Clinical Research Associate F/m/x

il y a 3 semaines

Beerse, Belgique Amaris Consulting Temps plein

**Who are we?**:
**Amaris Consulting** is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

**Brief Call**: Our process typically begins with a brief virtual/phone conversation to get to know you The objective? Learn about you, understand your motivations, and make sure we have the right job for you

**Interviews** (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities

**Case study**: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

We look forward to meeting you
**Job description**:
**Roles**

**&**

**Responsibilities**:

- Participate in the development of study protocols, informed consent forms, and other essential study documents.
- Assist in the preparation of regulatory submissions for ethics committee/institutional review board (EC/IRB) approval.
- Conduct pre-study site evaluations and initiate clinical trial sites.
- Train site staff on study protocols, data collection processes, and compliance with regulatory requirements.
- Perform routine monitoring visits to ensure the conduct of the trial in accordance with the protocol, Good Clinical Practice (GCP), and applicable regulatory requirements.
- Verify the accuracy and completeness of clinical trial data through source data verification.
- Collaborate with data management teams to ensure timely and accurate data collection, entry, and query resolution.
- Review and maintain study-related documentation, including case report forms (CRFs) and study files.
- Monitor and report adverse events and protocol deviations in accordance with regulatory requirements.
- Work closely with safety teams to ensure proper documentation and reporting of safety information.
- Coordinate site close-out activities, ensuring all required documentation is collected and filed appropriately.
- Assist in the preparation of final study reports and contribute to data analysis.

**The Ideal Profile**

***:

- Bachelor's degree in a relevant scientific or healthcare discipline.
- Thorough understanding of GCP, ICH guidelines, and regulatory requirements.
- Strong organizational and communication skills.
- Ability to travel as needed.
- Fluent in English, any other language is an asset.

**6 advantages of joining Amaris Consulting**:

- In-depth **training** so that you can gain more **technical **skills.
- **Certifications** that will allow you to gain a competitive edge.
- An R&D Lab that will give you the opportunity to develop your skills that you can then use on **innovative projects**:

- Opportunity to pitch your ideas to help us grow a **successful** business
- Regular **coaching and mentoring** provided by our Senior Technical Consultants who will allow you to become, in turn, an expert in your profession.
- An **attractive, tailor-made and evolving** career path

**What about my salary?**

It all depends on your profile and your skills, but we offer a fixed salary in line with the market and scalable throughout your career with us.

Most importantly, you'll be part of an independent company that values:
**Agility**: we are flexible, dynamic and offer a stimulating environment.

**International**: daily international exchanges and mobility opportunities around the world.

**Intrapreneurship**: if you want to invest in related topics or develop a Business Unit, Amaris is for you

**Supportive Leadership**: with a limited number of consultants, your manager will adapt to your profile and accompany you throughout your professional journey

Still not convinced ? Because we are committed to giving meaning to our daily actions, Mantu is **committed to sustainability** (reduction of our carbon footprint, collaboration with various associations, diversity and inclusion policy).

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