Regulatory Coordinator

Location: Glendale, CA

Pay: $35 - $50/hour

Position Summary:

The Regulatory Coordinator is responsible for the coordination, preparation, and maintenance of regulatory documentation and compliance for clinical trials. This role ensures adherence to local, state, and federal regulations, including but not limited to FDA, ICH, and GCP guidelines, and supports the smooth conduct of clinical research studies at the site. The coordinator supports clinical research teams by facilitating study start-up approvals and maintaining documentation of regulatory compliance throughout the study duration for research involving human subjects. This role also serves as a central regulatory resource for clinical research staff and reports to the

Director of Research Services.

Essential Functions:

Regulatory Document Management

• Prepare, review, and submit regulatory documents for IRB submissions, amendments, continuing reviews, and protocol deviations.
• Review informed consent forms for institutional language; coordinate with legal teams and sponsors to align language with Clinical Trial Agreements (CTAs).
• Maintain complete and up-to-date regulatory binders, including signed investigator agreements, CVs, and medical licenses.
• Develop and manage electronic regulatory files per institutional and sponsor standards.
• Track protocol approvals, renewals, and amendments to ensure regulatory compliance.

Compliance and Reporting

• Monitor study compliance with federal regulations (FDA, OHRP) and international guidelines (ICH, GCP).
• Maintain site readiness for audits and inspections; prepare and organize regulatory files and documentation.
• Support audit response efforts and assist in implementing corrective actions.
• Report adverse events (AEs), serious adverse events (SAEs), and protocol deviations promptly and accurately. Provide updates to the Director of Research Services.

Communication and Coordination

• Serve as the primary point of contact with regulatory agencies, sponsors, and IRBs for submissions and status updates.
• Collaborate with Principal Investigators, study coordinators, and research staff to ensure timely documentation.
• Facilitate communication with sponsors, CROs, and regulatory bodies.
• Participate in study start-up meetings, site initiation visits, and monitoring visits as required.

Training and Compliance Support

• Train research staff on evolving regulatory requirements.
• Develop and distribute regulatory training materials.
• Ensure informed consent documents are current and accurately reflect protocol amendments.

Study Start-Up and Maintenance

• Coordinate with study teams to obtain essential regulatory documents before study initiation.
• Monitor and document enrollment progress and compliance with study protocols.
• Assist with close-out procedures, including archiving and final report submission.

Qualifications:

• Bachelor’s degree required (or equivalent experience).
• Minimum of 2 years of experience in regulatory coordination within clinical research, preferably in oncology.
• Knowledge of FDA regulations, ICH guidelines, and GCP standards.
• Experience with IRB submissions, central IRBs, and regulatory document management.
• Proficiency in Microsoft Office Suite and electronic regulatory systems.
• Strong organizational skills and attention to detail with the ability to manage multiple priorities.
• Preferred: experience in team leadership, initiating new processes, or previous line management responsibilities.
• Excellent verbal and written communication skills.
• Certification as a Clinical Research Professional (e.g., ACRP, SOCRA) is not required but is a plus.