The TI Senior Clinical Research Assistant is a highly organized and motivated clinical research coordinator who works directly with principal investigators with 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 the treatment of diabetes. As part of the Diabetes Research team, the TI Senior Clinical Research Assistant will oversee the research coordinators and will work closely with study participants, perform study procedures per the research study protocols and regulatory requirements, including participant recruitment, data and specimen collection, study procedures, data entry and organization of study records and adverse event reporting. The TI Senior Clinical Research Assistant will work with clinical, research, financial, and pharmacy units at OHSU as well as with external organizations such as sponsors, clinical research organizations, and regulatory bodies. Additionally, the TI Senior Clinical Research Assistant will supervise and train research assistants, student workers and volunteers. As the TI Senior Clinical Research Assistant is expected to work with minimal supervision, strong interpersonal and critical thinking skills for independent problem solving are needed to achieve scientific and administrative objectives.

Device Development support:

• Will assist the engineers and clinicians (PIs) in diabetes device validation testing.  This position will also assist the principal investigator with preparations for FDA applications

Clinical Trial Coordination:

• Screen, recruit, and consent participants for interventional and observational outpatient clinical trials related to diabetes 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 on 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.

Research assistant, student worker and volunteer supervision:

• This position will supervise: research assistants, student workers and volunteers, including recruitment, onboarding, training and coaching and complying with division and institutional standards for managing research staff. Supports the supervision and audit work done by research staff.

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 ClinicalTrials.gov reporting.

Protocol Administration:

• Will work directly with Principal Investigator  to develop feasibility analysis, development of research protocols and case report forms, OnCore/eCRIS builds, and administrative requirements as necessary.

Other Responsibilities: Other duties as assigned.

 

• 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
• 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

• 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.

• (SOCRA)CCRP, ACRP,

  BLS certification, 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 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.