Clinical Trials Coordinator- Based in Paris

il y a 4 jours

Courbevoie, France IQVIA Temps plein

**Join us in our exciting journey**

We currently require a motivated and enthusiastic clinical trials professional to join our rapidly growing international division as a Clinical Trials Coordinator.

Our client is one of the TOP 5 pharmaceutical companies who is dedicated and passionate about improving the lives of patients across several therapeutic areas.

**Description of Roles and Responsibilities**

**_Trial and site administration: _**
- 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 o Clinical supply & non-clinical supply management, in collaboration with other country roles
- Manage Labeling requirements and coordinate/sign translation change request

**_ Document management: _**
- Prepare documents and correspondence o 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 o Execute eTMF Quality Control Plan
- Obtain translations of documents

**_ Regulatory & Site Start-Up responsibilities:_**
- 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

**_ Meeting Planning:_**
- Organize meetings (create & track study memos/letters/protocols)
- Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable

**Experience Required**
- Minimum 1-2 years as Studdy Coordinator/CTA or relevant healthcare experience
- B.A./B.S. (Life Science preferred) or equivalent healthcare experience

**CORE Competency Expectations**
- Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Hands on knowledge of Good Documentation Practices
- ICH-GCP Knowledge appropriate to role Behavioral Competency Expectations
- Effective time management, organizational and interpersonal skills, conflict management
- Effective communication with external customers (e.g. sites and investigators)
- High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
- Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
- Demonstrates commitment to Customer focus.
- Able to work independently
- Proactive attitude to solving problems / proposing solutions

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