooth and positive process and outcome. 13. Tracks and reports adverse events, serious adverse events, protocol waivers, deviations, and violations. 14. Performs other duties as assigned.
Required Skill/ability 1: Excellent clinical, analytical, and organizational skills with demonstrated research nursing ability. Proven ability to draft, proofread, and document items that are complex in nature. Proven ability to be meticulous with details. Strong computer skills required, including strong competency in Microsoft Office programs (Word, Excel, PowerPoint, etc.).
Required Skill/ability 2: 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.
Required Skill/ability 3: Proven ability to multi-task, maintain confidentiality and remain focused in a fast-paced environment. Excellent time management and organizational skills.
Required Skill/ability 4: Proven ability to coordinate patient care. Strong interpersonal skills with the proven ability to communicate effectively.
Required Skill/ability 5: Knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations.
Preferred Education: 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).
Work Week: Standard (M-F equal number of hours per day)
Posting Position Title: YCC Clinical Research Nurse 2
University Job Title: Clinical Research Nurse 2
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).
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. Experience must indicate the ability to work with minimal supervision in a team environment.
About Yale University
Yale University is an American private Ivy League research university located in New Haven, Connecticut. Founded in 1701 in the Colony of Connecticut, the university is the third-oldest institution of higher education in the United States.
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