Shiri Blau Biderman

As a clinical monitor with a nursing background, I am familiar with the evaluation, initiation, monitoring and close-out procedures in various indications: Neurology: Parkinson, MS. Gastroenterology: Ulcerative colitis. Oncology: Colo rectal cancer, metastatic 1st line, 2nd line, colon cancer adjuvant. Metastatic breast cancer (phase 3). Non small cell lung cancer Cardio vascular: Acute coronary syndrome undergoing PCI. Cardio vascular – medical device: BM &DE stents.

Responsibilities included: Feasibilities, delivery of GCP trainings, submissions to ethic committees, initiation visits, monitoring visits and SDV, query resolution, drug accountability, management of SAEs, audits and re labeling process.

Responsibilities included: Creation and design of study protocols and CRF’s. Also feasibilities, delivery of GCP trainings, submissions to ethic committees, site selection visits, initiation visits, monitoring visits and SDV, query resolution, management of SAEs, submissions to regulatory body, closing sites and organization of investigator meeting.