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Yale University

Research university in New Haven, CT

Clinical Research Nurse 2

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeNew Haven, CT, USA$68k - $120.5k

About the Job

Requirements

  • Excellent clinical, analytical, and organizational skills, with demonstrated research nursing ability.
  • Ability to draft, proofread, and document complex items, with meticulous attention to detail.
  • Strong computer skills, including competency in Microsoft Office programs such as Word, Excel, and PowerPoint.
  • Ability to multitask, maintain confidentiality, and remain focused in a fast-paced environment.
  • Strong time-management and organizational skills.
  • Ability to interpret complex protocols; evaluate and assess subject suitability for study inclusion; obtain informed consent; determine patient eligibility; and coordinate patient enrollment.
  • 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 at least 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 indicate the ability to work with minimal supervision in a team environment.
  • Licensure as a Registered Nurse in Connecticut or eligibility for a Connecticut license.
  • As a healthcare worker, must meet pre-employment health requirements, including MMR and varicella vaccination or immunity, tuberculosis screening, COVID vaccination according to University policy, hepatitis B vaccination or immunity, and annual flu vaccination.
  • All candidates are subject to pre-employment background screening; offers are contingent on successful completion.

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 ICH/GCP, 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 research protocols; review Beacon order sets with the CRC before participant clinic visits; and pend orders for Investigator approval and signature.
  • Support Principal Investigator oversight by providing updates on protocol issues and obtaining signatures and clinical significance on laboratory reports, ECGs, adverse events, and other required documents.
  • Develop and participate in training for new protocols, including creating training materials, protocol-specific toolkits, and nursing in-service presentations; determine appropriate training delivery methods, timing, and frequency.
  • Provide direct patient care and clinical and non-clinical assessments, including electrocardiograms and administration of research instruments as required by 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 from Yale Cancer Center websites and professional presentations.
  • Provide patient education and medical information to study participants and families regarding medication dosage, administration, and side effects when appropriate.
  • Interpret protocols for medical and nursing staff, particularly regarding medication doses and safety issues associated with study drug or treatment administration.
  • Participate in monitoring visits and external audits, including sponsor and FDA 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 are preferred.
  • At least two years of clinical research nursing experience is strongly preferred.
  • Knowledge of Clinical Trials Management Systems is preferred.
  • ACRP/SOCRA or equivalent certification is preferred.
  • Oncology Nursing Society certification.

About the Company

Yale University

Research university in New Haven, CT

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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