Oregon Health & Science University · 6 days ago
TI Senior Clinical Research Assistant
Portland, OR
Full-time
Onsite
Mid, Senior Level
$50K/yr - $75K/yr
4+ years expOregon Health & Science University is seeking a TI Senior Clinical Research Assistant to work directly with principal investigators on outpatient clinical trials related to diabetes. The role involves overseeing research coordinators, performing study procedures, and ensuring compliance with regulatory requirements while working closely with study participants and various clinical units.
EducationHealth CareUniversities
Responsibilities
Will assist the engineers and clinicians (PIs) in diabetes device validation testing. This position will also assist the principal investigator with preparations for FDA applications
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
This position will supervise: research assistants, student workers and volunteers, including recruitment, onboarding, training and coaching and complying with division and institutional standards for managing research staff. Supports the supervision and audit work done by research staff
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
Will work directly with Principal Investigator to develop feasibility analysis, development of research protocols and case report forms, OnCore/eCRIS builds, and administrative requirements as necessary
Other duties as assigned
Qualification
Required
Bachelor's Degree in relevant field AND
1 year of relevant experience OR
Associate's AND
3 years of relevant experience OR
4 years of relevant experience OR
Equivalent combination of training and experience
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
Preferred
Experience with conduct of interventional clinical trials
Working 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
Company
Oregon Health & Science University
OHSU is a health and research university provides patient care, research, education of the next generation of health care.
10001+ employees
H1B Sponsorship
Oregon Health & Science University has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (136)
2024 (132)
2023 (121)
2022 (132)
2021 (109)
2020 (103)
Funding
Current Stage
Late StageTotal Funding
$36.6MKey Investors
U.S. Small Business AdministrationNational Institute of Allergy and Infectious DiseasesHyundai Hope On Wheels
2024-09-25Grant
2022-11-21Grant· $4.7M
2022-09-27Grant· $0.3M
Leadership Team
Tarek Salaway
Chief Executive Officer, OHSU Health
Lawrence Furnstahl
Executive Vice President & Chief Financial Officer
Recent News
News-Medical.Net
2026-01-16
2026-01-16
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