TI Clinical Research Assistant II

Department Overview

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 II position in will provide support for several NTM and bronchiectasis clinical trials protocols, as well as other infectious disease observational or epidemiological studies. This position will also provide project management for several clinical trials, which could include supporting database development, 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.

 

Responsibilities include:

• Independently verify potential participants through chart review & discussion with 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.
• Support database build and management, data querying, and analyses.
• 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.
• Build visit schedules in OHSU’s CTMS for upcoming research protocols.
• Develop regularly documents, 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, and able to track multiple projects long-term. This position requires majority on-site work, with potential opportunity to work remotely. There may be other opportunities within the group including manuscript review and independent research.

Function/Duties of Position

• Assist the management of research study daily operations, monitoring protocol compliance and patient toxicities, adverse event reporting and regulatory submissions (IRB, FDA). May act as a project manager for specific protocols. Independently interact with study sponsors and provide all necessary documentation in a timely manner. Mentor junior staff on research protocols and provide support.
• Assist senior staff with database build and management, monitoring and issuing queries, performing analyses as needed, running reports, and presenting information to relevant stakeholders.
• Support new clinical trial start-up procedures though development of necessary regulatory documents to align with OHSU’s required template and language, develop visit schedule in OHSU’s CTMS, and provide additional support as needed.
• Complete special projects under the guidance of one of the group epidemiologists, including manuscript review, database support, etc.

Required Qualifications

• 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.

Preferred Qualifications

• 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
• REDCap database
• Familiarity with OHSU’s CTMS (eCRIS)
• Good C