Senior Clinical Research Associate - Sunnyvale, CA (in-house)

Sunnyvale  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Keywords

Description

Primary responsibilities include, but not limited to:
  • Develops and oversees CTMF document control policies, procedures, processes and systems in accordance with all applicable regulatory requirements (including paper-based CTMF storage and maintenance systems as well as electronic CTMF systems)
  • Interacts with Clinical Development department staff and relevant cross-functional departments to establish priorities and deadlines for processing and filing of CTMF required documents
  • Provides support and guidance for internal and external CTMF audits
  • Provides support and guidance for US and Ex-US regulatory authority inspections
  • Develop and/or update Standard Operating Procedures and Work Instructions


Skills Requirements and Education:
  • 5+ years clinical operations experience within drug development
  • Experience collecting and managing clinical trial documents from sites
  • Knowledge of HIPAA regulations as well as GCP / ICH guidelines
  • Bachelors Degree required
  • Ability to independently and effectively manage assigned tasks and projects
  • Proficient in creation of document tracking systems and use of Adobe Acrobat and MS Office Suite
  • No travel is required


To find out more about Real please visit www.realstaffing.com
Start date
03/2014
Duration
temp to hire
From
Real Staffing
Published at
20.03.2014
Project ID:
681882
Contract type
Freelance
To apply to this project you must log in.
Register