Experienced Clinical Research Associate
Location: 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 you’ll 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 applicableregulatory 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 your local language 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.
What’s 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 we’re a knowledge-based company, you’re 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 everyone’s contribution and celebrate achievements together
Who you are
Our culture is driven by values If this sounds like you, you’ll fit right in:
You’re resilient and tackle challenges with a positive mindset
You’re curious and always up for learning something new
You have a no-nonsense approach honest, clear, respectful
You’re innovative and bring ideas, not just opinions
And above all, you’re 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 won’t just be taking a job - you’ll be joining a community where people grow, laugh, build, and contribute to something bigger.
Interested? Let’s talk.
Send us your CV and motivation letter. You could be the next one to join the QbD family.