This position will support work done at the Casey Reading Center (CRC) related to their ongoing clinical trials and studies. This will be a remote or hybrid position. Responsibilities will involve performing quality management and regulatory compliance as well as performance and document management.  Many of the tasks performed for the CRC must comply with International Conference on Harmonization, Good Clinical Practices, FDA 21 CFR Part 11, and The EU General Data Protection Regulation (GDPR).

Core Job Responsibilities- Assist the Casey Reading Center Associate Director in Reading Center activities as follows:

• Quality management
• Quality Assurance
• Regulatory Compliance (21 CFR Part 11)
• Data Integrity

Research

• Develop and implement quality management system
• Establish document and risk management system
• Create internal audit; vendor audit plans; project and program specific manuals
• Develop data check programs to verify accuracy of the data before exporting data to the Sponsors
• Create inspection readiness SOPs
• Enhance training program to provide ongoing training to QC and Reading personnel.
• Perform validation on new tools that are result of research and implemented for the Casey Reading Center
• Understand the CRC test types and the data export from each.
• Create and maintain SOPs as needed for the Casey Reading Center.
• Assist with annual review of SOPs and implementation of new SOPs
• Develop and implement process improvements for current workflows
• Lead or work in a group to roll out new software including testing and validation
• Identify issues for the Casey Reading Center site and create tickets.
• Meet with software developers to discuss new software roll out
• Use Matlab, python code and other software languages to create software for use by CRC (e.g., batch file conversions and high level programming to create tools for structure / function analysis)
• Tracking unresolved issues and following up with sponsor to explain how the loss of data may affect the trial analysis
• Assist with issuing and maintaining procedure departures, procedure deviations, protocol deviations, and protocol departures related to reading center related trial protocols and procedures.
• Lead and address the CAPA documents as needed for the projects

Trial Management:

• Answering trial workflow questions
• Emergent trial issues

Customer support

Using knowledge of software troubleshooting techniques and understanding of trial protocols/procedures requirements and how inquiries relate to regulatory authority requirements (e.g., FDA 21 CFR Part 11)

Compliance

• Draft and issue memos and notes to file to sites as needed.
• Issuing and maintain procedure departures, procedure deviations, protocol deviations, and protocol departures related to reading center related trial protocols and procedures.
• Run reports on our database and review performance management with the Associate Director

Master's Degree in relevant field AND 2 years of relevant experience OR Bachelor's Degree in relevant field AND 4 years of relevant experience

 

Expert-level experience with Microsoft Word and Excel.  Working knowledge of medical terminology.  Strong relationship building skills.  Exceptional customer service skills - both in person and on the phone.  Exceptional interpersonal skills, strong organizational skills, ability to problem solve.  Demonstrated evidence of strong written and verbal communication skills.  Ability to manage competing priorities.  Ability to meet deadlines and urgent system needs.  Ability to work independently; 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 clinical trials.

 

Experience in quality assurance, regulatory affairs, consulting, and project management functions

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 aaeo@ohsu.edu.


As an organization devoted to the health and well-being of people in Oregon and beyond, OHSU requires its employees to be fully vaccinated against COVID-19.