Clinical Trials Regulatory Compliance Lead

University of California - Los Angeles Health; Los Angeles (CA); On-site; USD 77,000 - 160,000; Full time

Job summary

The UCLA Jonsson Comprehensive Cancer Center (JCCC) seeks a regulatory affairs professional to support complex clinical research studies, ensuring compliance with UCLA, FDA, NCI, IRB, and sponsor requirements. You will manage regulatory submissions, maintain high-quality documentation, and collaborate with study monitors to enable timely study activation and ongoing oversight.

Key duties include maintaining regulatory files, addressing monitor queries, auditing DSMB monitored trials, updating

Qualifications

• 3+ years of clinical research coordination experience.
• Strong communication to interact with students, staff, faculty and sponsors.
• Ability to prioritize tasks and meet deadlines under pressure.
• Analytical skills to assess protocols and regulatory requirements.
• Excellent attention to detail for regulatory files.
• Organizational skills to maintain administrative and regulatory records.
• Proficiency with Adobe and Microsoft Office, especially Excel.
• Willingness to learn new software and processes quickly.
• Knowledge of clinical research concepts, policies, and safety regulations.
• Experience with IRBs, scientific review boards, and sponsors.

Responsibilities

• Review protocols and prepare regulatory documents for UCLA, FDA, NCI, IRB and sponsors.
• Maintain complete regulatory files and ensure timely collection of documents.
• Collaborate with study monitors to address queries and ensure compliance.
• Audit interventional trials overseen by the DSMB.
• Review monitoring/audit reports and track follow-up actions.
• Maintain and update the JCCC Clinical Trial Database for reporting.
• Interpret regulations and communicate expectations to study teams.
• Review and approve patient eligibility for DSMB-monitored studies.

Skills

Regulatory compliance

Clinical research coordination

Documentation management

Regulatory submissions

IRB knowledge

FDA / NCI familiarity

DSMB oversight

Attention to detail

Microsoft Excel

Adobe Acrobat

Education

Bachelor's degree in related area and/or equivalent

Tools

Adobe

Microsoft Excel

Job description

The UCLA Jonsson Comprehensive Cancer Center (JCCC) seeks a regulatory affairs professional to support complex clinical research studies, ensuring compliance with UCLA, FDA, NCI, IRB, and sponsor requirements. You will manage regulatory submissions, maintain high-quality documentation, and collaborate with study monitors to enable timely study activation and ongoing oversight.

Key duties include maintaining regulatory files, addressing monitor queries, auditing DSMB monitored trials, updating