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. Be You. Position Overview: The Duke Vaccine and Trials Unit DVTU conducts, primarily, vaccine research across all age groups. The DVTU mission is to evaluate strategies aimed at the prevention, treatment, and control of human infectious diseases, assess the safety and effectiveness of new and existing vaccines, and further our understanding of measures of protection from infection. Minimum Requirements: Completion of an Associate’s degree. Work requires a minimum of two years of relevant research experience. Completion of DOCR North Caroline state approved Clinical Research Apprenticeship program may substitute for one year of required experience. A Bachelor’s degree may substitute for 2 years required experience. Preferred Qualifications: N/A Be Bold. Position Description: Operations:Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. Maytrain 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 naturee.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 processes to identify problems with retention. May train or oversee others. Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues. May train or oversee other
