Clinical Trial Associate - Job ID:4713
CTA will assist with the lifecycle management and associated processes (from study set up to archiving) of Trial Master Files (TMF) for clinical trials
- Core responsibilities applicable for studies following electronic trial master file (eTMF) procedure:
- Supports Clinical Trial Leaders (CTLs) in the set up of an electronic Trial Master file process for assigned studies
- Work with document systems and related group to ensure groups are trained on document management systems or other agreed process for electronic TMF document delivery
- Work with sites to attain required regulatory documentation in a timely manner as required to meet timelines for study start up
- Support CTLs in the maintenance of trial documentation.
- Scan (or coordinate scanning by vendor), properly name, and import documents into the Novartis document management system.
- Act as subject matter expert and/or super user for document systems and other TMF technical tools.
- Support set-up of electronic TMF Table of Content at study start and update as appropriate during study in agreement with CTL
- Set-up of paper TMF folder structure & receipt of paper TMF documents from the Clinical Research Associate (CRA)/site at defined intervals during the trial for those originals still required to be on file, arrange for archiving of paper TMF at study end
- BS/MS wioth 2+ years experience in clinical research.
- Must have experience with TMFs
- Good knowledge of regulatory requirements and best practices pertaining to trial document management and archiving of clinical trial documentation
- Good knowledge of Good Clinical Practice
Candidates must live local and be a US Citizen or Green Card Holder
Email resume to: firstname.lastname@example.org
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.
Commonwealth Sciences, Inc.