TI Clinical Research Assistant 2

Oregon Health & Science UniversityOregon Health & Science University

Portland, OR, US
Job Description

Department Overview

This position is under the supervision of Wayne Clark, MD and the Program Coordinator.  The Oregon Stroke Center Clinical Research Assistant serves as the Regulatory Coordinator for all research studies conducted by the program. This position assists in clinic and other various study specific activities.

Function/Duties of Position

Regulatory Coordinator Responsibilities:

  • Study start-up documentation collection
    • Create, collect and complete regulatory documents for all research studies
    • Collect signatures from relevant personnel on various regulatory documents
    • Communicate with pharmaceutical companies, OHSU research team, and other OHSU departments involved with the conduct of research studies
    • Coordinate and document necessary study training with OHSU research team and other OHSU departments involved with the conduct of research studies
    • Provide complete and accurate regulatory documents to pharmaceutical companies prior to study initiation
  • Document Management
    • Keep all ongoing documents for all studies up to date and ready for monitoring visits, including both hard-copies and electronic copies
    • Keep track of and organize documents such as IRB approval Memos, IRB Approved ICFs, Sponsor Communications, DSMB Reports, Safety Reports, etc.
    • Maintain all staff documents such as CVs, license, GCPs, and assessment certifications
    • Maintain lab and pharmacy documents
    • Keep regulatory binders organized and in good working condition
  • IRB Submissions
    • Responsible for submitting IRB submissions in a timely manner to prevent lapse in coverage and ability to enroll into all studies
    • Submissions include modifications, continuing review, reportable new information, protocol deviations and study close-outs.

General Research Assistant Responsibilities:

  • Schedule research patients for follow-up
  • Walk patients to lab or imaging
  • Rooming and vitals
  • Processing labs
  • Performing EKGs

Clinic Responsibilities:

  • Assist with checking-in and rooming patients
  • Covering phones
  • Helping patients with virtual visit setup
  • Placing Zio Patch heart monitors

Required Qualifications

  • Bachelor’s 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
  • Customer service experience
  • Strong interpersonal skills
  • Commitment to working in a team environment
  • Excellent written and verbal skills
  • Highly organized and able to work independently
  • Strong attention to detail
  • Problem solving
  • Able to perform the essential functions of the position with or without accommodation
  • Ability to be flexible and adaptable to changes in the day-to-day workflow
  • Working knowledge of Microsoft Office
  • Ability to sit for long periods of time

Preferred Qualifications

  • Data management experience
  • Patient experience
  • Previous work in research
  • Working knowledge of Macintosh computers
  • Familiarity with clinical research, medical terminology, and clinical contact with patients

Additional Details

Please include a cover letter.

All are welcome

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. As an organization devoted to the health and well-being of people in Oregon and beyond, OHSU requires its employees to be fully vaccinated against COVID-19.
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