Clinical Research Nurse II

2 days ago


New Haven, Connecticut, United States Yale University Full time
Job Summary

We are seeking a highly skilled Clinical Research Nurse II to join our team at Yale University. The successful candidate will be responsible for providing research services to patients participating in clinical trials within the Yale Cancer Center Clinical Trials Office.

Key Responsibilities
  • Coordinate, implement, and evaluate all aspects of clinical trial conduct, including study initiation, execution/maintenance, completion, and administration for moderately to highly complex protocols.
  • Assist study feasibility reviews and adhere to study protocol, maintaining accurate documentation, recruiting study participants, and ensuring regulatory and protocol requirements and guidelines are met.
  • Identify instances of noncompliance and deviations from protocol and report noncompliance and deviations to the appropriate parties.
  • Build, review, and approve accurate and complete order sets to ensure compliance with individual research protocols.
  • Assist 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.
  • Develop and participate in the delivery of training for new protocols, including the creation of training materials, protocol-specific tool kits, nursing in-service presentations, and others as required by specific protocols.
  • Perform direct patient care, including clinical and non-clinical assessments, and maintain the integrity of the clinical research study by striving to advocate for patients and families.
  • Provide patient education and medical information to study participants and families to ensure understanding of proper medication dosage, administration, and side effects, when appropriate.
  • Serve as a clinical resource for triaging and addressing research-related inquiries generated from YCC websites and professional presentations.
Requirements
  • Graduate of an accredited nursing program and minimum three (3) years of related nursing experience in a hospital, clinic, or similar healthcare setting required or 3 years of clinical research nurse experience, or equivalent combined experience, or the equivalent combination of education or experience.
  • Demonstrated experience must indicate the ability to work with minimal supervision in a team environment.
  • 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.
  • Proven ability to coordinate patient care and communicate effectively.
  • Knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations.
Preferred Qualifications
  • Demonstrated experience in oncology and research settings and experience working with Federal Regulations and IRBs is preferred.
  • Minimum two (2) years of clinical research nursing experience strongly preferred.
  • Knowledge of Clinical Trials Management Systems (CTMS).
What We Offer

Yale University offers a competitive salary and benefits package, as well as opportunities for professional growth and development.



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