Project Manager

🔥 9 hours ago

🇺🇸 United States – Remote

💵 $44 - $69 / hour

⏰ Full Time

🟢 Junior

🟡 Mid-level

👷‍♀️ Project Manager

👻 Ghost score 10%

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City of Hope

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

🔬 Science

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

Healthcare • Biotechnology • Science

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

• Assist investigators with submission and activation of human subject research to scientific and IRB review committees • Prepare committee applications and collect documents for review • Serve as primary point of contact for faculty, staff, and sponsors for trial submission, approval, and activation • Manage initial study submissions and ensure Disease/Modality Team endorsement • Liaise with sponsors and submit research to external IRBs such as WIRB and/or NCI CIRB • Oversee ongoing regulatory management, including deviations, continuing reviews, and adverse events • Work with investigators and Clinical Trials Support Services on budget development, Medicare coverage analysis, and OnCore calendar builds • Support timely study starts and provide sponsors with regulatory documents • Lead and mentor regulatory coordinators • Assist with onboarding, training, and implementation of new processes or changes • Coordinate clinical trial submissions, including IRB/DSMC/PRMC/WIRB/CIRB approvals, informed consent documents, and activation requirements • Maintain regulatory documentation and ensure compliance with institutional, state, federal, sponsor, FDA, and NCI requirements • Collaborate with investigators, research teams, sponsors, IRB, clinical departments, and internal stakeholders • Lead team meetings, track deadlines and regulatory status, attend professional meetings, and perform other clinical research duties as assigned

🎯 Requirements

• Bachelor’s degree • Minimum of 2 years of experience related to regulatory management and conduct of oncology clinical trials in an academic setting • Working knowledge of clinical trials • Working knowledge of federal, state, and local regulations • Working knowledge of IRB requirements • Working knowledge of consent form and protocol development • Expertise in the regulatory and operations arena of clinical trials • Working knowledge of institutional, federal, and state policies • Ability to coordinate IRB/DSMC/PRMC/WIRB/CIRB approvals and activation requirements • Knowledge of regulatory documentation and FDA and NCI requirements • Experience or ability to support budget development, Medicare coverage analysis, and OnCore calendar builds

🏖️ Benefits

• Comprehensive benefits (details provided via employer benefits link) • Equal opportunity employer