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.

 

 

This position is for a Clinical Research Nurse Coordinator within the Duke Neonatal-Perinatal Research team and will support projects involving families and neonates. The position will work with multiple investigators and other members of the team on clinical research studies. Biological samples will be collected and processed from neonates/parents per protocol. The responsibilities and duties will require this position to primarily work in person with some opportunities for hybrid local remote work. Previous work with federal multi-site grants or neonatal nursing experience is preferred but not required. 

 

Type of Research:
Position will manage multiple neonatal clinical research studies including those that are complex in nature. The position will work within a team environment and communicate/interact with unit clinician and nursing staff

Operations:
Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. Prepares FDA regulatory submissions in collaboration with ORAQ, including development, submission, and maintenance of relevant documentation. Addresses FDA review and/or potential hold issues in collaboration with the Principal Investigator (PI). Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes. Maintains study level documentation for international studies. May develop resources and tools for management of international studies, and/or coordinate with other entities or offices. Is responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants. Serves as the primary liaison with sponsors, IDS, and other parties as necessary. Follows protocol schema for randomization and blinding/unblinding. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. Maintains participant 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. Employ 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 participants for complex studies (e.g., procedural and interventional studies). Develops or helps develop SOPs. May train or oversee others. Collects, prepares, processes, ships, and maintains the inventory of human research specimens, primarily those requiring complex procedures. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). 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 AEs, and determines whether or not they are reportable.  Collaborates with the 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 Maestro Care. Develops consent plans and documents for participants in a variety of studies. Develops and submits documentation and information for IRB review. Communicates with the IRB staff and reviewers and handles issues appropriately. Prepares and submits documents needed for regulatory and safety reporting to sponsors