TI Clinical Research Assistant 2

Oregon Health & Science University • Portland, OR

1d • Hybrid

About The Position

The OHSU-PSU School of Public Health (SPH) is aligned with the American Public Health Association in declaring racism a public health crisis, and our School is committed to becoming an antiracist SPH. We are working to center social justice in our internal and external work as a school and are committed to addressing structural and institutional racism, and to holding ourselves accountable to this work. The Infectious Disease Research Unit is based out of the OHSU-PSU School of Public Health specializes in evaluations of infectious disease, in individual patients and the population as a whole. The group’s experts are national leaders in two rare diseases that predominantly affect the lungs – nontuberculous mycobacterial, or NTM disease, and bronchiectasis. In addition to NTM disease and bronchiectasis, other areas of research include rheumatologic disease, drug safety and pharmacoepidemiology, and vaccines. This TI clinical research assistant position will provide study coordination support for several clinical trials and infectious disease epidemiological studies focused on the natural history of NTM, HIV, yellow fever, and other infectious diseases. This position may also provide project management for several clinical trials, which could include supporting database development and testing, data management, and monitoring data, interfacing with subsites, and managing regulatory documentation. As part of this role, this individual will interface across multiple departments and divisions as part of supporting PIs across OHSU. Candidates with experience working with individuals diagnosed with NTM or bronchiectasis, FDA-regulated clinical trials, Patient Reported Outcomes (PROs), or experience with biorepositories are preferred. Responsibilities include: Review potential participants through chart review & discuss eligibility with the clinical trial manager and/or investigators. Schedule and perform all participant visits, including informed consent, blood draws, and other study-related tasks as needed. Responsible for scheduling/communicating assessments and appointments with participants. Maintain regularly documentation and prepare status reports. Maintain study data and address queries in a timely manner. Collaborate with study team to identify and develop new study-specific processes and/or tools. Interface with study team, other researchers, and external partners to ensure study milestones are met. Place orders in Epic and track billable procedures. Support regulatory document development, including editing Sponsor documents to match OHSU requirements, as part of study start-up. The individual in this role will have excellent person-skills, be detail-oriented, able to work on multiple projects, and be comfortable taking direction and reaching out when there are issues.

Requirements

• Bachelor's Degree 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
• Strong written, verbal comminication and proficeincy in MS Office Suite; meticulous record keeping and organization skills.
• Working knowledge of IRB guidelines and FDA, DHHS, other agency guidelines that govern clinical research.
• Experience with EndNote or other citation software.
• Ability to perform the job duties with or without accommodation.

Nice To Haves

• Bachelor's degree in Public Health or Masters Degree in Public Health or currently working toward Masters Degree in Public Health
• 1-2 years of experience in clinical research including at least 1 year of clinical trial coordination
• A working knowledge of FDA, DHHS, IRB and other agency guidelines that govern clinical research.
• Experience working with Epic, or other EMR systems.
• REDCap database
• Familiarity with OHSU’s CTMS (OnCore)
• Good Clinical Practice (GCP) Certification, SOCRA or ACRP Certification
• Phlebotomy training

Responsibilities

• Perform on-site visits with research subjects, including obtain informed consent, perform research procedures including vital signs and specimen collection, document visits, and enter data.
• Maintain documentation for research protocol, including.
• Support data abstraction and entry for both the NW NTM Biobank, the Bronchiectasis Research Registry, and other ID-related protocols. Abstraction will be done mainly via Epic EMR, but other databases could be utilized.
• Complete special projects under the guidance of one of the group epidemiologists, including manuscript review, database support, administrative support for clinical trials, etc.

What This Job Offers

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