Hybrid Clinical Trials Regulatory Coordinator II

University of California - San Diego Medical Centers; San Diego (CA); Hybride; USD 85 000 - 137 000; Plein temps

Résumé du poste

University of California - San Diego Medical Centers is seeking a Regulatory Coordinator II for the Clinical Trials Office at Moores Cancer Center. Under supervision, you will prepare regulatory documents for UCSD IRB submissions and support trial conduct across investigators.

The role requires handling FDA, HHS, and ICH guidelines, maintaining trial documentation, and coordinating with sponsors, investigators, and staff.

Qualifications

• Six years of related experience or a Bachelor's degree plus two years of related experience.
• Experience in clinical trials research and familiarity with FDA, NIH, GCP guidelines.
• Knowledge of IRB processes and regulatory submissions.
• Experience supporting investigators and coordinating complex regulatory activities.
• Proficiency with MS Office and internet research.

Responsabilités

• Develop and maintain regulatory documents for clinical trials.
• Prepare protocols and submissions for UCSD IRB review and approval.
• Interpret and apply complex regulatory requirements across agencies.
• Coordinate with investigators, sponsors, and staff to ensure compliance.
• Provide guidance on regulatory policies and documentation.

Connaissances

Clinical trials experience

Regulatory knowledge

Communication skills

Organization & prioritization

Problem solving

Interpersonal skills

Medical terminology

Microsoft Office

Velos

eRegulatory systems

Formation

Bachelor's degree in related area

Master's degree preferred

Outils

Velos

Microsoft Office

eRegulatory systems

Description du poste

University of California - San Diego Medical Centers is seeking a Regulatory Coordinator II for the Clinical Trials Office at Moores Cancer Center. Under supervision, you will prepare regulatory documents for UCSD IRB submissions and support trial conduct across investigators.

The role requires handling FDA, HHS, and ICH guidelines, maintaining trial documentation, and coordinating with sponsors, investigators, and staff.