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.

Type of Research:
This position will serve as the primary nurse coordinator for clinical studies in the Division of Hematology. The coordinator will conduct clinical research studies in the areas of benign Hematology and Sickle Cell Disease, as well as serve as back up for studies as needed. The nurse coordinator will be responsible for all day to day study activities (such as subject consent and enrollment, data collection and entry, participant compensation, study monitoring activities, etc.),

and will work with the Division Lead to manage regulatory tasks (such as study start up and close out, IRB tasks, etc.). The person in this role must have organizational skills, communication skills, the ability to handle multiple assignments simultaneously, technology skills, medical terminology, and understanding of clinical medicine. They must be able to flex with the demand of work schedules and timelines.

They must demonstrate excellent attention to detail. They must be able to manage, work with, and support multiple stakeholders with different practice styles in a productive manner, and willing to learn new and complex skills as needed. The nurse coordinator must be resourceful, able to work independently, and to problem-solve on a daily basis. The preferred candidate will have Duke clinical trial experience and a desire to expand their knowledge and to share knowledge in an academic setting.

Nursing Activities:

Plan, provide, supervise, and document professional nursing care utilizing the nursing processfor patients in accordance with physician orders and established policies and procedures. Use professional nursing judgment when conducting nursing research activities to patients. Monitor and initiate corrective action to maintain the environment of care, including equipment and material resources.

Clinical Responsibilities:

* Adult Medication

* Peripheral IV Insertion and Maintenance

Operations:Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. 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. 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. May train others. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. May train others. 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.

May train or oversee others. Employ strategies to maintain retention rates. Evaluate proce sses to identify problems with retention. May train or oversee others. E mploys and may develop strategies to maintain recruitment rates and eval uate processes to identify problems. Escalates issues. May train or over see others. Screens participants for complex studies (e.g., procedural and interventional studies). May train or oversee others.

Develops or help s develop SOPs. May train or oversee others. Collects, prepares, process es,ships, and maintains the inventory of human…