TI Sr Clinical Research Assistant
On-sitePortland, Oregon, United States
Job Summary
Coordinate complex therapeutic interventional trials in the Epilepsy Division with minimal supervision, independently preparing and submitting regulatory packages to the IRB. Manage recruitment and retention of research volunteers by screening eligible participants, explaining study design in lay language, and creating recruitment materials. Conduct study visits involving vital signs collection, ECGs, lumbar punctures, and skin biopsies, while collecting, processing, and shipping laboratory samples. Maintain regulatory compliance and Good Clinical Practice guidelines, including initial IRB submissions, modifications, annual reviews, and adverse event reports. Enter data into electronic capture systems, resolve sponsor queries, and track study billing and invoices. Requires a Bachelor's or Associate's degree with relevant experience, clinical skills such as phlebotomy, and familiarity with Epic. On-campus location with occasional remote work; ability to stand and walk for long periods during visits.
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
- Clinical research coordination, including conduct of multiple complex clinical trials and regulatory document maintenance, in role(s) with minimal oversight
- Experience using electronic medical records system(s)
- Independent IRB submissions (initial submissions, modifications, &/or annual review)
- Clinical skills, such as phlebotomy, specimen processing, ECG, & vital signs measurements
- Knowledge of clinical research regulatory standards and guidelines
- Extremely well-organized with high attention to detail
- Able to efficiently manage multiple tasks and demands with competing deadlines
- A self-starter, able to work independently while being effective and efficient
- Enjoys collaborating with and supporting colleagues in a team environment
- Excellent written and verbal communication skills
- Working with human biological samples is required
- In-person attendance at and participation in community events (approx. 6 per year), many of which occur on the weekend
- Ability to stand and walk throughout the OHSU campus for long periods of time during study visits
Desired Qualifications
- Experience using the Epic medical record system
- Familiarity with the procedures of the OHSU Institutional Review Board
- Training: CITI (Collaborative Institutional Training Initiative) courses – Good Clinical Practice, Human Subjects Research, & Responsible Conduct of Research
- Certification: SOCRA CCRP (Society of Clinical Research Associates Certified Clinical Research Professional)
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