TI Clinical Research Assistant II

The OHSUPSU 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 OHSUPSU School of Public Health specializes in evaluations of infectious disease in individual patients and the population as a whole. The groups 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 studyrelated 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 studyspecific processes and/or tools.
• Interface with study team other researchers and external partners to ensure study milestones are met.
• Build visit schedules in OHSUs CTMS for upcoming research protocols.
• Develop regularly documents including editing Sponsor documents to match OHSU requirements as part of study startup.

The individual in this role will have excellent personskills be detailoriented and able to track multiple projects longterm. This position requires majority onsite work with potential opportunity to work remotely. There may be other opportunities within the group including manuscript review and independent research.

• 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 startup procedures though development of necessary regulatory documents to align with OHSUs required template and language develop visit schedule in OHSUs 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.

• Bachelors Degree in relevant field OR

• Associates 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.

• Masters Degree in Public Health or currently working toward Masters Degree in Public Health 12 years of experience in clinical research including at least 1 year of clinical trial coordination
• REDCap database
• Familiarity with OHSUs CTMS (eCRIS)
• Good Clinical Practice (GCP) Certification SOCRA or ACRP Certification
• Phlebotomy training

Due to the unpredictability of research activities hours may have to be shifted to accommodate research participants study visits and data collection. Some days may require starting earlier or later in the day as well as working past 5PM. Intermittent evening or weekend work and/or availability may be required.

Work location will include the Vanport Building clinics within Physicians Pavilion CHH 1 and the OCTRI out/inpatient spaces in the Hatfield Building. Remote work is an option and may be approved on a casebycase basis.

Typical work availablility defined as being available inperson or responsive to emails when working remotely: MondayFriday; between 8:00AM 4:30PM