Clinical Research Associate

il y a 18 heures

Mechelen, Belgique SGS Temps plein

**Company Description**
As part of the world’s leading testing, inspection and certification company, you share the benefits of our stability and growth; secure employment in a financially stable, Swiss-based company; a proud heritage that has been making the world a better, safer place for over 140 years; and a global, multicultural, and multinational organization.

Grow in a company that is the home of global knowledge and expertise; that operates in a wide range of countries, services and sectors; and that offers you endless opportunities to learn, grow and fulfill you potential

In the spirit of continued growth, we are currently looking for a Clinical research Associate (CRA).

As **clinical research associate** you will be responsible for:

- Participating in the trial set up activities
- Preparing, translating, reviewing, finalizing, tracking and filing study documents
- Conducting site qualification visits, site initiation visits, monitoring visits (on-site and remote, in accordance with the monitoring plan) and close-out visits at assigned clinical site(s) according to applicable regulations, SGS procedures and study specific documents.
- Writing site visit reports
- Verifying the IMP management process at site (storage, return, accountability )
- Managing trial sites
- Ensuring compliance of the trial conduct with the protocol and the applicable guidelines, regulations and SGS procedures

You will work in close collaboration with other CRAs and the Study Team to ensure that quality and milestones are achieved within the budget, and you will maintain regular contacts with the sponsor, project team and investigator.
**Qualifications**
- You have obtained a university degree (equal to 4 years of college) in (para-) medical, pharmaceutical, sciences, life-sciences or biosciences. An equally recognized degree and/or relevant qualifications by experience may also be acceptable and will be evaluated on a case-by-case basis.
- You can work in a self-driven capacity, with a sense of urgency and limited need for oversight
- ** You are fluent in both Dutch**and English; knowledge of French is an asset
- You are a strong communicator and have strong organizational skills
- You work well independently as well as in a team
- You are constantly dotting the i's and crossing the t's
- you have a good knowledge of ICH GCP and European Directives 2001
- You are accountable, helpful, dedicated and flexible
- You are willing to travel, if necessary

**Additional Information** Do you want to be part of this?**

Were you already considering a big switch in your career? Maybe this could be your next step.

Please note we cannot support a work permit procedure or relocation;** Fluent Dutch is a must

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