Cancer Institute A national cancer institute
designated cancer center
Cancer Clinical Trials Office

Regulatory Staff

Lee Doherty, EdM, Regulatory Manager Lee's Photo
lee.doherty@stanford.edu 650-736-0176
Lee maintains regulatory related documentation relevant to all cancer institute clinical research including current Lab certifications, current PI CV's, and Medical Licenses. He prepares IND applications and amendments for submission to the FDA. He also tracks safety reports, both from outside sites and Stanford, and submits the required documentation to the IRB and the FDA.
 
Neal Birkett, MS, RAC, Regulatory Specialist, Investigator Initiated Trials
nbirkett@stanford.edu 650-723-6456
Neal is a certified Regulatory Affairs Professional providing advice and input to clinical investigators on phase 1 to 3 therapeutic and diagnostic clinical protocol design and development, as well as clinical trial activation for clinical research administered through the Stanford Cancer Institute (SCI). He is the expert contact for investigator-initiated ("sponsor-investigator) studies. As the primary contact to the FDA, he will coordinate and review initial submissions and amendments for Investigational New Drug Applications and Investigational Device Exemptions, as well as Human Subjects applications to the Stanford RCO IRB. He has primary responsibility for arranging and leading interactions with the FDA regarding SCI studies. He will also be a resource for Stanford investigators assisting in their compliance with ClinicalTrials.gov study listings and results reporting.
 
Anthea Buchin, BSc, CCRC, Clinical Trials Facilitator Anthea's Photo
anthea@stanford.edu 650-724-3155
Anthea assists with study initiation and regulatory tasks related to oncology clinical trials. She works with Cancer Institute Principal Investigators and research personnel to prepare oncology clinical research submissions to Stanford's Administrative Panels on Human Subjects in Medical Research (IRB). She also prepares IND applications and amendments for submission to the FDA.
 
Soulaima Houcheime, Administrative Associate Soulaima's Photo
soulaima@stanford.edu 650-725-9056
Soulaima assists the CCTO Regulatory Manager with safety report processing and tracking. She enters Stanford and IND Outside Safety Reports (OSRs) in OnCore. She completes Regulatory binders for Investigator-initiated studies. She prepares documentation for submission to the FDA, IRB, DSMC, and GCRC.  She updates in OnCore current Lab certifications, and requests PI CV's, and updated Medical Licenses. She tracks in OnCore GCP training for all clinical research staff.
 
Mitra Kashanian, Regulatory Specialist Mitra's Photo
mitrak@stanford.edu 650-721-2534
Mitra assists with Regulatory and Safety tasks related to oncology clinical trials at the Cancer Institute. She works to ensure regulatory compliance by providing oversight on Safety reporting, and by developing procedures to meet the regulations and guidelines. She also trains and works with Cancer Institute Principal Investigators and research personnel to prepare oncology clinical research submissions to Stanford's Administrative Panels on Human Subjects in Medical Research (IRB), and prepares IND applications and amendments for submission to the FDA.
 
Nancy Mori, BS, Cooperative Group Regulatory Specialist Nancy's Photo
nmori@stanford.edu 650-724-0201
Nancy assists with the management of cancer studies that are sponsored by cooperative groups, primarily ECOG, but including NSABP, GOG, COG, and RTOG.  She assists with the regulatory aspects of the studies, including new protocol submissions, informed consents, amendments and/or revisions, all serious adverse events, annual renewals, filling out case report forms, and final reports.  She also works on Stanford's ECOG Affiliates Program providing communication, training, and auditing services to the affiliate sites.
 
Megan Terry, MS, Clinical Trials Facilitator Megan's Photo
meterry@stanford.edu 650-723-2669
Megan assists with study initiation and regulatory tasks related to oncology clinical trials. She works with Cancer Institute Principal Investigators and research personnel to prepare oncology clinical research submissions to Stanford's Administrative Panels on Human Subjects in Medical Research (IRB). She also prepares IND applications and amendments for submission to the FDA.

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