- Screens, recruits and retains subjects in clinical and translational research studies
- Carries out study interventions and assessments, research subject visits, and data collection, including biologic samples.
- Coordinates study activities with clinical units, Research Pharmacy, OCTRI, CEDAR, etc. as needed.
- Performs electronic data entry and trial audits in study-specific databases and OHSU eCRIS.
- Organizes and maintains study records.
- Prepares and submits protocols, amendments, and continuing review documentation for IRB review.
- Ensures compliance with all protocol and regulatory requirements and helps prepare required submissions and reports.
- Assists with site initiation and monitoring visits and FDA audits as needed.
- Reports adverse events, protocol deviations and other study problems to the PI or senior staff appropriately within GCP and HIPAA guidelines and institutional and sponsor requirements.
- Maintains a high level of professionalism and exhibits exceptional teamwork in dealing with customer contacts, including regular in-person meetings, telephone, and email communication
- Bachelor's in relevant field 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.
- 1 year of relevant experience.
- Familiarity with electronic medical records (preferably EPIC), chart review and medical terminology.
- Experience with REDCap
- Knowledge of institutional review board (IRB) processes for submitting, modifying, terminating and continuing review of human protocols.
- Understanding of best practices for clinical research, including research ethics.
- Ability to navigate research study visits.
- SoCRA or equivalent.
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Research Assistant 2 - Portland, United States - OHSU
Description
Department OverviewThe Research Assistant 2 is an organized and motivated clinical researcher who will assist Dr. Scott Naugler on research studies related to liver disease. The Research Assistant 2 may also assist other investigators with clinical trials related to gastroenterology and hepatology. The position is supervised by the Research Program Manager.
The Research Assistant 2 will perform study procedures per the research study protocols and regulatory requirements, including participant recruitment, data and specimen collection, study visits, data entry, organization of study records, and adverse event reporting.
The Research Assistant 2 may facilitate the submission and renewal of research protocols to the OHSU Institutional Review Board (IRB).
The individual in this role will have excellent intrapersonal and critical thinking skills, be detail-oriented, and able to multi-task.
The Division of Gastroenterology and Hepatology provides expert diagnosis and treatment of patients with gastrointestinal and liver diseases in ambulatory clinics, endoscopy suites, and inpatient settings.
Research and protocol administration:
Client Service:
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