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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:
Research
Trial Management:
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
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
Other
Colleges & Universities
$79k-106k (estimate)
10/12/2022
07/26/2023
ohsu.edu
PORTLAND, OR
15,000 - 50,000
1887
Private
DUC HOTAN
$3B - $5B
Colleges & Universities
Oregon Health & Science University is a nationally prominent research university that operates dental, medical, nursing and pharmacy schools.
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