Oregon Health & Science University · 7 hours ago
TI Sr Clinical Research Associate
Portland, OR
Full-time
Hybrid
Mid, Senior Level
3+ years expOregon Health & Science University is focused on advancing healthcare through research and clinical trials. They are seeking a Senior Clinical Research Associate to oversee regulatory activities for clinical studies, mentor junior staff, and ensure compliance with FDA regulations. The role involves coordinating with study teams, managing documentation, and serving as the primary liaison for patient interactions during clinical trials.
EducationHealth CareUniversities
Hiring Manager
Cire Clarke, SHRM-CP
Responsibilities
Develop and submit new IRB protocols for review
Work in collaboration with coordinator teams and leadership to ensure timely closeout of all IRB protocols covering studies that have terminated
Work in collaboration with coordinator teams and leadership to ensure all IRB protocols are up to date, including updated staffing information, accurate term dates, and that amendments and continuing reviews are submitted timely when adjustments are needed
Be the primary point of contact for IRB. Collaborate with study teams and leadership to submit changes, and address regulatory gaps with IRB protocols
Monitor and ensure documentation storage meets FDA, institutional and sponsor guidelines
Oversight and maintenance of all regulatory binders for each study
Ensure proper filing of all study correspondence between study team and sponsor for audit purposes
Ensure proper filing of all correspondence between IRB and study team for audit purposes
Ensure centralized documentation of all training certificates and medical license (if applicable) for study site staff and investigators for audit purposes
Ensure centralized documentation of all monitor visit reports. This includes site selection, site initiation, monitoring visits, and close-out reports
Will develop in collaboration with leadership standardized auditing processes that includes a consistent methodology across all trials and allows for all critical components of study conduct to be reviewed
In collaboration with leadership, identify at risk trials and perform an in-depth internal review
Provide standardized reporting of all relevant findings, including possible action items and areas for retraining or process changes
Learn FDA audit practices and work to identify and create strategies towards FDA audit in collaboration with leadership
Work with the study teams to schedule and organize any documentation or data entry needed prior to the monitoring visit
Meet and provide any needed information or data to the monitor during the visit
Assist study teams in addressing any key deficiencies identified during a site monitoring visit. Provide report out to leadership on next steps
Ensure all documentation post-visit is entered into EPIC and EDC
Responsible for direct sponsor correspondence regarding patient safety, responding to queries, reporting adverse events, conduction of visits, etc
Qualification
Required
Master's Degree in relevant field AND 3 years of clinical research coordination experience OR Bachelor's Degree in relevant field AND 5 years of clinical research Coordination experience
Strong interpersonal communication skills and excellent attention to detail
Critical thinking skills to anticipate and address potential problems
Very Strong understanding of Research Regulations and best practices
Strong knowledge of FDA regulations and audit preparation practices
Strong data abstraction and project management skills
Ability to prioritize multiple tasks at one time
Strong teaching skills with the ability to mentor junior staff
Must have excellent communication, analytical and organizational skills: both written and verbal
Ability to work independently and as part of a team while being collaborative in resolving problems
Must be proficient with computers running Windows and PC applications e.g. MS Excel, Oracle, Access, Word and PowerPoint)
Must have demonstrated excellent customer service skills both on the phone and in person
Demonstrated ability to work with a variety of diverse individuals and personalities
Must possess energy and drive to coordinate multiple projects simultaneously
Ability to use tact and diplomacy to maintain effective working relationships
Preferred
Masters degree
5+ years of experience in coordinating clinical trials
Experience in coordinating trials in cardiovascular medicine
Experience managing regulatory activities for clinical trials
Previous experience at the Research Associate or Senior Coordinator level
Prior experience leading clinical research teams and mentoring junior staff
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
2025-12-31
Medical Xpress - latest medical and health news stories
2025-12-29
2025-12-24
Company data provided by crunchbase