Department Overview

The Division of Endocrinology, Diabetes and Clinical Nutrition and the Harold Schnitzer Diabetes Health Center provides expert care for patients with diabetes and endocrine disorders in outpatient and inpatient settings. In addition to our commitment to outstanding clinical care, we are proud of our extensive research programs, our educational missions, and our fellowship training program.

The Senior Clinical Research Assistant is a highly organized and motivated clinical research coordinator who assists 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 coordinator 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 coordinator 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 coordinator may supervise and train research assistants, student workers and volunteers. As the coordinator 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.

Function/Duties of Position

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.

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

Research assistant, student worker and volunteer supervision: Supervise research assistants, student workers and volunteers, including recruitment, onboarding, training and coaching and complying with division and institutional standards for managing research staff. Supervise and audit work done by research staff.

Study Costs and Invoicing: Assist with tracking study related expenditures and preparing fiscal documentation for supervisor review/approval.

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.

Other duties as assigned.

Required Qualifications

* 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

Preferred 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.

* (SOCRA)CCRP, ACRP, BLS certification, trained in phlebotomy

All are welcome

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.