Senior Regulatory Coordinator

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🕒 May 13

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City of Hope

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

🔬 Science

🤝 Non-profit

💰 $5.4M Grant - City of Hope on 2024-05

Biotechnology • Science • Non-profit

City of Hope is a nonprofit, NCI-designated comprehensive cancer center and research hospital near Los Angeles that provides patient care, conducts translational biomedical research, and offers education and clinical trials across a national network. It focuses on cancer, diabetes, and other life‑threatening diseases, combining clinical services, laboratory science, training and community outreach to develop new treatments and support patients and families.

📋 Description

• Leads regulatory oversight for clinical trials, including preparation and submission of amendments, continuing reviews, safety reports, deviations, and study close-out documentation to IRB, DSMC, PRMC, IBC, and other regulatory committees while ensuring compliance with institutional and federal guidelines. • Maintains accurate and audit-ready electronic regulatory binders and essential study documents, ensuring ongoing compliance with GCP, protocol requirements, regulatory standards, and internal policies during monitoring visits and external audits. • Serves as a primary regulatory liaison between investigators, research teams, sponsors, CROs, and regulatory agencies, facilitating timely protocol approvals, resolving study-related questions, and communicating submission status updates to key stakeholders. • Provides regulatory expertise and operational guidance to investigators and research staff by leading onboarding, training, educational sessions, and development of reference materials related to clinical trial policies, procedures, and compliance requirements. • Collaborates with legal teams, sponsors, and study personnel to review informed consent documents, ensure consistency in institutional and contractual language, and implement protocol and staffing updates as required. • Participates in departmental meetings, process improvement initiatives, and cross-functional workgroups to enhance regulatory operations, strengthen compliance practices, and support efficient clinical research program execution.

🎯 Requirements

• Associates degree and 5 years of experience related to the management and conduct of clinical trials in an academic setting OR Bachelor’s degree and 3 years of experience related to the management and conduct of clinical trials in an academic setting. • Working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent form and protocol development.

🏖️ Benefits

• Comprehensive Benefits