TI Senior Clinical Research Assistant

TI Senior Clinical Research Assistant

Location: US-OR-Portland

Requisition :  |
Position Category: Research |
Job Type: Research |
Position Type: Regular Full-Time |
Posting Salary Range: $50,128.00 - $75,171.20 per year |
Posting FTE: 1.00 |
Posting

Schedule:

Monday - Friday with flexibility |
Posting

Hours:

7:00am - 4:00pm with flexibility |
HR Mission: School of Medicine |
Drug Testable: Yes

The TI Senior Clinical Research Assistant is a highly organized and motivated clinical research coordinator who works directly with principal investigators on outpatient clinical trials related to type 1 and type 2 diabetes. Protocols involve understanding the causes and nature of diabetes in the human body, the characteristics of diabetes, and developing new drugs for its treatment. As part of the Diabetes Research team, the assistant oversees research coordinators and works closely with study participants, performing study procedures per the research study protocols and regulatory requirements, including participant recruitment, data and specimen collection, data entry, organization of study records and adverse event reporting.

The role collaborates with clinical, research, financial, and pharmacy units at OHSU, as well as external organizations such as sponsors, CROs, and regulatory bodies. Additionally, it supervises and trains research assistants, student workers, and volunteers. The position requires independent work with minimal supervision, strong interpersonal and critical thinking skills for problem solving, and the ability to meet scientific and administrative objectives.

• Device Development support: Assist engineers and clinicians in diabetes device validation testing and help prepare FDA applications.
• Clinical Trial Coordination: Screen, recruit, and consent participants for interventional and observational outpatient trials related to diabetes research; carry out study interventions, assessments, and data collection, including biologic samples; coordinate activities with clinical units, Research Pharmacy, OCTRI, etc.; perform electronic data entry and trial audits; maintain study records; oversee study visit supplies; attend research meetings; assist with site initiation and monitoring visits;
  
  train other staff on protocols; recognize and report adverse events, protocol deviations, and other study issues to the PI or senior staff within GCP, HIPAA, and institutional/sponsor requirements.
• Research assistant, student worker and volunteer supervision: Supervise research assistants, student workers and volunteers, handling recruitment, onboarding, training, coaching, and compliance with division and institutional standards; support supervision and audit activities.
• IRB, IACUC and IBC regulatory liaison: Assist and monitor PI and staff compliance with regulations; submit protocols, amendments, and continuing review documents; ensure studies remain compliant; provide resources for protocol creation and maintenance; maintain Clinical Trials.gov reporting.
• Protocol Administration: Work directly with the PI to develop feasibility analyses, research protocols, case report forms, OnCore/eCRIS builds, and handle administrative requirements.
• Other Responsibilities: Perform other duties as assigned.

• Bachelor's Degree in a relevant field, or Associate's Degree with equivalent combination of training and experience.
• Relevant experience ranging from 1 year (for Bachelor) to 4 years, depending on degree level, or an equivalent combination of training and experience.
• Strong organizational skills and attention to detail.
• Demonstrated ability to take initiative and complete projects independently.
• Excellent written and verbal communication skills in English; strong computer skills and advanced MS Office proficiency.
• 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.

• Experience conducting 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 and in-depth knowledge of budget development and clinical trial review.
• Certifications:
  
  (SOCRA) CCRP, ACRP, BLS; trained in phlebotomy.

Exposure to human fluids. Work week schedule requires flexibility and overnight on-call shifts to meet demands of research patient visit schedules.

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…