Regulatory Coordinator

The Los Angeles Cancer Network•Glendale, CA

22h•Onsite

About The Position

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. They will support clinical research teams by facilitating the study start-up approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects. S/he will be responsible maintaining accurate and up-to-date regulatory files. S/he will serve as a central regulatory resource for staff conducting clinical research. This position reports to the Director of Research Services.

Requirements

Bachelor’s degree required. Willing to consider those without Bachelor’s degree given work 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, protocol amendments, and regulatory document management.
Experience working with multiple central IRBs, understanding their submission process and requirements.
Proficiency with electronic systems and Microsoft Office Suite.
Strong organizational skills, attention to detail, and ability to manage multiple tasks efficiently.
Excellent written and verbal communication skills.

Nice To Haves

Previous line management, leading a team, initiating new processes – experience preferred.
Certification as a Clinical Research Professional (e.g., ACRP, SOCRA) not required.

Responsibilities

Regulatory Document Management: Prepare, review, and submit regulatory documents for initial IRB submission, amendments, continuing reviews, and protocol deviations. Reviews informed consents for institutional language and work with legal and sponsors to ensure CTA language is consistent with consent.
Maintain accurate and up-to-date regulatory binders, including signed investigator agreements, CVs, and medical licenses.
Develop and maintain electronic regulatory files in compliance with institutional and sponsor requirements.
Track protocol approvals, renewals, and amendments to ensure study compliance.
Compliance and Reporting: Monitor study compliance with federal regulations (FDA, OHRP) and guidelines (ICH, GCP).
Maintain site readiness for internal and external audits and inspections, including preparing regulatory files and ensuring proper documentation.
Assist in preparing responses to audit findings and implementing corrective actions.
Ensure prompt and accurate reporting of adverse events (AEs), serious adverse events (SAEs), and protocol deviations. Provides study updates, deviations, and SAE reports to Director of Research Services.
Communication and Coordination: Serve as the primary point of contact for regulatory agencies, sponsors, and IRBs regarding submission and status updates.
Collaborate with the Principal Investigator (PI), study coordinators, and research staff to ensure accurate and timely documentation.
Facilitate communication between the research site and sponsors, CROs, and regulatory bodies.
Participate in study start-up meetings, site initiation visits, and monitoring visits as needed.
Training and Compliance Support: Educate and train research staff on regulatory requirements and updates.
Develop training materials to enhance regulatory compliance at the site.
Ensure that informed consent documents are up-to-date and reflect protocol amendments.
Study Start-Up and Maintenance: Coordinate with study teams to obtain essential documents prior to study initiation.
Track and document study enrollment progress and protocol compliance.
Assist with study close-out activities, including regulatory document archiving and final reports.