Clinical Data Associate

Location: San Diego, CA

Hybrid Schedule (3 days per week on-site)

The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California is an academic institute comprised of an expert group of scientific collaborators committed to advancing the development of new treatments for Alzheimer's Disease (AD) through innovative clinical trials.

Key Responsibilities:

• Data Quality Assessment: Identifying, assessing, and resolving data quality problems across various sources.
• Data Cleaning: Perform data review data cleaning and root cause analysis, query generation in the data management systems and follow-up until queries are properly closed to ensure it meets quality standards and objectives. Performs external & internal labs and Imaging data reconciliations.
• Data Quality Standards Development: Developing and implementing data quality standards, policies, and procedures. Contributes to the development of study documentation development such as the User Acceptance Plan, Data Entry Manual, Data Management Plan, Post Entry Check specification and other study documents. Contribute to continuous process improvement and process optimization initiatives.
• Data Monitoring and Reporting: Monitoring data quality metrics, reporting on data quality issues, and tracking remediation efforts. Identifies eCRFs and lab query trends and propose solutions to minimize the issues.
• Collaboration: Liaison with the clinical team such as the CRAs, Project Manager, Analytical Developers, Lead Data Managers, clinical sites and Vendors
• Contribute to the database launch, maintenance, and database lock under the direction of the Lead Data Manager.
• Collaborates with the lead Data Manager to perform User Acceptance Testing (UAT) on the Data Management System as per the Edit Check Specifications.
• Performs eTMF review and loading of study documentations in the eTMFs.

Salary is dependent on experience and education.

REQUIREMENTS:

• STEM related bachelor's degree
• 1.5 years of experience in clinical trials at a pharmaceutical, biotechnology, or academic clinical research institute or on hands Clinical Data Management experience is preferred.
• Experience with Electronic Data Capture (EDC) systems
• Proficiency in MS Office, including Word, Excel, and PowerPoint, required
• Excellent Analytical and Problem-solving skills: The ability to analyze complex data, identify patterns, attention to detail and develop solutions to data quality issues in a timely manner.
• Communication and Collaboration: Excellent written and verbal communication skills to effectively communicate and present data quality issues and solutions.
• Preferred - Trained in GCP.
• Knowledge of database-related tools (e.g., SQLite, MySQL) is preferred
• Experience with AI tools (ChatGPT, Copilot, etc.) preferred
• R, R Studio, Python programming experience preferred

The hourly rate range for this position is $26.77 - $34.13. 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.

Minimum Education: Associate's degree, Combined experience/education as substitute for minimum education
Minimum Experience: 6 months
Minimum Field of Expertise: Requires good attention to detail with prior data entry experience. Some knowledge of medical terminology.