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)