Clinical Research Coordinator Dutch

Il y a 4 mois


Zaventem, Belgique IQVIA Temps plein

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.

**Your duties**
- 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

**Your Profile**
- Bachelor Degree in Administration or similar field.
- At least 1 year of experience in a clinical environment as a CTA, medical assistant.
- French and Dutch and English Proficient Level. Belgium Based.
- GCP knowledge,
- ETMF, CTMS professional usage. Microsoft Office user.
- Hybrid role.

**What you can expect**:

- Resources that promote your career growth
- Leaders that support flexible work schedules
- Programs to help you build your therapeutic knowledge
- Excellent working environment in a stabile, international, reputable company
- Attractive benefits package



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