Project Manager

Join the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. Our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today. 

Under the direction of the Senior Director, Clinical Trial Office Operations and the CTO leadership team with input from the Disease/Modality (D/M) Team Chairs and the Study Investigators, the Project Manager (PM), as a senior regulatory team member and leader, assists investigators with the submission and activation of their human subject research to the various regulatory committees who review and approve research including scientific review and IRB review.   The CTO regulatory team facilitates a prompt submission of new protocols, study updates, amendments and other regulatory related materials to regulatory oversight committees by preparing committee applications and collecting documents for review.  The PM serves as the primary point of contact for faculty, staff and sponsors for trial submission, approval and activation at COH.

The PM is responsible for managing the initial study submission, ensuring proper D/M Team endorsement and serves as the liaison to sponsor and submits research to external IRBs such as WIRB and/or NCI CIRB. The PM oversees the ongoing regulatory management of studies for their assigned D/M Team for other submission types (e.g., deviations, continuing reviews, adverse events).  COH uses Integrated Research Information System (iRIS) as its electronic protocol submission system and OnCore as the Clinical Trials Management System (CTMS). PM are also responsible for working with investigators and Clinical Trials Support Services (CTSS) for budget development, Medicare coverage analysis (MCA) and OnCore calendar builds to ensure timeliness and accuracy. 

The PM plays a significant role in supporting a timely study start process and is responsible for collecting and provide sponsors with regulatory documents as well as serve as a lead and mentor to regulatory coordinators.  This includes assisting leadership with onboarding, training, and implementation of new processes or changes.  All regulatory coordinators must have a working knowledge of institutional, federal and state policies. The PM must have expertise in the regulatory and operations arena of clinical trials. The position requires frequent interaction with Principal Investigators (PIs) and their research staff including but not limited to clinical research coordinators, research nurses, monitors, data coordinators, as well as the various committee administrative staff.   

• 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.

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.

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