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 position will participate in the IDRU Data Team, which is a small team within the group, working on projects including the design, documentation, testing, and implementation of research studies. The IDRU Data Team supports data-related aspects of projects within the group including the conduct of data/statistical procedures, as well as other collaborators in SPH and across OHSU.
Responsibilities of this clinical research data analyst position include:
The individual in this role will have strong person-skills, have a strong statistical background including familiarity with statistical software, be detail-oriented, and able to track multiple projects long-term. This position requires majority on-site work, with potential opportunity to work remotely. This position will be involved in manuscript review and represent the team at conferences.
Supporting data management of both FDA-regulated and non-FDA-regulated clinical trial protocols and research projects, both within IDRU and across OHSU collaborators. These tasks include helping with the development of statistical analysis plans, database build and management, running data validations and querying data, interface with study Sponsors, help to manage IRB submissions and approvals, provide reports for IND submissions to the FDA, and data analyses and interpretation.
Participate in the IDRU’s Data Team work, including supporting study design, conducting data analyses, utilizing appropriate statistical methods, providing education, training, and to colleagues within the team, and communicate with stakeholders as needed.
Help manage study coordination work for several NTM-focused clinical trials, or research protocols, with a focus on data-specific tasks. Responsibilities may include unblinded staff tasks, such as monitoring data, preparing DMC reports, meeting with DMSB and communicating results with sites, interfacing with study Sponsor, and managing regulatory documentation.
Support new clinical trial start-up procedures by providing necessary regulatory documents to align with OHSU’s required template and language, develop visit schedule in OHSU’s CTMS, review study feasibility, and provide additional support as needed.
Master’s Degree in relevant field OR
Bachelor’s Degree in relevant field AND 2 years of relevant 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.
STATA, SAS, R, SPSS, or other statistical software.
Due to the unpredictability of research activities, hours may have to be shifted to accommodate grant, conference, or manuscript submission deadlines. Some days may require starting earlier or later in the day, as well as working past 4:30PM or 5PM. Intermittent evening or weekend work and/or availability may be required.
Work location will include the Vanport Building, and may include 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 case-by-case basis.
Typical work availablility, defined as being available in-person or responsive to emails when working remotely: Monday-Friday; between 8:00AM – 4:30PM
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