TI Sr. Clinical Research Assistant

Function/Duties of Position

This position is under the supervision of the Division Manager and Division Head of the Oregon Stroke Center. The Regulatory Coordinator is responsible for ensuring all research studies conducted by the Oregon Stroke Center are compliant and follow all IRB and FDA guidelines.

 

Regulatory Coordinator Responsibilities:

• Study start-up
  • Draft the initial ICF according to OHSU’s standards and working with the Sponsor to reach a final draft for IRB submission.
  • Preparing the initial study submission for IRB and coordinate between the Sponsor and OHSU’s IRB to make adjustments to study documents and address any concerns brought up by the IRB.
  • Collect all initial regulatory documentation to be ready for site activation by the time IRB approval is received.
  • Provide complete and accurate regulatory documents to pharmaceutical companies prior to study initiation.
• 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.
• Regulatory Compliance
  • Coordinate the maintenance of all study specific regulatory documents for all studies, including both hard-copies and electronic copies.
  • Collaborate with designated study research coordinator in preparing, assisting during, and addressing any follow up items from sponsor monitoring visits.
  • 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. This includes saving and filing documents such as IRB approval Memos, IRB Approved ICFs, Sponsor Communications, DSMB Reports, Safety Reports, etc.
  • Assist designated Research Coordinator to complete a final review prior to study close-out.
• 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.
• Onboarding new employees
• Send instructions to new employees for various trainings and request documents necessary to add new employees to studies.
• Train Research Coordinators on regulatory basics.

• Create and maintain a standardized process for all regulatory aspects including a method to properly report RNI’s.
• Collaborate with other Oregon Stroke Center staff to build and maintain a standard for the Division to be in compliance with IRB and FDA regulations.

 

Other Research Responsibilities:

• Contact potential study participants to introduce to studies, schedule, coordinator and complete visits as needed.
• Process specimens to send out to central lab.

Clinic Responsibilities:

 

• Assist with checking-in and rooming patients.
• Place Zio Patch heart monitors.

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Required Qualifications

• 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
• 1 year of IRB experience
• Previous work in clinical research
• 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 and problem solving skills
• 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

• Working knowledge of Macintosh computers
• Familiarity with clinical research, medical terminology, and clinical contact with patients

Additional Details

On-the-job training for outpatient clinic duties; this includes training on how to take patient vitals.

All are welcome

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