California Licensed Regulatory Compliance Officer

Job Summary

A company is looking for a Regulatory Compliance Officer.

Key Responsibilities:

• Review clinical research protocols and manage regulatory submissions to ensure compliance with relevant authorities
• Maintain accurate regulatory files and collaborate with study monitors to ensure compliance with laws and policies
• Audit interventional clinical trials and track follow-up actions from external monitoring/audit reports

Required Qualifications:

• Experience in regulatory compliance for clinical research studies
• Knowledge of federal, state, and institutional regulations related to clinical trials
• Ability to interpret regulations and communicate compliance expectations effectively
• Experience with maintaining clinical trial databases and documentation
• Familiarity with auditing processes and monitoring of clinical trials