The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California is an academic institute comprised of an expert panel of scientific collaborators committed to advancing the development of new treatments for Alzheimer’s Disease (AD) through innovative clinical trials.
ATRI is looking for an experienced Quality Assurance Manager to ensure data quality by reviewing workflow, audit material and procedures with the goal of assuring data of known quality and accuracy. Responsibilities include but are not limited to:
- Maintain Quality System documentation, i.e., organized and up-dated.
- Protect the integrity and safety of Quality Records and Quality System.
- Review of data to ensure its compliance with ATRI’s processes as well as the customer’s requirements.
- Writes and edits basic to moderately complex analytical reports for potential submission to regulatory authorities and clients.
- Perform internal audit activities as directed by ATRI leadership.
- Review and up-date SOPs per the review schedule as directed by ATRI leadership
- Archive data according to SOPs.
- Responsible for managing the Quality Assurance team including interviews, performance appraisals, timekeeping, etc.
- Good working knowledge of clinical trials, medical terminology as it pertains to clinical trials, and/or research concepts.
- Ability to collaborate with all members to gather, interpret and consolidate data, generate documentation and reporting, review data and information for presentation and review.
- Working knowledge of ICH guidelines and Good Clinical Practices (GCP).
Location: San Diego, CA
Salary is dependent on education and experience.
Minimum Education: Master’s degree, Combined experience/education as substitute for minimum education
Minimum Experience: 5 years, Combined education/experience as substitute for minimum experience
Minimum Field of Expertise: Directly related education and project administration experience in specialized field represented by project
REQ20055809 Posted Date: 02/02/2018 - Thru date - 3/31/2018
Location/Region: Los Angeles, CA (US)