Hybrid Clinical Trials Regulatory Coordinator II

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

Job summary

UC San Diego Health is seeking a Clinical Trials Regulatory Coordinator II to support regulatory documentation across oncologic clinical trials. The role ensures accurate protocol development, submissions to UCSD IRB, and ongoing regulatory compliance.

Supervisory interaction and cross-functional collaboration are essential as work occurs at Moores Cancer Center with occasional remote tasks. The position requires extensive experience with clinical research, NIH/GCP familiarity, and ability to

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 and knowledge of experimental protocols, data gathering, protocol design and evaluation.
• Strong knowledge of investigational protocols (data management, query resolution, protocol design and implementation).
• Knowledge of NIH, GCP, IIPP, OIA, IATA Shipping of Blood Specimens, and Bloodborne Pathogens.
• Experience in coordinating with investigators and staff to maintain efficient clinical research activities.
• Experience with FDA policies regulating clinical trials.
• Proficiency with word processing, spreadsheets, and internet browsers; ability to perform literature searches.
• Ability to find creative solutions and to establish useful resources and University contacts.
• Ability to work independently and determine actions with supervisor input as needed.
• Working knowledge of medical and scientific terminology.
• Strong problem-solving and conflict resolution skills.
• Excellent organization, prioritization, and attention to detail under changing priorities.
• Strong interpersonal, written, and verbal communication skills and diplomacy.

Responsibilities

• Develop and maintain regulatory documents for clinical trials conducted by investigators at the Cancer Center.
• Prepare clinical trial protocols and related regulatory submissions for UCSD IRB approval.
• Advise investigators and staff on interpretation and execution of complex clinical research regulations, policies and procedures.

Skills

Clinical trials experience

GCP knowledge

FDA regulations

Microsoft Office

Education

Bachelor's degree in related area

Master's degree in a related field

Tools

Velos

Microsoft Office

Job description

UC San Diego Health is seeking a Clinical Trials Regulatory Coordinator II to support regulatory documentation across oncologic clinical trials. The role ensures accurate protocol development, submissions to UCSD IRB, and ongoing regulatory compliance.

Supervisory interaction and cross-functional collaboration are essential as work occurs at Moores Cancer Center with occasional remote tasks. The position requires extensive experience with clinical research, NIH/GCP familiarity, and ability to