OHSU Dermatology is located in the Center for Health & Healing on the South Waterfront in Portland, Oregon. The Department of Dermatology is dedicated to providing our patients the best and most innovative dermatologic care for the broad range of skin, hair, nail, and mucous membrane disorders.
This position supports industry-sponsored, NIH-funded, and investigator-initiated clinical trials in the Department of Dermatology, under the supervision of Alex Ortega, MD.
Duties include: Under minimal supervision, coordinating complex therapeutic interventional clinical research protocols, and data management. Contributes to feasibility assessment and research protocol management. Assists with an audit of the billing grid against protocol-required tests and procedures to ensure accuracy and completeness. Ensures research protocol implementation. Collaborates with various OHSU departments to complete protocol-required tests and procedures, which may include the research pharmacy, Epic informatics team, clinical research billing office, and other areas.
Assists with billing review and charge reconciliation. Accurately applies investigators’ scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements. Coordinates projects with active management of expectations, timelines, and deliverables through facilitation and coordination of steps, which may include multiple clinical research protocols. Tracks and reports milestones. May assist leadership across multiple protocols to ensure appropriate and consistent project management, complex logistics, quality assurance, and participant safety. May lead data and regulatory audits of study conduct and data, emphasizing data security in concordance with federal, state, and local regulations.
Assists with trial start-up activities, including corresponding with the OHSU Institutional Review Board (IRB), eCRIS and ensuring all appropriate training and documentation is complete; recruiting, interviewing, and screening subjects for trials; following subjects throughout trial and follow-up period; ensuring all required data is collected and protocol is followed; reporting adverse reactions to trial sponsor and IRB, as appropriate; taking vital signs, performing ECGs, and drawing blood as required by the protocol; performing sample processing and shipping; performing inventory checks and maintaining trial supplies; entering data collected from subject visits into the appropriate system for clinical trials; assisting with regular reporting of study updates to IRB and
subjects, as applicable; attend meetings as directed by clinical trials investigators; additional duties may be assigned by clinical trials investigators or the Manager. May participate in onboarding and training new staff.
The duration of this appointment may be changed or eliminated if a gift, grant, or contract fund supporting this position becomes unavailable.
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