Project Manager

City of Hope is a healthcare and research organization focused on cancer, diabetes, and other life-threatening illnesses. The Project Manager manages regulatory submissions, approvals, and activation of oncology clinical trials, coordinates with investigators, sponsors, and oversight committees, and supports ongoing compliance, budgets, and clinical trial operations. The role also mentors regulatory coordinators and assists with onboarding and process implementation.

Responsibilities:

• Study Start-Up & Activation: Coordinate new clinical trial submissions, including IRB/DSMC/PRMC/WIRB/CIRB approvals, informed consent documents, and activation requirements
• Regulatory & Compliance: Maintain regulatory documentation and ensure studies meet institutional, state, federal, sponsor, FDA, and NCI requirements
• Cross-Functional Coordination: Collaborate with investigators, research teams, sponsors, IRB, clinical departments, and internal stakeholders to ensure timely approvals, activation, and deliverables
• Training & Mentorship: Mentor and train regulatory/clinical research coordinators and assist with onboarding staff on clinical trial policies, procedures, and data entry requirements
• Team & Operational Support: Lead team meetings, track deadlines and regulatory status, support budget/MCA/OnCore activities, attend professional meetings, and perform other clinical research duties as assigned

Requirements:

• Minimum Education: Bachelor's degree
• Minimum Experience: Minimum of 2 years of experience related to the regulatory management and conduct of oncology clinical trials in an academic setting
• Working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent form and protocol development