Job Description

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.

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.

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.

USC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law or USC policy. USC observes affirmative action obligations consistent with state and federal law. 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.

We provide reasonable accommodations to applicants and employees with disabilities. Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone at [click to reveal phone number](213) 821-8100 , or by email at [click to reveal email address] [email protected] . Inquiries will be treated as confidential to the extent permitted by law.

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