Clinical Research Associate

About the role

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.

Responsibilities

• Supports the Medical Safety team, specifically the Clinical Monitors, in any assigned duties such as tracking in Excel, data cleaning and site correspondence.
• Evaluates and reviews primary outcome data as outlined in the Monitoring Plan, in addition to closely monitoring safety measures. Ensures the reliability, validity & integrity of data through source document verification, remote monitor review of source documents with EDC, and generating queries as appropriate.
• Participates in the execution of clinical trials. Monitors clinical trials in accordance with GCP and industry partners’ expectations.
• Interacts closely with Clinical Monitors and Quality Assurance to review Monitor Visit Reports per GCP guidelines, internal SOPs and Monitoring Plans prior to uploading reports to the eTMF.
• Initiates NTF's as applicable per review of Monitor Visit Reports and uploads Clinical Monitoring documents to the eTMF.
• Reviews and evaluates clinical test results and interviews and ensures that interviews and tests are rated, scored and standardized. Reviews and reports on the quality and integrity of clinical data.

Requirements

Experience in AD research is preferred.

Qualifications

• Minimum Education: Bachelor's degree
• Preferred Education: Bachelor's degree
• Minimum Experience:
• Preferred Experience: 2 years

Skills

• Familiarity with monitoring of clinical trials and medical terminology.
• Familiarity with the drug development process.
• Knowledge of ICH guidelines and Good Clinical Practices (GCP).
• Understanding of FDA regulations pertaining to Good Clinical Practices.
• Knowledge of local and/or national regulations pertaining to clinical trials and monitoring.

Benefits

N/A

Pay

The hourly rate range for this position is $36.36 to $50.90.

Schedule

N/A