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.

Operations:

• Knowledgeable in regulatory and institutional policies and processes; applies them appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes.

• Under supervision, assists with managing investigational products including arrival, storage, and handling (requisitions, inventory, and reordering).

• Prepares for study monitoring and audit visits under supervision.

• May document some participant-level information for non-complex studies (e.g., questionnaires, data registry, scripted) outside of the EHR.

• Follows SOPs and strategies to manage and retain research subjects.

• Recruits research participants according to study protocol.

• Screens participants for complex studies (e.g., procedural and interventional studies). May train or oversee others.

• Employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens under supervision.

• Assists with establishing and maintaining study-level documentation.

• Schedules participants for research visits (excluding those requiring EHR access).

• Prepares necessary documents, equipment, supplies, etc., in compliance with the protocol.

• Conducts and documents non-complex visits and scripted testing or interviews.

• May manage participant payment.

• Contributes to the effective facilitation of team meetings to achieve predetermined objectives. May lead multidisciplinary meetings with various stakeholders.

Ethics:

• Identifies all AEs and determines whether or not they are reportable. Collaborates with the PI to determine AE attributes, including relatedness to the study. May train or oversee others.

• Conducts and documents consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care. May train or oversee others.

• Develops consent plans and documents for participants in various studies. May train or oversee others.

• Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others.

Data:

• Enters and collects data. Develops data entry or collection 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 complex ones.

• Recognizes data quality trends and escalates as appropriate. May develop tools for, and train others in, data quality assurance procedures.

• Recognizes and reports security vulnerabilities of physical and electronic data. May develop or review data lifecycle and management plans for multiple study protocols.

• Knowledgeable about requirements for depositing data and following repository and metadata specifications for data sharing. With guidance, locates and follows repository-specific requirements to sub