Employer Active
Job Alert
You will be updated with latest job alerts via emailJob Alert
You will be updated with latest job alerts via emailThe 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 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 datarelated 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 personskills have a strong statistical background including familiarity with statistical software be detailoriented and able to track multiple projects longterm. This position requires majority onsite 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 FDAregulated and nonFDAregulated 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 IDRUs 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 NTMfocused clinical trials or research protocols with a focus on dataspecific 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 startup procedures by providing necessary regulatory documents to align with OHSUs required template and language develop visit schedule in OHSUs CTMS review study feasibility and provide additional support as needed.
Masters Degree in relevant field OR
Bachelors 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 casebycase basis.
Typical work availablility defined as being available inperson or responsive to emails when working remotely: MondayFriday; between 8:00AM 4:30PM
Required Experience:
IC
Full-Time