Keck Medicine of USC·Los Angeles, California
The specialist will manage day-to-day clinical research operations for an NIH-funded stroke trial, including participant recruitment, data collection, and visit coordination. Additionally, they will oversee laboratory resource procurement, safety, and maintain accurate regulatory records in compliance with federal guidelines.
This is a full time staff position with an annual compensation of $75,968.95/year.
We are seeking a clinical research regulatory specialist to assist with the development and management of an NIH RF1-grant funded clinical trial in which individuals with stroke will be enrolled and participate in study activities over the course of one year.
The candidate will manage and support day-to-day clinical research operations, including participant recruitment, scheduling, data collection, study visit coordination, data entry and verification, staff training, and communications.
The candidate will also oversee laboratory resource utilization by overseeing supply procurement, inventory control, and general clinical laboratory safety.
The candidate will also maintain complete and accurate clinical research records, study files, training records and laboratory documentation, ensuring all activities comply with federal and institutional guidelines.
Minimum Education: Bachelor's degree
Additional Education Requirements Combined experience/education as substitute for minimum education Minimum Experience: 2 years Additional Experience Requirements Combined experience/education as substitute for minimum work experience Minimum Skills: Experience in clinical research compliance, regulatory research and/or operations in the academic or private sector.
Experience with submissions to the Institutional Review Board and/or the Federal Drug Administration for Investigational Drugs and Devices (IND/IDE).
Knowledgeable of Informational Conference on Harmonization-Good Clinical Practice (ICHGCP), Department of Health and Human Services (DHHS), Office of Human Research Protections (OHRP) and FDA regulations and procedures.
Ability to evaluate the risks and benefits of different solutions, and proven problem-solving and decision-making skills to uncover causes of problems.
Exemplary organization skills and attention to detail.
Proven ability to interpret, analyze, and apply pertinent policies, procedures, regulations, and requirements.
Deft interpersonal and diplomatic skills for communicating tactfully with all levels of staff and varied individuals and groups.
Demonstrated experience developing communication plans, instructional materials and related content.
Experience with office management communication software/tools (e.g., Google suite, Slack, Skype).
Bachelor's degree or Masters degree in a life science field or related, with specific experience in clinical research and lab management.
Candidates must have a Bachelor's degree and at least 2 years of experience in clinical research compliance or operations. Proficiency in IRB/FDA submissions and knowledge of ICH-GCP, DHHS, and OHRP regulations are required.
Market context
In California, Clinical Research Regulatory Specialist roles are typically driven by ongoing clinical trial activity at hospitals, research centers, and sponsors that need careful compliance support. These positions are competitive because employers look for candidates who can manage IRB and FDA submissions, apply ICH-GCP, DHHS, and OHRP rules, and bring at least 2 years of clinical research compliance or operations experience. Review the AI-summarized requirements and benefits on this platform to save time, then tailor your application to specific submission experience and regulatory knowledge.
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