| Lee Doherty, EdM, Regulatory Manager |
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| 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. |
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| Nancy Mori, BS, Cooperative Group Regulatory Specialist |
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| 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. |
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| Mitra Kashanian, Regulatory Specialist |
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| 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.
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| Anthea Buchin, BSc, CCRC, Clinical Trials Facilitator |
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| 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. |
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| Megan Terry, MS, Clinical Trials Facilitator |
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| 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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| Soulaima Houcheime, Administrative Associate |
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| 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. |
Trial Administration