Full-Time

Clinical Research Nurse 2

Yale University

Yale University

Research university in New Haven, CT

Compensation Overview

$68k - $120.5k/yr

New Haven, CT, USA

Hybrid

Three days or fewer on-site per week is implied by the hybrid work model.

Bachelor's

Category
Medical, Clinical & Veterinary (1)
Biology & Biotech (1)
Required Skills
Microsoft Office
Word/Pages/Docs
Patient Education
Excel/Numbers/Sheets

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Requirements
  • Excellent clinical, analytical, and organizational skills with demonstrated research nursing ability.
  • The ability to draft, proofread, and document complex items accurately and meticulously.
  • Strong computer skills, including competency in Microsoft Office programs such as Word, Excel, and PowerPoint.
  • The ability to interpret complex protocols, evaluate subjects’ suitability for study inclusion, obtain informed consent, determine patient eligibility, and coordinate patient enrollment.
  • The ability to multitask, maintain confidentiality, and remain focused in a fast-paced environment.
  • Strong time-management and organizational skills.
  • The ability to coordinate patient care and communicate effectively.
  • Knowledge of Food and Drug Administration regulations, Good Clinical Practice guidelines, and other applicable federal regulations.
  • Graduation from 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.
  • The experience must demonstrate the ability to work with minimal supervision in a team environment.
  • Healthcare workers must meet pre-employment health requirements, including required vaccinations or immunity and tuberculosis screening.
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 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 investigator approval and signature.
  • Assist in ensuring Principal Investigator oversight by providing updates on protocol issues and obtaining signatures and clinical significance for laboratory 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 regarding medication dosage, administration, and side effects when appropriate.
  • Interpret protocols for medical and nursing staff, particularly regarding 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 assigned duties.
Desired Qualifications
  • Proven experience in oncology in a research setting.
  • Experience working with federal regulations and institutional review boards.
  • A minimum of two years of demonstrated clinical research nursing experience.
  • Knowledge of Clinical Trials Management Systems.

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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