Clinical Research Document Specialist Job

CLINICAL RESEARCH DOCUMENT SPECIALIST needed for a CONTRACT opportunity with Yoh's client located in Cambridge, MA.

The Big Picture - Top Skills You Should Possess:
- Supports Clinical Trial Leaders (CTLs) in the setup 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
- As part of the global CS&I trial document group:
- Participate in the creation/harmonization of templates/guidances, eg trial document delivery plan template, document tracking tools, training materials, TMF quality compliance (QC) guidances.
- Assist in maintaining a global tracking of trial master file locations (during study and upon archiving)
- As agreed, act as back-up or provide support to other Trial Document Specialists globally
- Extended/Optional responsibilities as agreed depending on local requirements and resource availability for selected studies

What You Need to Bring to the Table:
- Good organizational and interpersonal skills.
- 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
- Ability to work independently and manage multiple priorities.
- Computer literate.
- Fluent in English

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.

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