TI Senior Clinical Research Assistant

3 weeks ago

Portland, Oregon, United States Oregon Health & Science University Full time
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 or

TI Senior Clinical Research Assistant

US-OR-Portland

Job ID:
Type: Regular Full-Time
# of Openings: 1
Category: Research
Portland, OR (Marquam Hill)

Overview

Clinical Trial Coordination:

  • Screen, recruit, and consent patients for interventional and observational outpatient clinical trials related to pulmonary research. Carry out study interventions and assessments, research subject visits, and data collection, including biologic samples. Coordinate activities with clinical units, Research Pharmacy, OCTRI, etc. as needed. Perform electronic data entry and trial audits in study-specific databases and OHSU eCRIS. Organize and maintain study records. Maintain study visit supplies. Attend research meetings as needed. Assist with site initiation and monitoring visits. Assist with training other research staff in study protocols. Recognize adverse events, protocol deviations, and other study problems and report to PI or senior staff appropriately within GCP and HIPAA guidelines and institutional and sponsor requirements.

Protocol Administration:

  • Assist with feasibility analysis, development of research protocols and case report forms, eCRIS builds, and administrative requirements as necessary.

IRB, IACUC and IBC regulatory liaison.

  • Assist and monitor PI and research staff compliance with institutional and state and federal regulations. Submit protocols, amendments, and continuing review documentation for IRB review. Ensure that studies are updated, and protocols kept compliant. Provide resources to PI and staff for all aspects of protocol creation and maintenance w/ IRB, IACUC and IBC. Ensure compliance with reporting.


Responsibilities
  • Bachelor's Degree in relevant field and one year of relevant experience OR
  • associate's degree and three years of experience OR
  • four years of relevant experience OR
  • equivalent combination of training and experience. Dependent on education.
  • Strong organizational skills and attention to detail.
  • Demonstrated ability to take initiative and complete projects independently.
  • Excellent communication, both written and verbal, with fluency in English. Strong computer skills and advanced MS Office skills.
  • Experience with database management.
  • Knowledge of institutional review board (IRB) processes for submitting, modifying, terminating and continuing review of human protocols.
  • Understanding of best practices for clinical research.
  • Project management skills


Qualifications
  • Experience with conduct of interventional clinical trials
  • Working knowledge of FDA IDE/IND submission process, eCRIS, and OHSU eIRB.
  • Familiarity with electronic medical records (preferably EPIC), chart review, and medical terminology.
  • Ability to navigate research site visits with industry sponsors, in-depth knowledge of budget development and clinical trial review.
  • Bilingual (Spanish)
  • BLS certification


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