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 a Project Administrator to serve as a Quality Assurance (QA) representative and will be responsible for supporting inspection readiness of the ATRI, particularly in the areas of Trial Master File (TMF) and internal and external audits. Incumbent will contribute to the creation and implementation of strategies to maintain the integrity of the quality system.
Key responsibilities include but are not limited to:
- Support study specific deliverables and milestones of TMF(s)
- Perform TMF quality reviews and provide status reports
- Support study teams in the resolution of TMF-related queries or quality issues
- Assist in the development and execution of audit/inspection procedures, including TMF
- Protect the integrity of the quality system by promoting the consistent application of standards and best practices
- Evaluate documents, records and procedures, including audit materials, to ensure they comply with regulations, policies, procedures and customer requirements
- Recommend improvement initiatives based on identified areas of improvement
Essential skills and abilities:
- Analytical skills / assessment / evaluation
- Attention to detail
- Planning, organization, and time management
- Problem identification, reporting, resolution
- Communication – written and oral
- Gathering data / evidence
- Research information / regulations / requirements
- Knowledge of applicable principles
- Interpretation of policies and trends
- Interviewing / questioning – asking the right questions – listening
- Conceptualization
- Tact, diplomacy
- Ability to handle multiple ongoing projects or tasks
- Stays informed of developments in field by reading pertinent literature, attending meetings, and participating in professional associations as appropriate.
- Working knowledge of clinical trials, medical terminology as it pertains to clinical trials, and/or research concepts, ICH guidelines and Good Clinical Practices (GCP).
- Ability to collaborate with all members to gather, interpret and consolidate data, generate documentation and reporting, review data and information for presentation and review.
Preferred education:
Master’s degree or combined experience/education as substitute for education.
Preferred experience:
3 or more years of experience preferred
Preferred Field of Expertise:
Experience with Trial Master File (preferably DIA Reference Model) and monitoring or auditing. Ability to work collaboratively in a team setting. Familiarity with Microsoft Office and Microsoft Excel. Ability to analyze data and familiarity with data analytics procedures and software. Ability to analyze and conduct problem solving. Ability to train and motivate others and ability to work effectively with diverse populations. Excellent written and oral communication skills. Pharmaceutical or Device Research experience.
The annual base salary range for this position is $77,215.84 – $107,844.71. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate’s work experience, education/training, key skills, internal peer equity, federal, state and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.
USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying.
Location: San Diego, California
Minimum Education: Master’s degree, Combined experience/education as substitute for minimum education
Minimum Experience: 3 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.
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