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TI Clinical Research Assistant II
US-OR-Portland
Job ID: 2025-34067 Type: Regular Part-Time # of Openings: 1 Category: Research Portland, OR (Downtown)
Overview
Assist the management of research study daily operations, monitoring protocol compliance and patient toxicities, adverse event reporting and regulatory submissions (IRB, FDA). May act as a project manager for specific protocols. Independently interact with study sponsors and provide all necessary documentation in a timely manner. Mentor junior staff on research protocols and provide support.Assist senior staff with database build and management, monitoring and issuing queries, performing analyses as needed, running reports, and presenting information to relevant stakeholders.Support new clinical trial start-up procedures though development of necessary regulatory documents to align with OHSU's required template and language, develop visit schedule in OHSU's CTMS, and provide additional support as needed.Complete special projects under the guidance of one of the group epidemiologists, including manuscript review, database support, etc. Responsibilities
Bachelor's Degree in relevant field OR Associate's AND 2 years of relevant experience OR 3 years of relevant experience OR Equivalent combination of training and experience Strong written, verbal comminication and proficeincy in MS Office Suite; meticulous record keeping and organization skills. Working knowledge of IRB guidelines and FDA, DHHS, other agency guidelines that govern clinical research. Experience with EndNote or other citation software.
Qualifications
Masters Degree in Public Health or currently working toward Masters Degree in Public Health 1-2 years of experience in clinical research including at least 1 year of clinical trial coordinationREDCap databaseFamiliarity with OHSU's CTMS (eCRIS)Good Clinical Practice (GCP) Certification, SOCRA or ACRP CertificationPhlebotomy training Equal employment opportunity, including veterans and individuals with disabilities.
