Experienced Clinical Research Associate

Location: Belgium - Hybrid
Type: Full-time

Do you want to protect the safety & well-being of subjects and guarantee data quality Do you get energy from daily communication with investigators study coordinators and study teams Do GCP ICH E6 R2 and ISO 14155 have no secrets anymore for you Do you like to perform monitoring visits in hospitals and want to protect the safety & well-being of subjects and guarantee data quality You might be the Clinical Research Associate we are looking for at QbD Clinical!

What youll be doing

• Initiates monitors and closes study sites (remote and on-site). Shares information on patient recruitment study site progress and escalates any issues to the study team

• Ensures that the rights and well-being of subjects are protected that the reported study data are accurate complete and verifiable from source documents conducted in accordance with protocol standard operating procedures ISO/GCP and other applicable regulatory requirements

• Trains supports and advises investigators and site staff

• Is in charge of performance at the site. Proactively identifies study-related issues and finds the appropriate solutions

• Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy legibility completeness and quality of Case Report Form (CRF) to ensure data integrity and subject safety

• Carries out source data verification (SDV) according to the monitoring or SDV plan.

• Ensures data query resolution.

• Prepares monitoring reports and confirmation / follow-up letters in a timely manner

• Manages study supplies and track the device/drug accountability at the study sites

• Cooperates with the site staff for ensuring a proper reporting from the site of the safety events (adverse events and adverse reaction such as AEs/SAEs SUSARs etc.) and their follow up

• Prepares activities related to audits and regulatory inspections together with the Project Leader and/or Project Manager

What you bring

• Master degree in biological or (para-) medical sciences or equivalent by experience

• Minimum of 3 years experience in clinical research in a CRO or as studycoordinator in an hospital setting

• Fluent in Dutch and English (verbally & written extra languages are a big asset)

• Willing to travel internationally (at least 50%)

• Excellent interpersonal skills

• Demonstrates ability to effectively and persuasively communicate verbally and in writing

• Demonstrates ability to adapt to shifting priorities and competing demands

• Ability to maintain composure in difficult circumstances and sensitive to cultural differences.

Whats in it for you

• QbD Group offers you an attractive and competitive salary package that will be tailored to individual needs considering legal requirements and local laws and regulations.

• Join us to build a sustainable career where job security is ensured and lasting meaningful connections are formed.

• As were a knowledge-based company youre guaranteed to embark on a continuous journey of learning and development.

• Be part of our global success story. As an award-winning company we value everyones contribution and celebrate achievements together

Who you are

Our culture is driven by values If this sounds like you youll fit right in:

• Youre resilient and tackle challenges with a positive mindset

• Youre curious and always up for learning something new

• You have a no-nonsense approach honest clear respectful

• Youre innovative and bring ideas not just opinions

• And above all youre serious about your work but not too serious about yourself

About us

We support life sciences companies from idea to patient offering tailored solutions in development clinical regulatory compliance production and distribution. With 500 experts across 8 countries we help drive innovation in ATMP biotech medical devices diagnostics digital health and pharma.

We believe in JPEG:
Joy. Partnership. Going the Extra Mile. Getting Things Done.

You wont just be taking a job youll be joining a community where people grow laugh build and contribute to something bigger.

Interested Lets talk.
Send us your CV and motivation letter. You could be the next one to join the QbD family.