Clinical Research Program Administrator

Overview 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. The incumbent will support the medical monitoring team in providing oversight of 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 all applicable regulatory requirements. Responsibilities Support medical monitoring during study conduct, assist with site questions on inclusion/exclusion criteria or other protocol issues, and evaluate adverse events (AEs) and serious adverse events (SAEs), laboratory and other safety parameters, medical history, and concomitant medications. Assess and evaluate protocol deviations and recommend actions to be taken. Communicate with reporting site investigators and site staff regarding medical and safety issues. Collaborate with medical monitors and site clinical monitors to support the medical safety team. Contribute to the development of Safety Management Plans, Medical Monitoring Plans, Clinical Monitoring Plans, Pharmacovigilance Plans, and Risk Management Plans. Assist in performing MedDRA and WHODrug coding. Attend and/or present at investigator, internal, and external project team meetings. Assist in overseeing the Medical Safety Specialist team within the Medical Safety unit. Interact with industry and academic partners. Assist in scientific manuscript writing and editing. Preferred Education & Experience Medical degree or equivalent in a medical-related field or life science. 3+ years of experience or graduate degree (master's or doctoral). Understanding of Alzheimer’s disease and/or the drug development process. Experience in interacting with cross-functional study team members. Knowledge, Skills, and Abilities Thorough knowledge of clinical research concepts, practices, and FDA regulations. Knowledge of ICH Guidelines regarding development phases, clinical research, and medical writing standards. Demonstrated ability to interpret and apply these guidelines to document writing. Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills and attention to detail. Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones and appropriately elevate complex issues. Excellent interpersonal, active listening, and influencing skills; establish and maintain professional and productive relationships with team members. Use a balanced approach to problem solving, applying flexibility and persistence as appropriate. Read, write, and speak fluent English with excellent verbal and written communication skills. Location: San Diego, CA The annual base salary range for this position is $99,102.14 - $141,885.98. When extending an offer of employment, the University of Southern California considers factors such as 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, and 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 screening implications for the position for which you are applying. Job ID: REQ20175618 Posted Date: 05/22/2026 #J-18808-Ljbffr University of Southern California