CLINICAL RESEARCH NURSE COORDINATOR

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Clinical Research Nurse Coordinator- Trauma

Operations:

• Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties.
• Under supervision, assists with managing investigational products including arrival, storage, and handling (requisitions, inventory, and reordering).
• Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings.
• Maintains participant and study-level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR.
• Employs strategies to maintain retention rates. Evaluate processes to identify problems with retention.
• Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues.
• Screens and enrolls participants for all studies, including those that are complex in nature (e.g., procedural and interventional studies).
• Provides oversight and training in screening activities to multiple study teams.
• Develops or helps develop SOPs.
• Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens.
• Conducts activities for study visits in compliance with the protocol.
• Contributes to the effective facilitation of team meetings to achieve predetermined objectives. May lead multidisciplinary meetings with various stakeholders.
  
  

Ethics:

• Identifies all Adverse Events (AEs) and determines whether they are reportable.
• Collaborates with the Principal Investigator (PI) to determine AE attributes, including relatedness to study.
• Conducts and documents consent for participants for all types of studies, including those that are complex in nature and/or require any orders in the EHR.
• Develops consent plans and documents for participants in a variety of studies.
• Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.

Data:

• Collects and enters data.

• Develops collection or data entry SOPs or tools.
• May provide oversight or training to study team members collecting or entering data.
• Ensures accuracy and completeness of data for all studies, including those that are complex in nature.
• Recognizes data quality trends and escalates as appropriate.
• May develop tools for, and train others in, data quality assurance procedures.
• Follows required processes, policies, and systems to ensure data security and provenance.
• Recognizes and reports security of physical and electronic data vulnerabilities. Innovatively uses technology to enhance a research process.
• Assists in updating and may develop reports on study progress for the PI and other study team members and collaborators.
  
  

Study and Site Management:

• Prepares for, coordinates, and actively participates in site visits.
• Uses required EHR functionalities to manage participants and study visits.
• Communi