Job Description:
Oregon Health & Science University

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.


Senior Clinical Research Assistant -OR- Clinical Research Associate

US-OR-Portland

Job ID: 2024-29470
Type: Regular Full-Time
# of Openings: 1
Category: Research
Portland, OR (Marquam Hill)

Overview

The Pediatric Nephrology Division in the Department of Pediatrics at OHSU is recruiting for a Senior Clinical Research Assistant OR Clinical Research Associate position to assist with patient-oriented clinical research.

The researcher will assist in the planning, implementation, operation, and evaluation of all clinical aspects of clinical research projects. The Senior Research Assistant will be independently responsible for assigned research studies and will interact with internal departments and external sponsor representatives as applicable. The researcher is responsible for recruiting, screening, and consenting patients for clinical trials in either ambulatory or inpatient settings. The position will require clinical study coordination, including facilitating subject entry into research projects, follow-up visits, biological specimen handling, and case report form completion. The researcher will be responsible for data collection, monitoring of source documents, report generation, meeting with sponsor’s monitors, continuous quality assessment, application of protocol guidelines. The individual will work attend any training for the study and participate in all meetings by phone or zoom with sponsor related to the study. In addition, the individual will work collaboratively with other study coordinators, nursing, pharmacy, specialty service centers, and physician staff in the care, scheduling, and management of research subjects.

The Senior Research Assistant is independently responsible for regulatory compliance and IRB submissions related to assigned studies. The Senior Research Assistant will assist with preparing study budgets and work with the contracting team from study start-up to study clousre. The Senior Research Assistant will assist in the supervision and professional development of Research Assistants, interns, volunteers, and students.

The Research Associate will assist with scholarly activites, such as data analysis, grant, abstract, and manuscript development, and research results dissemination and will also work closely with Pediatric Nephrology investigators to develop a fiscal plan for the research unit for the future. Also the Research Associate will be responsible for writing up policies and procedures for the research unit that are compatible with OHSU policies.

Responsibilities

For a Senior Clinical Research Assistant:

• A 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.

For a Clinical Research Associate:

• Master's Degree in relevant field AND 3 years of clinical research coordination experience OR Bachelor's Degree in relevant field AND 5 years of clinical research Coordination experience
• SoCRA or ACRP may be require

Job related knowledge, skills and abilities:

• Knowledge of FDA, DHHS and other agency guidelines and regulations that govern clinical.
• Competency in Microsoft word, Excel and powerpoint.
• Strong organizational skills and attention to detail.
• Demonstrated ability to take initiative and complete projects independently.

*** The candidate will need to complete the research coordinator workshop provided by OHSU within the first 6 months of employment

Qualifications

• Master of Public Health or similar degrees
• Experience coordinating industry, federal, and investigator-initiated clinical trials.
• Working knowledge of electronic database management systems, eCRIS, eIRB, and REDCap.
• Experience with electronic medical records (EPIC preferred) chart review, and medical terminology.
• Knowledge of statistical software (R, SPSS, STATA).
• Project management skills.
• Knowledge of IRB process for submitting, modifying, and continuing review of research protocols.
• Certification from an appropriate accredited certifying body (e.g. ACRP or SOCRA).
• CITI training for HSP, GCP, and RCR.

PI239659128

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