This position will support the applications at OHSU Casey Reading Center, which includes database web systems and standalone software for ongoing ophthalmic clinical research studies. Responsibilities include programming, maintaining applications and codes for web databases and software, managing the ticketing system, code review, quality control, overseeing system validations and documentation, and ensuring compliance with FDA CFR 21 part 11 compliance. This position is authorized to work remotely to fulfill their responsibilities when the employee can maintain productivity.
Function/Duties of Position
- Assist in developing and maintaining homegrown C# or VB.NET web applications that supports data management and tracking for clinical trials in compliance with FDA guidelines (FDA CFR 21 part 11).
- In compliance with SCRUM-based methodology and FDA guidelines for research, implement changes to software based on requirements, document changes, and work with reading center team to test against quality requirements.
- Document all software as it relates to functional and technical requirements.
- Work in a team to document both functional and technical requirements for the research software system.
- Work in a team to thoroughly test software against requirements
- Work in a team to find ways to allow staff at several clinical trial sites to more easily upload, manage, track clinical trial data.
- Assist with clinical trial manual of procedures production and maintenance.
- Assist with management of SOPs as needed for the Casey Reading Center.
- Assist CRC staff and customers trouble-shoot issues.
- Research and develop console applications to automate reports by using Windows Server Task Scheduler.
Data Transfer Agreements and Data Exports
- Supports and perform data exports in conjunction with CRC project managers.
Master's Degree in Informatics or related field OR
Bachelor's Degree in Informatics or related field AND3 years of relevant experience
Individual must have a minimum of 1 to 3 years of relevant experience in digital system project management, experience in developing web-based architecture systems, and programming/web languages. Preference given to those who have experience in a large academic medical center (interfacing between IT and program/software programmers). Experience overseeing implementation of quality standards consistent with FDA guidelines for clinical trial systems (CFR 21 part 11).
Experience in developing and managing C#/VB.NET enterprise applications including ETL solution development.
React, D3.js, SCSS, TSQL/SQL server, HTMML5, .NET Core 3
Intermediate IIS and MS SQL server management experience.
Demonstrate strong interpersonal skills. Strong organizational skills. Ability to problem-solve. Strong written and verbal communication skills. Ability to work independently and as part of a team. Good time management skills and attention to detail. Ability to meet deadlines willingness to serve as a positive and professional role model.
Must have demonstrated record of reliable attendance, punctuality and proven successful performance in past and present.
Preferred experience in developing systems that track data and manage workflow for clinical trials.
Preferred C# or VB.NET web application development in healthcare setting.
Full stack application development experience.Maintain and update Database Markup Language (DBML) file.Intermediate knowledge of LINQ and JSON.
Evaluate legacy application functions and develop enhancements.C++ knowledge
All are welcome
Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at 503-494-5148 or email@example.com.