Under general supervision, assists in coordinating the details of therapeutic interventional research studies and protocol documentations, patient scheduling, and data collection. Assists in complex studies. Works under the direction of a Principal Investigator, Research Manager/Program Administrator, Division Manager and Senior team members. Will provide assistance to coordinate and conduct multiple research protocols in a team setting. Will involve working closely with multiple OHSU clinical and research areas, including the research pharmacy, the Epic team, and the clinical research billing office. Will interface and work with industry sponsors to ensure proper and compliant study conduct. Works closely with research and clinical investigators and team members across multiple sites to ensure the safety of research participants. Is able to set priorities and timelines for complex research activities.
Exercises judgment within defined Good Clinical Practice and HIPAA guidelines to determine appropriate action via reporting mechanisms and structures (Institutional Review Board) in recognizing adverse events, protocol deviations, and other unanticipated study problems and reports to senior staff appropriately. May assist with project logistics and all parts of research program coordination or management, in coordination with other OHSU clinical and research departments. May collate, enter, and present research data for analysis. May assist with administrative and regulatory duties related to the study as assigned.
Must have excellent communication, organization, and customer service skills, and must be a self-starter with ability to work well in a team environment. Responsible for patient assessment for protocol eligibility, counseling of patients regarding study schemas; study calendar and treatment plan; thorough written tracking of patient visits' for billing purposes, patient education; coordinating follow-up care and liaison between patients and other members of the healthcare research team. Will be responsible for the coordination of multiple research studies for the Rheumatology Research team including maintenance and submission of patient data; evaluation of protocol activities; maintenance and preparation of quality assurance audits, and management of investigational drugs. Ensures timely completion of work for all assigned trials.
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