Regulatory Specialist - Pacer Group : Job Details

Position: Regulatory Specialist

Location: Los Angeles, CA 90025

Schedule: Full-time, Day Shift (5x8 Hours | 8:00 AM – 5:00 PM)

Contract Duration: 13 Months

About the Role

• Seeking a Regulatory Specialist to support clinical research activities by ensuring compliance with regulatory requirements, institutional policies, and ethical guidelines. This role is 100% onsite and requires strong regulatory expertise, organizational skills, and experience working within clinical research.

Key Responsibilities

• Prepare and submit continuations and amendments in compliance with regulatory and institutional requirements.
• Complete forms, generate reports, and maintain documentation to support clinical trial protocols.
• Audit and maintain regulatory files to ensure compliance with Good Clinical Practice (GCP) and HIPAA.
• Monitor the status of regulatory submissions and amendments end-to-end.
• Partner with investigators and research staff to maintain accurate and up-to-date regulatory documentation.
• Provide status updates in cross-functional meetings and support internal/external audits.
• Identify opportunities for quality and workflow improvements in regulatory processes.
• Uphold strict patient confidentiality and adhere to all applicable regulatory and ethical standards.

Required Qualifications

• Bachelor's degree.
• Minimum 3 years of relevant clinical research experience.
• Strong regulatory experience with ability to strictly adhere to compliance and ethical requirements.
• Proficiency with electronic data capture (EDC) systems such as Medidata, VeevaVault, and MedRio.

Preferred Qualifications

• Experience with oncology or chemotherapy-related research.
• Certified Clinical Research Professional (CCRP) certification strongly preferred.

Vaccination Policy

• COVID-19: Not required
• Flu Vaccine: TBD (facility guideline not specified)