Avi Lax

Background

About Avi Lax

Experienced senior Clinical Research Associate with a history of working in the hospital & healthcare industry. Skilled in Good Clinical Practice (GCP), Standard Operating Procedure (SOP), Clinical Research, and Clinical Trials. I hold a B.N. in nursing and an M.P.H. in public health from Ben-Gurion University. My major was statics and epidemiology. I’m a fast learner with strong collaboration, excellent interpersonal, organizational, and multi-tasking skills, communication & documentation skills, highly devoted, and getting things done on time and as committed. In the past 6 years, I have worked in a clinical research organization and in sponsor companies, I started as a Clinical Research Associate (CRA), and, since October 2020 I have taken lead CRA responsibilities in MSD Israel. As part of my work as a CRA, I handled clinical databases, managed, supervised, and supported multiple clinical trials in several therapeutic fields: Oncology – Hemato Oncology Cancer- pediatric. phase I/II (Lead CRA) Oncology – Melanoma Cancer- pediatric. phase I/II (Lead CRA) Oncology – Relapsed or refractory solid tumor- pediatric. phase I/II (Lead CRA) Oncology - Ovarian Cancer-phase (Lead CRA) Oncology - Endometrial Carcinoma -phase (Lead CRA) Oncology - Lymphoma – pediatric. phase I/II (Lead CRA) IBU- Ulcerative Colitis, Phase (Lead CRA) Cardiology - Arterial Disease, Phase (CRA) Cardiology – Heart Failure, Phase (CRA) Thrombosis prevention - Anticoagulation therapy - Phase II-(CRA) Thromboembolism of Vein - Anticoagulation therapy - Phase II-(CRA) Metabolic-Diabetic Nephropathy - phase (CRA) Metabolic - Diabetic Kidney disease - phase (CRA). I was acknowledged many times by my employee and colleagues for my hard work and for providing results As a CRA, I performed clinical trial site management activities and site monitoring to confirm site compliance with study protocols, SOPs, and regulations for company clinical trials, training site personnel regarding the trial activities, and GCP, initially and throughout the study. Monitoring and review inform consent forms, study subjects’ data in eCRF to source documents and resolve data queries with PI and Study Coordinator for the company studies. Routine review of the data in the site database to assure no data entry errors. Validated the data in the study’s case report forms (electronic) against source documents. Extracting data and preparing reports per requests. Update and maintain Trial Master File. Submission and notifications to Ethics Committees and Regulatory authorities.