Hybrid Clinical Trials Regulatory Coordinator II

UC San Diego; San Diego (CA); Hybrid; USD 85,000 - 137,000; Full time

Job summary

UC San Diego's Moores Cancer Center is seeking a Regulatory Coordinator II for the Clinical Trials Office. The role develops and maintains regulatory documents for trials, ensuring IRB approvals and regulatory compliance across FDA, HHS, and UCSD IRB processes.

The position requires experience in clinical research environments, knowledge of NIH and GCP, and strong organizational and communication skills to coordinate with investigators and sponsors.

Qualifications

• Six years of related experience, education/training, OR a Bachelor's degree in related area plus two years of related experience/training.
• Demonstrated experience in clinical trials research with knowledge of experimental protocols, data gathering, protocol design and evaluation.
• Strong knowledge of investigational protocols (data management, query resolution, protocol design and protocol implementation).
• Knowledge of NIH, GCP, IATA Shipping, and Bloodborne Pathogens.
• Experience coordinating with supervisors to maintain efficient research teams.
• Experience in clinical research environments (CRO, academic research, or research hospital).
• Experience working with FDA policies regulating clinical trials.
• Proficiency in Word, Excel, Velos, and internet browsing.
• Ability to find creative and innovative solutions to center needs.
• Ability to discern independent work from supervision.
• Working knowledge of medical/scientific terminology.
• Strong problem-solving and conflict resolution skills.
• Excellent organizational, written, and verbal communication skills.

Responsibilities

• Prepare and maintain regulatory documents for IRB submissions.
• Interpret and apply complex clinical research regulations (FDA, HHS, UCSD IRB, CTO).
• Coordinate with investigators and staff across multiple contacts.
• Assist supervisor in maintaining an efficient clinical research team.
• Perform regulatory duties within clinical trial environments.

Skills

Clinical trials research

Regulatory interpretation

Strong communication

Problem solving

Organizational skills

Independent judgment

Team coordination

Education

Bachelor's degree in related area

Master's degree in a social or basic science

Tools

Microsoft Office

Velos

Internet research

Job description

UC San Diego's Moores Cancer Center is seeking a Regulatory Coordinator II for the Clinical Trials Office. The role develops and maintains regulatory documents for trials, ensuring IRB approvals and regulatory compliance across FDA, HHS, and UCSD IRB processes.

The position requires experience in clinical research environments, knowledge of NIH and GCP, and strong organizational and communication skills to coordinate with investigators and sponsors.