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TI Senior Clinical Research Assistant
US-OR-Portland
Job ID: 2025-33397 Type: Regular Full-Time # of Openings: 1 Category: Research Portland, OR (Marquam Hill)
Overview
Clinical Trial Coordination: Screen, recruit, and consent participants for interventional and observational outpatient clinical trials related to diabetes research. Carry out study interventions and assessments, research subject visits, and data collection, including biologic samples. Coordinate activities with clinical units, Research Pharmacy, OCTRI, etc. as needed. Perform electronic data entry and trial audits in study-specific databases and OHSU eCRIS. Organize and maintain study records. Maintain study visit supplies. Attend research meetings as needed. Assist with site initiation and monitoring visits. Assist with training other research staff on study protocols. Recognize adverse events, protocol deviations, and other study problems and report to PI or senior staff appropriately within GCP and HIPAA guidelines and institutional and sponsor requirements. Protocol Administration: Assist with feasibility analysis, development of research protocols and case report forms, OnCore builds, and administrative requirements as necessary. Research assistant, student worker and volunteer supervision: Supervise research assistants, student workers and volunteers, including recruitment, onboarding, training and coaching and complying with division and institutional standards for managing research staff. Supervise and audit work done by research staff. Study Costs and Invoicing: Assist with tracking study related expenditures and preparing fiscal documentation for supervisor review/approval. IRB, IACUC and IBC regulatory liaison: Assist and monitor PI and research staff compliance with institutional and state and federal regulations. Submit protocols, amendments, and continuing review documentation for IRB review. Ensure that studies are updated, and protocols kept compliant. Provide resources to PI and staff for all aspects of protocol creation and maintenance w/ IRB, IACUC and IBC. Ensure compliance with ClinicalTrials.gov reporting.Other duties as assigned. Responsibilities
Bachelor's Degree in relevant field and one year of relevant experience OR Associate's degree and three years of experience OR four years of relevant experience OR equivalent combination of training and experience Dependent on education Strong organizational skills and attention to detail Demonstrated ability to take initiative and complete projects independently Excellent communication, both written and verbal, with fluency in English Strong computer skills and advanced MS Office skills Experience with database management Knowledge of institutional review board (IRB) processes for submitting, modifying, terminating and continuing review of human protocols Understanding of best practices for clinical research Project management skills
Qualifications
Experience with conduct of interventional clinical trialsWorking knowledge of FDA IDE/IND submission process, eCRIS, and OHSU eIRB Familiarity with electronic medical records (preferably EPIC), chart review, and medical terminology Ability to navigate research site visits with industry sponsors, in-depth knowledge of budget development and clinical trial review (SOCRA)CCRP, ACRP, BLS certification, trained in phlebotomy Equal employment opportunity, including veterans and individuals with disabilities.
