Clinical Documentation Specialist Job

CLINICAL DOCUMENTATION SPECIALIST needed for a CONTRACT opportunity with Yoh's client located in WILMINGTON, DE.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- CTMS
- TMF
- Clinical documentation

WHAT YOU'LL BE DOING:

- Operational responsibility to set-up the local Trial Master File (eTMF) and Investigator Site File including tracking of documents.
- Maintain and close the local TMF (in electronic or paper form depending on study) ensuring International Conference of Harmonization Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements.
- Support the CRA in the maintenance and close out activities for the ISF.
- Contribute to the production and maintenance of study documents, ensuring template and version compliance.
- Create and/or import clinical-regulatory documents into the Global Electronic Library (GEL) according to the Global Document List (GDL) ensuring compliance with the Authoring Guide for Regulatory Documents to support publishing in GE
- Contribute to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards ie Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities (not for international studies).
- Set-up, populate and accurately maintain information in tracking and communication tools (eg IMPACT, SharePoint etc) and support others in the usage of these systems

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelor's degree is preferred
- Three to five (3-5) years of experience in clinical trial document management and regulatory documents is required
- Three to five (3-5) years of CTMS (Clinical Trial Management System ) experience, preferably with IMPACT
- Experience with electronic trial master file system(s) including uploading, reviewing, QC, approval of study required documents.
- Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines
- Working knowledge of clinical study documents

GET HIRED, APPLY NOW!

RECRUITER: Krista Leach

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

J2W: CLINICAL

TAX TERM: CON_W2

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