Clinical Research Associate

il y a 1 jour


Mechelen, Belgique SGS Temps plein

Company Description

At **SGS**, you can choose. First of all, out of our various vacancies. However, SGS also gives you another choice. Do you choose to _expand_ or to _enrich_? We are not only looking for colleagues who can go in to depths of their discipline. We are equally as much looking for colleagues who we call ‘connectors’, people who can connect our diversity to our services. To each other. And this way, enrich our business.

**SGS **is the world’s leading inspection, verification, testing and certification company. We’re also the benchmark worldwide for quality and integrity. And that makes us very proud. This can only happen thanks to more than 90 000 colleagues worldwide, with 1650 employees in Belgium only. Our employees give 110% of themselves every day, divided over all expertises, branches and cultures. Our coworkers build their own way inside the company, the services and the expertise.

**SGS Life Sciences **carries out all type of services for pharmaceutical and biotechnology companies, from coordination and running of clinical trials with new molecules or techniques on human beings, to support and consultancy on post marketing registration activities. **SGS Life Sciences **has also expertise in the quality control of pharmaceuticals.

In the spirit of continued growth and to help improve our business, we are currently looking for a **Clinical Research Associate (CRA).**

**Job Description**:
As a 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 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 bio-sciences. 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 organisational 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
**What **we **have to offer**:
Were you already considering a big switch in your career? Maybe this could be your next step. At SGS you can count on an interesting position where you can take responsibility. Come enjoy our fun team of colleagues and on top of that, we will reward you with an interesting salary package (incl. retirement plan, meal vouchers,)

**Do you want to be part of this?



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