Research Data Analyst 2 (Quality Assurance Associate)

Department Overview

The Casey Reading Center (CRC) is a comprehensive ophthalmic reading center with a customizable experience, offering a secured image transmission platform and sophisticated functional and imaging analysis to ensure the highest quality and insight derived from clinical trials. This position will support the quality assurance system (QMS) at the Casey Reading Center (CRC) related to their ongoing clinical research studies. The Quality Assurance Associate position will support the quality improvement efforts at the reading center. The person will create and maintain quality documents, staff certifications, and data checks/integrity documents at the Casey Reading Center (CRC). Responsibilities involve overseeing standards operating policies (SOPs) and quality management systems (QMS). The tasks performed for the CRC must comply with Good Clinical Practices and FDA 21 CFR Part 11. The position will ensure regulatory compliance to HIPAA, ISO, Good Clinical Practices (GCP), FDA 21 CFR Part 11, and applicable regulations. The position is remote or telework.

Function/Duties of Position

Core Job Responsibilities: Assist the Reading Center Operations Director in Reading Center activities as follows:

• Quality Assurance Management
• Audit preparation and Support
• Regulatory compliance

Quality Assurance Management:

• • Enhance the training program to provide ongoing training to CRC personnel. Oversee staff certification
  • Address emergent trial issues with quality assurance issue documentation or corrective and preventative action (CAPA) plans 

Document Management:

• • Create and maintain SOPs as needed for the Casey Reading Center
  • Assist with periodic review, versioning, and implementation of new SOPs; ensure staff are appropriately trained on SOPs
  • Create or revise quality documents

Audit Preparation and Support:

• • Schedule and/or conduct internal audits
  • Create Sponsor audit plans and inspection readiness checklists

Compliance:

• • Guide the team related to the regulatory requirement including but not limited to ISO, quality management, GCP, and HIPAA

Required Qualifications

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 Qualifications

Preferred experience in Quality Management/ Assurance. Experience in quality assurance, regulatory affairs, consulting, and project management functions.

 

 

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 aaeo@ohsu.edu.