TI Clinical Research Associate

The TI Clinical Research Associate works directly under a principal investigator and/or Research Manager/Director. Involved in the conduct of Therapeutic interventional human participants research; the development and/or management of regulatory compliance with clinical research protocols. Screens enrolls recruits and retains research participants. Coordinates study visits research schedules obtain consent blood draws sample collections monitors research activities participation etc. Collaborates with various OHSU departments to operationalize research protocols. Ensures appropriate charge designation for clinical research billing.

Therapeutic Intervention trials will be 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/testing new drugs and/or devices for the management and treatment of diabetes.

Key Responsibilities & Performance Standards

• Conducting duties for clinical studies involve recruiting and screening subjects managing study supplies prepping devices for studies scheduling and running of study visits handling of subject samples and preparing for lab analysis performing data analysis of study data and attending staff meetings.
• Collaborating on duties for device development involve assisting engineers and clinicians in device validation testing and assisting in preparation of FDA applications. This entails working extensively with diabetes technology and our custom smart phone diabetes management software applications.
• Under occasional supervision coordinates complex multi-center therapeutic interventional clinical research protocols/programs and data management. Contributes to research and assists with study protocol development. Ensures research protocol implementation meeting expectations timelines and deliverables.
• Assist with budget development billing review and charge reconciliation. Tracks and reports milestones for proper billing and payment.
• Collaborates with various internal and external entities to complete required protocol testing and procedures.
• Oversees educates and serves as an expert resource for other clinical research coordinators. Assigns and monitors tasks and their completion. Participates in training and onboarding new staff.
• Maintenance and submission of patient data and preparation for quality assurance audits and monitoring. Assist in preparation for inspections from Federal regulatory agencies. Data management on studies.
• Exercises judgment within defined Good Clinical Practice (GCP) and HIPAA guidelines to determine appropriate action via reporting mechanisms and structures in addressing adverse events as appropriate protocol deviations and other unanticipated study problems.

• Masters degree in relevant field AND 3 years of clinical research coordination experience OR
• Bachelors degree in relevant field AND 5 years of clinical research coordination 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 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.
• BLS certification Training in phlebotomy

Exposure to human fluids. Work week schedule requires flexibility in evenings and possibly overnight monitoring to meet demands of research patient visit schedules.