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Perform a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research, under the direction of a Clinical Research Coordinator (CRC) or similar Clinical Research Unit (CRU)/Oversight Organization (OO) designee. Participate in day-to-day operations related to the collection, compilation, and documentation of clinical research data. This position will work in shifts, 1st, 2nd, and 3rd as well as working on weekends. Work Performed 1. Research Operations and Data Entry (80%) - Under supervision, may document some participant-level information for non-complex (e.g., questionnaire, data registry, scripted) studies outside of the electronic health record (EHR), collect information from sources including the EHR to assist study team in determining eligibility, and employ simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Prepares documents, equipment, supplies, etc., and assists with the conduct and documentation of non-complex visits and scripted testing or interviews. Assist with maintenance of study level documentation. Follows standard operating procedures (SOPs) and strategies to manage and retain research subjects. Participates in study team meetings. Enters basic data for research studies. Scores tests and measures that do not require interpretation, according to the protocol. Under supervision, corrects and documents incomplete, inaccurate, or missing data for non-complex studies. Follows SOPs for quality assurance. Follows required processes, policies, and systems to ensure data security and provenance. Learned and uses new technology when required. 2. Safety and Ethics (5%)- Under supervision may collect information about adverse events (AEs), identified in the protocol or investigator brochure. 3. Leadership and Professionalism: (5%): Maintains Duke and project-specific training requirements. Communicate with other study personnel as required for study implementation and routine problem resolution. |