Yale University

Yale University

Research university in New Haven, CT

Clinical Research Nurse 2

Full-Time
$68k - $120.5k/yr
Mid
Bachelor's
New Haven, CT, USA
Hybrid

About the job

Requirements
  • Excellent clinical, analytical, and organizational skills with demonstrated research nursing ability.
  • Proven ability to draft, proofread, and document complex items.
  • Strong computer skills, including competency in Microsoft Office programs such as Word, Excel, and PowerPoint.
  • Proven ability to multitask, maintain confidentiality, and remain focused in a fast-paced environment.
  • Excellent time management and organizational skills.
  • Proven ability to interpret complex protocols, evaluate and assess subjects for study inclusion, obtain informed consent, determine patient eligibility, and coordinate patient enrollment.
  • Proven ability to coordinate patient care and communicate effectively.
  • Knowledge of Food and Drug Administration regulations, Good Clinical Practice guidelines, and other applicable federal regulations.
  • Graduate of an accredited nursing program and a minimum of three years of related nursing experience in a hospital, clinic, or similar healthcare setting, or three years of clinical research nurse experience, or an equivalent combination of education and experience.
  • Experience must demonstrate the ability to work with minimal supervision in a team environment.
  • Licensure as a Registered Nurse in the State of Connecticut or eligibility for a Connecticut license.
Responsibilities
  • Coordinate, implement, and evaluate all aspects of clinical trial conduct, including study initiation, execution and maintenance, completion, and administration for moderately to highly complex protocols.
  • Assist with study feasibility reviews.
  • Adhere to study protocols, maintain accurate documentation, recruit study participants, and ensure regulatory and protocol requirements and guidelines are met under International Council for Harmonisation/Good Clinical Practice, federal regulations, and institutional and sponsor requirements.
  • Identify instances of noncompliance and protocol deviations and report them to the appropriate parties.
  • Build, review, and approve accurate and complete order sets to ensure compliance with individual research protocols.
  • Review Beacon order sets with the Clinical Research Coordinator in anticipation of upcoming participant clinic visits and pend orders for routing to the Investigator for approval and signature.
  • Assist in ensuring Principal Investigator oversight by providing updates on protocol issues and obtaining signatures and clinical significance on lab reports, electrocardiograms, adverse events, and other required documents.
  • Develop and participate in training for new protocols, including creating training materials, protocol-specific toolkits, nursing in-service presentations, and other materials required by specific protocols.
  • Determine the appropriate training delivery mechanism, timing, and frequency.
  • Perform direct patient care, including clinical and non-clinical assessments, electrocardiograms, and administration of research instruments according to study protocols.
  • Advocate for patients and families to maintain the integrity of clinical research studies.
  • Serve as a clinical resource for triaging and addressing research-related inquiries generated from Yale Cancer Center websites and professional presentations.
  • Provide patient education and medical information to study participants and families concerning medication dosage, administration, and side effects when appropriate.
  • Serve as the front-line medical resource for interpreting protocols to medical and nursing staff, particularly concerning medication dosing and safety issues related to administering study drugs or treatments.
  • Participate in monitoring visits and external audits, including sponsor and Food and Drug Administration audits.
  • Track and report adverse events, serious adverse events, protocol waivers, deviations, and violations.
  • Perform other duties as assigned.
Desired Qualifications
  • Experience in an oncology research setting and experience working with federal regulations and Institutional Review Boards.
  • Minimum two years of clinical research nursing experience.
  • Knowledge of Clinical Trials Management Systems.
  • Association of Clinical Research Professionals or Society of Clinical Research Associates certification, or equivalent.
  • Oncology Nursing Society certification.

About the company

Yale University is a private research university in New Haven, Connecticut. It provides undergraduate, graduate, and professional education alongside research, scholarship, and public engagement.

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