SAFETY SURVEILLANCE ASSOC II, DCRI

Work Arrangement: Remote Requisition Number: 270836 Regular or Temporary: Regular Location: Durham, NC, US, 27710 Personnel Area: MEDICAL CENTER Date: Jun 5, 2026 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. ***Position Summary*** This position will design, train, implement, and coordinate trial\- specific safety reporting and data reconciliation processes and procedures with moderate to minimal direction of Safety Surveillance Management. Participate in daily processing of safety data across multiple trials and lead the team in the prioritization of tasks of routine or moderate scope. This includes the creation and maintenance of documentation for review by sponsors and trial management and regulatory agencies. Participate in the development and implementation of standard Safety Surveillance processes; as well as precept new Safety Surveillance employees and participate in general safety reporting training programs. \*\* NOTE: This position may have an opportunity to work remotely. All Duke University and Duke Health remote workers must reside in one of the following states or districts: Arizona; California; Florida; Georgia; Hawaii; Illinois; Maryland; Massachusetts; Montana; New Jersey; New York; North Carolina; Pennsylvania; South Carolina; Tennessee; Texas; Virginia or Washington, DC., Washington (State), Connecticut, Indiana, Michigan, Maine, Ohio, New Hampshire, Alabama, Kentucky, Louisiana, Oregon, Iowa, Missouri, Delaware, and Connecticut, Rhode Island, Vermont and Wisconsin. ***Primary Responsibilities and Task*** Design and implement trial specific safety reporting processes under direction of the Medical Monitor or Safety Surveillance Management. Define reporting criteria and associated processes. Independently draft and maintain trial specific reporting plans, processes, and associated forms. Create trial\-specific safety reporting educational materials. Train trial personnel and relevant Safety Surveillance personnel on plan/processes. Participate in the design, testing