The mission of The Los Angeles Cancer Network is to provide unparalleled care to each patient that comes through our doors. We offer individualized treatment using the most recent and relevant proven advances in cancer care, curated with deliberation and compassion. LACN is committed to educating and supporting our patients and their families through every step of the way. We deliver a unique approach for every patient to ensure they receive treatment best suited to their condition, age, and other important factors. We do this by participating in important clinical research, encouraging screenings for early detection, and providing innovative treatment. We are proud to be at the forefront of cancer research through our partnership with One Oncology.

Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.

Job Description:

Regulatory Coordinator

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.

Essential Functions:

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.

Qualifications:

• Bachelor's degree required.

• Minimum of 2 years of experience in regulatory coordination within clinical research, preferably in oncology. Willing to consider those without Bachelor's degree given work experience.

• 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. Previous line management, leading a team, initiating new processes - experience preferred.

• Excellent written and verbal communication skills.

• Certification as a Clinical Research Professional (e.g., ACRP, SOCRA) not required.

Job is based at Corporate Office - Glendale, CA