Clinical Trial Manager
Current- Onboard new protocol staff and orient them to the role, organization, and various parties involved in cooperative group clinical trials- Prepare and maintain training materials and guidance documents for new and existing protocol staff- Manage the project development and implementation of cancer treatment clinical trials for gastrointestinal, hematologic, and neurological cancers, including two prospective FDA registration trials- Assist Alliance Committee Chairs and Study Teams in the development of clinical trials from conceptual stages to trial activation and through study closure- Lead the development of the protocol document, distribute drafts for review, integrate technical and scientific information from multiple sources, and incorporate necessary revisions- Format, proofread, and edit the protocol and informed consent documents. Ensure study documents are in compliance with Alliance model protocol and policies and procedures as well as federal regulatory requirements and guidelines- Serve as first point of contact for investigators and site personnel inquiring about study logistics, requirements, policies, procedures, issues, and data submission- Prepare protocol amendments as needed and submit to federal agencies for scientific and regulatory review- Liaise with funding agencies’ staff, the Cancer Trials Support Unit, and the National Cancer Institute Central Institutional Review Board regarding studies in development or undergoing revision