CHA Hollywood Presbyterian Medical Center · 6 days ago
Project Manager - Startup & Feasibility
United States
Full-time
Remote
Entry, Mid Level
$43.18/hr - $66.92/hr
2+ years expCHA Hollywood Presbyterian Medical Center is part of City of Hope, a transformative organization dedicated to fighting cancer and other life-threatening illnesses. The Project Manager will assist in the management of human subject research submissions, ensuring compliance with regulatory requirements and acting as a liaison between investigators and regulatory bodies.
Health CareHospitalMedical
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
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
CHA Hollywood Presbyterian Medical Center
CHA Hollywood Presbyterian Medical Center is a full-service, acute care hospital. It serves multicultural communities with quality medical.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Jamie Yoo
Chief Executive Officer
Robert Allen
President and CEO
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