Clinical Research Coordinator Dutch & French Speaker

at  IQVIA

Internal Job Description
IQVIA is hiring a Clinical Trials Coordinator to provide service to one of our sponsors a well known pharma company with offices in Brussels to support the submissions, budgeting, agreement and payments.

• Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)
• Ensure collation and distribution of study tools and documents
• Update clinical trial databases (CTMS) and trackers
• Clinical supply & non-clinical supply management, in collaboration with other country roles
• Manage Labeling requirements and coordinate/sign translation change request
• Prepare documents and correspondence
• Collate, distribute/ship, and archive clinical documents
• Assist with eTMF reconciliation
• Updating manuals/documents (e.g., patient diaries, instructions)
• Document proper destruction of clinical supplies.
• Prepare Investigator trial file binders
• Execute eTMF Quality Control Plan
• Obtain translations of documents
• In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
• Obtain, track and update study insurance certificates
• Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
• Publish study results for GCTO and RA where required per local legislation