Project Manager - Startup & Feasibility jobs in United States
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City of Hope · 1 week ago

Project Manager - Startup & Feasibility

City of Hope is a transformative organization dedicated to changing lives in the fight against cancer and other life-threatening illnesses. The Project Manager will assist investigators with the submission and activation of human subject research, serving as the primary contact for trial submissions and ensuring compliance with regulatory requirements.

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Comp. & Benefits

Responsibilities

Management of 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)
PMs are 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
Holds a significant role in supporting a timely study start process and is responsible for collecting and providing sponsors with regulatory documents as well as serving as a lead and mentor to regulatory coordinators. This includes assisting leadership with onboarding, training, and implementation of new processes or changes
PM will exhibit expertise in the regulatory and operations arena of clinical trials
Will frequently interact 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

Qualification

Regulatory managementOncology clinical trialsIRB requirementsClinical Trials Management SystemBudget developmentBachelor’s degreeTrainingMentoring

Required

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

Company

City of Hope

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City of Hope is a cancer research and treatment non-profit organization specializing in diabetes and other life-threatening illnesses.

Funding

Current Stage
Late Stage
Total Funding
$10.3M
Key Investors
California Institute for Regenerative Medicine
2024-05-20Grant· $5.4M
2022-02-22Grant· $4.9M

Leadership Team

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Samuel Lau
Vice President Marketing & Digital Communications
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Alan H. Bryce
Chief Clinical Officer
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Company data provided by crunchbase