Research Coordinator II
This position is within the Department of Psychiatry and Behavioral Sciences at the Keck School of Medicine of USC, supporting clinical trials and observational research in Alzheimer's disease, related dementias, and neurodegenerative disorders under the supervision of Dr. Lon Schneider.
About the role
The Research Coordinator II will oversee the day-to-day coordination of study activities, including participant recruitment, regulatory documentation, and data management. The role supports foundation-funded and industry-sponsored studies, working closely with the Principal Investigator, Clinical Research Manager, study coordinators, sponsors, CROs, USC IRB, Clinical Trials Office, and other institutional partners. The successful candidate will work independently, maintain high-quality study documentation, ensure audit readiness, and contribute to improved regulatory and operational processes.
Responsibilities
- Coordinate study participant activities, including recruitment, screening, orientation, and correspondence for sponsor-initiated and investigator-initiated research studies.
- Plan assessments, tests, and other clinical trial activities to meet research objectives and ensure protocol compliance.
- Monitor data collection and management procedures; prepare data for analysis and generate accurate, complete, and timely reports.
- Maintain regulatory documentation (submissions, amendments, informed consent) in compliance with FDA, GCP, IRB, HIPAA, SOPs, sponsor, and institutional policies.
- Prepare sites for sponsor monitor visits, internal reviews, quality assurance checks, and audit-readiness activities.
- Provide guidance to investigators, research personnel, and study subjects to ensure protocol compliance.
- Assist with training and orientation of research personnel on study-specific procedures, documentation standards, and regulatory workflows.
- Perform other related duties as assigned.
Requirements
- Bachelor’s degree in life sciences, health sciences, pharmacy, psychology, neuroscience, public health, regulatory science, clinical research, or a related field (or equivalent combination of education and experience).
- Minimum two years of administrative or research experience.
- Knowledge of medical environment and terminology.
- Understanding of federal, state, and institutional research regulations, Good Clinical Practices (GCP), and HIPAA regulations.
- Proficiency with MS Office applications.
- Excellent written and oral communication skills.
- Strong attention to detail and ability to multi-task and prioritize.
- Demonstrated ability to work independently and collaboratively.
Preferred Qualifications
- Master's degree or graduate training in clinical research, management of drug development, regulatory science, pharmaceutical sciences, public health, or a related field.
- Three or more years of relevant experience.
- Experience in Alzheimer's disease, dementia, neurodegenerative disease, neurology, psychiatry, geriatrics, or CNS clinical trials.
- Experience managing and coordinating research activities, including clinical trials and human subjects research.
- Experience preparing or supporting IRB submissions, informed consent documents, case report forms, study manuals, monitor visits, and audits.
- Experience developing and facilitating staff education, training, and orientation.
- Familiarity with USC systems and workflows, including OnCore, IRB submissions, REDCap, SharePoint, sponsor portals, and other Electronic Data Capture (EDC) systems and Clinical Trial Management Systems (CTMS).
Schedule
This is a full-time, on-site position located at the USC Health Sciences Campus in Los Angeles, CA. Work hours and on-site days may vary based on business needs.
Pay
The hourly rate range for this position is $35.53 - $46.59. Compensation is determined based on factors such as scope and responsibilities, candidate experience, education/training, key skills, internal peer equity, and external market considerations.