Project Manager – Clinical Reseach

Join the transformative team atCity 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 guidance of the Senior Director, Clinical Trial Office Operations and the CTO leadership team, the Project Manager (PM) plays a crucial role in assisting investigators with the submission and activation of human subject research to regulatory committees. This includes facilitating prompt submission of protocols, amendments, and updates to regulatory oversight committees and acting as the primary contact for trial submission and approval processes at COH. The PM manages initial study submissions, ensures D/M Team endorsement, and liaises with sponsors and external IRBs like WIRB and NCI CIRB. They oversee ongoing regulatory management for their assigned D/M Team, including deviations, continuing reviews, and adverse events. Additionally, the PM collaborates with investigators and Clinical Trials Support Services (CTSS) for budget development, Medicare coverage analysis, and OnCore calendar builds, while also mentoring regulatory coordinators and ensuring compliance with institutional and regulatory policies.

As a successful candidate, you will:

• Develop and maintain knowledge of institutional protocol submission procedures and requirements.
• Coordinate the preparation and submission of new studies to appropriate committees, ensuring timely completion of the approval process.
• Keep stakeholders informed of protocol approval and activation issues, including regulatory status updates for sponsors and collaborators.
• Interface with internal and external reviewers and agencies, facilitating communication throughout the study start-up process.
• Participate in budget development, Medicare coverage analysis, and OnCore calendar builds for study activation.
• Ensure appropriate maintenance of regulatory documentation for D/M Team studies and liaise with relevant stakeholders as needed.

Your qualifications should include:

• Bachelor’s degree.
• 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.

City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, please click here.

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