TI Sr Clinical Research Associate - Military veterans preferred

Oregon Health & Science University

Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at 503-494-5148 or aaeo@ohsu.edu.


TI Sr Clinical Research Associate

US-OR-Portland

Job ID: 2025-32980
Type: Regular Full-Time
# of Openings: 1
Category: Research
Portland, OR (Waterfront)

Overview

The Senior Coordinator oversees all regulatory activities for each study in the program.  This includes the following:

IRB Protocol Management and Development

• In collaboration leadership and based on sponsor protocol, 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.

Study Documentation

• 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
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Audit Support/Preparation

• 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.

Monitoring Visits

• 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.

• 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

• 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

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