Research Coordinator II
About The Position
The Department of Psychiatry and Behavioral Sciences at the Keck School of Medicine of USC is seeking a detail-oriented and highly motivated Research Coordinator II to support clinical trials and observational research in Alzheimer's disease, related dementias, and neurodegenerative disorders. Working directly under the supervision of Dr. Lon Schneider, Professor of Psychiatry, Neurology, and Gerontology, the Research Coordinator II will oversee the day-to-day coordination of study activities, including participant recruitment, regulatory documentation, and data management. The position will support foundation-funded and industry-sponsored studies and will work closely with the Principal Investigator, Clinical Research Manager/Clinical Project Manager, study coordinators, sponsors, CROs, USC IRB, Clinical Trials Office, and other institutional partners. The successful candidate will be able to work independently on assigned responsibilities, maintain high-quality study documentation, support ongoing monitoring, and audit readiness, and contribute to improved regulatory and operational processes across the research program.
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
- Knowledge and understanding of federal, state, and institutional research regulations as well as Good Clinical Practices (GCP) and HIPPA regulations.
- Proficiency with MS Office applications
- Excellent written and oral communication skills
- Strong attention to detail
- Ability to multi-task and prioritize.
- Demonstrated ability to work independently and collaboratively.
Nice To Haves
- 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).
Responsibilities
- Coordinate study participant activities of sponsor-initiated and investigator-initiated research studies, including recruitment, screening, orientation, and correspondence.
- Plan assessments, tests, and other assigned clinical trial activities to meet research objectives and study protocol compliance.
- Monitor data collection and management procedures. Prepare data for analysis and generate and submit accurate, complete, and timely reports in accordance with established project timelines and requirements.
- Maintain regulatory documentation, including submissions, amendments, and informed consent, in compliance with FDA, GCP, IRB, HIPAA, SOPs, sponsor and institutional policies.
- Prepare sites for sponsor monitor visits and internal reviews, quality assurance checks, and audit-readiness activities.
- Provide ongoing guidance and direction 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 or requested. The University reserves the right to add or change duties at any time.
Benefits
- USC is an equal opportunity employer.
- We provide reasonable accommodations to applicants and employees with disabilities.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
