Clinical Research Assistant
- Excellent employment opportunity for a Clinical Research Assistant in the Wilmington, DE area.
- 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 company Authoring Guide for Regulatory Documents to support publishing in GEL.
- Contribute to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e. Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities (not for international studies).
- Set-up, populate and accurately maintain information in company tracking and communication tools (e.g. IMPACT, SharePoint etc.) and support others in the usage of these systems.
- To be considered for this Clinical Research Assistant job opportunity a Bachelor’s degree is preferred.
- 3-5 years of experience in clinical trial DOCUMENT MANAGEMENT and regulatory documents is required.
- 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.
- Good verbal and written communication is required.
- Good interpersonal skills and ability to work in an international team environment.
- Willingness and ability to train others on study administration procedures.
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