Clinical Research Nurse Coordinator

5 days ago


Durham, North Carolina, United States Duke University Full time
Job Title:

Clinical Research Nurse Coordinator

Job Summary:

We are seeking a highly skilled Clinical Research Nurse Coordinator to join our team at Duke University. The successful candidate will be responsible for coordinating and managing clinical research studies, ensuring compliance with regulatory requirements, and providing exceptional patient care.

Key Responsibilities:
  • Participate in or lead day-to-day operations of clinical research studies conducted by principal investigator(s) at Duke Medicine.
  • Perform a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data.
  • Screen, schedule, consent, and collect adverse event information for participants in a variety of studies.
  • Maintain subject level documentation and prepare documents, equipment, or supplies for research visits.
  • Conduct and document visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments, and Standard Operating Procedures (SOPs) for all types of studies.
  • Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs.
  • Evaluate processes to identify issues related to recruitment and retention rates.
  • May provide training to junior personnel.
  • Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks.
  • Prepare for study monitoring or study audit visits and assist with addressing and correcting findings.
  • Develop or provide input for Institutional Review Board documents in a timely fashion.
  • Maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.
  • Assist with management of Investigational Products (IP) including arrival, storage, handling, requesting requisitions, inventory, reordering, drug accountability, reconciliation, and destruction.
  • Employ the required system for handling, dispensing, and documentation of IP for sponsored protocols.
  • Track IP compliance at the protocol-and subject level.
  • Collect, prepare, or process adverse event information per protocol, and provide input for adverse event reports.
  • May complete and submit Adverse Events Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms).
  • Have familiarity with intellectual property rights, inventions patents, and technologies.
  • As appropriate, understand regulations related to investigational products with sponsors.
  • Coordinate with Duke core services such as Investigational Drug Service (IDS), Biobank, etc.
  • Recognize the need for agreements (e.g., Material Transfer Agreements, Investigational New Drug Applications, etc.).
Requirements:
  • Graduation from an accredited BSN or Associate's Degree in Nursing or Nursing Diploma program.
  • Current or compact RN licensure in the state of North Carolina.
  • BLS required.
  • Twelve months of appropriate clinical nursing experience.
Preferred Qualifications:
  • Experience in clinical research or a related field.
  • Knowledge of regulatory requirements and guidelines for clinical research.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and as part of a team.
What We Offer:

Duke University is committed to creating a diverse and inclusive work environment. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

How to Apply:

To apply for this position, please submit your application through our website. We look forward to hearing from you



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