TI Clinical Research Assistant 2

OHSU • Portland, OR

34d

About The Position

This position supports industry-sponsored, NIH-funded, and investigator-initiated clinical trials in the Department of Dermatology, under the supervision of Alex Ortega, MD. Duties include: assisting with trial start-up activities, including corresponding with the OHSU Institutional Review Board (IRB), eCRIS and ensuring all appropriate training and documentation is complete; recruiting, interviewing, and screening subjects for trials; following subjects throughout trial and follow-up period; ensuring all required data is collected and protocol is followed; reporting adverse reactions to trial sponsor and IRB, as appropriate; taking vital signs, performing ECGs, and drawing blood as required by the protocol; performing sample processing and shipping; performing inventory checks and maintaining trial supplies; entering data collected from subject visits into appropriate system for clinical trials; assisting with regular reporting of study updates to IRB and subjects, as applicable; attend meetings as directed by clinical trials investigators; additional duties may be assigned by clinical trials investigators or the Manager. Duration of this appointment and indicated salary may be changed or eliminated if a gift, grant, or contract fund supporting this position becomes unavailable.

Requirements

• Bachelor's in relevant field OR
• Associate's AND 2 years of relevant experience OR
• 3 years of relevant experience OR
• Equivalent combination of training and experience.
• Basic computer skills
• Strong communication skills and ability to work with people in a smaller space. Strong organizational skills and creativity. Ability to work in fast-paced environments. Competence in computer work (both PC and Macintosh) and proficiency in Microsoft Office Suite (Excel, Outlook, etc.).
• Ability to perform the job duties with or without accommodation.

Nice To Haves

• Bachelor of Arts or Bachelor of Science in Biology, Chemistry, Biochemistry or other Science.
• Previous clinical and/or research experience is highly preferred but not required.
• Basic medical experience is a plus (vital signs). Prefer experience with Epic Health Information System or internal OHSU electronic systems (eIRB, eCRIS).
• CCRP or CCRA cert, phlebotomy cert, cert nurse's aide or medical assistant a plus.

Responsibilities

• Coordinating patient visits, procedures, schedules.
• Rooming study patients, taking vital signs, drawing blood, processing lab specimens for shipment.
• Collection and entry of data from patient electronic medical records and research subject charts into study databases, internal trackers (eCRIS), and Case Report Forms and upload patient imaging.
• Resolve any data queries identified by the study monitor, auditor, or other individual reviewing the study data within tight deadlines with competing priorities. Correct any quality control issues with the data entry. Maintain data integrity including advocating for if/when data should not be changed. Additional tasks may include but are not limited to: Lab grading, obtaining and verifying study team signatures/oversight, safety report tracking and processing.
• Organizing, purging research supply area.
• Coordination of study monitor/auditor visits by scheduling and obtaining monitor/auditor access and assist the study monitor/auditor with any data entry queries. This is to occur both in preparation for the monitor/audit visit and serving as a representative to support the monitor/auditor's ability to access our site's information.
• Assisting with IRB and eCRIS submissions, study start-up and reviews
• Assisting physician, NP with study related procedures.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Hospitals
• Number of Employees: 5,001-10,000 employees