Lilach Ofri

About Lilach Ofri

Over 2 years of experience as a Clinical Research Assistant• Reviewed documents and reports in order to be in compliance with GCP guidelines.• Obtained regulatory documents from participating sites.• Tracked study related documents in order to keep TMF (Trial Master Files) up to date.• Assisted with protocol amendments, design of case report forms, and IRB submissions. • Managed all database aspects within the department, including training data entry personnel • Generated queries to reconcile any discrepancies on case report forms; data entry into VELOS software. • Involved in the collection, documentation, monitoring, and analysis of clinical research data. • Currently pursuing a Clinical Research Design and Management Certificate from UC Santa Cruz (Extension program)Specialties: • Management / Organizational Abilities: Organized, take-charge professional with exceptional follow-through abilities and detail orientation • Building Relationships: Outstanding history of building and maintaining relationships• Reputation for going “above and beyond.”• Problem Solving: with resourcefulness abilities• Proficient in Microsoft Office Products.

Experience

1. Clinical Research Associate

   Acclarent

   Jan 2007 — Present

   Support and coordinate variety of activities in clinical trials.• Communicate and train site personal on study procedures, forms and documentation. • Assist with protocol amendments, design of case report forms, and IRB submissions. • Review documents and reports in order to be in compliance with GCP guidelines.• Obtain regulatory documents from participating sites.• Work with vendors to obtain additional study supply as needed, and/or documents translation. • Ship devices for investigational purposes, and track clinical inventory. • Involve in the collection, documentation, monitoring, and analysis of clinical research data. • Generate queries to reconcile any discrepancies on case report forms; data entry into VELOS software. • Track study related documents in order to keep TMF (Trial Master Files) up to date.• Collaborate on the preparation of manuscripts for publication. • Manage all database aspects within the department, including training and managing data entry personnel • Create and maintain clinical data management work instructions. • Support database validation activities, including writing test scripts, work instructions and final report• Assist with CAPA closure.

Education

• Technion - Israel Institute of Technology

  B.sc, QA, ISO 9000, GMP, Micobiology(also labs experience), Biotechnology,System Reliability Control, etc.

  2000 — 2005

• University of California, Santa Cruz

  Pursuing a Clinical Research Design and Management Certificate, Clinical Trials

  2007 — 2009

Skills

• Biotechnology
• Clinical Trials