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.
Incumbent will provide oversight to the progress of clinical trials at study sites, and ensure that they are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). Duties will include but are not limited to:
- Responsible for supporting 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.
Experience in AD research is preferred.
Location: San Diego, CA
The hourly rate range for this position is $36.36 to $50.90. 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: Bachelor's degree
Additional Education Requirements Combined experience/education as substitute for minimum education
Minimum Experience: <1 year
Minimum 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.
Preferred Education: Bachelor's degree
Preferred Experience: 2 years
Preferred Skills: Experience with clinical trials. Experience with monitoring clinical trials and medical terminology. Knowledge of 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 country’s regulation pertaining to clinical trials and monitoring.
